Trial Outcomes & Findings for Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma (NCT NCT04405245)

NCT ID: NCT04405245

Last Updated: 2023-05-25

Results Overview

Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

194 participants

Primary outcome timeframe

Baseline to Day 28

Results posted on

2023-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	AKB-9778 4% QD + Latanoprost • AKB-9778 4% QD (AM) and placebo for AKB-9778 ophthalmic solution QD (PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution	AKB-9778 4% BID + Latanoprost • AKB-9778 4% BID (AM \& PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution	Placebo BID + Latanoprost • Placebo for AKB-9778 4% ophthalmic solution BID (AM \& PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily Placebo: placebo for AKB-9778 4% ophthalmic solution
Overall Study STARTED	65	65	64
Overall Study COMPLETED	65	64	64
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AKB-9778 4% QD + Latanoprost • AKB-9778 4% QD (AM) and placebo for AKB-9778 ophthalmic solution QD (PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution	AKB-9778 4% BID + Latanoprost • AKB-9778 4% BID (AM \& PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution	Placebo BID + Latanoprost • Placebo for AKB-9778 4% ophthalmic solution BID (AM \& PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily Placebo: placebo for AKB-9778 4% ophthalmic solution
Overall Study Adverse Event	0	1	0

Baseline Characteristics

Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AKB-9778 4% QD + Latanoprost n=130 Eyes • AKB-9778 4%(AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=130 Eyes • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=128 Eyes • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for razuprotafib opthalmic solution	Total n=388 Eyes Total of all reporting groups
Age, Continuous	68.3 years STANDARD_DEVIATION 8.81 • n=99 Participants	65.6 years STANDARD_DEVIATION 10.85 • n=107 Participants	65.9 years STANDARD_DEVIATION 10.55 • n=206 Participants	66.6 years STANDARD_DEVIATION 10.13 • n=7 Participants
Sex: Female, Male Female	40 Participants n=99 Participants	37 Participants n=107 Participants	43 Participants n=206 Participants	120 Participants n=7 Participants
Sex: Female, Male Male	25 Participants n=99 Participants	28 Participants n=107 Participants	21 Participants n=206 Participants	74 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=99 Participants	6 Participants n=107 Participants	3 Participants n=206 Participants	18 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=99 Participants	59 Participants n=107 Participants	61 Participants n=206 Participants	176 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	20 Participants n=99 Participants	17 Participants n=107 Participants	16 Participants n=206 Participants	53 Participants n=7 Participants
Race (NIH/OMB) White	45 Participants n=99 Participants	47 Participants n=107 Participants	47 Participants n=206 Participants	139 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Diagnosis Open-angle glaucoma - Study Eye	33 Eyes n=40 Eyes	43 Eyes n=23 Eyes	42 Eyes n=50 Eyes	118 Eyes n=50 Eyes
Diagnosis Ocular hypertension - Study Eye	32 Eyes n=40 Eyes	22 Eyes n=23 Eyes	22 Eyes n=50 Eyes	76 Eyes n=50 Eyes
Diagnosis Open-angle glaucoma - Fellow Eye	33 Eyes n=40 Eyes	42 Eyes n=23 Eyes	42 Eyes n=50 Eyes	117 Eyes n=50 Eyes
Diagnosis Ocular hypertension - Fellow Eye	32 Eyes n=40 Eyes	23 Eyes n=23 Eyes	22 Eyes n=50 Eyes	77 Eyes n=50 Eyes
Randomization Intraocular Pressure (Study Eye) Diurnal Mean < 26 mmHg	49 Participants n=99 Participants	49 Participants n=107 Participants	48 Participants n=206 Participants	146 Participants n=7 Participants
Randomization Intraocular Pressure (Study Eye) Diurnal Mean >=26 mmHg	16 Participants n=99 Participants	16 Participants n=107 Participants	16 Participants n=206 Participants	48 Participants n=7 Participants
Study Eye Screening Corneal Thickness (micrometers)	544.8 micrometer STANDARD_DEVIATION 30.27 • n=99 Participants	554.0 micrometer STANDARD_DEVIATION 28.57 • n=107 Participants	554.7 micrometer STANDARD_DEVIATION 30.58 • n=206 Participants	551.2 micrometer STANDARD_DEVIATION 30.00 • n=7 Participants
Study Eye Screening Intraocular Pressure (mmHg)	20.34 mmHg STANDARD_DEVIATION 1.981 • n=99 Participants	20.54 mmHg STANDARD_DEVIATION 2.283 • n=107 Participants	20.11 mmHg STANDARD_DEVIATION 2.003 • n=206 Participants	20.33 mmHg STANDARD_DEVIATION 2.091 • n=7 Participants
Study Eye Baseline Diurnal Mean Intraocular Pressure (mmHg)	24.83 mmHg STANDARD_DEVIATION 1.559 • n=99 Participants	25.16 mmHg STANDARD_DEVIATION 2.039 • n=107 Participants	25.11 mmHg STANDARD_DEVIATION 1.967 • n=206 Participants	25.03 mmHg STANDARD_DEVIATION 1.862 • n=7 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28

Population: The ITT population will include all randomized subjects who have received at least one dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized.

Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=65 Participants • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=65 Participants • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=64 Participants • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)	-6.95 mmHg Standard Error 0.258	-7.95 mmHg Standard Error 0.257	-7.04 mmHg Standard Error 0.259

SECONDARY outcome

Timeframe: Baseline to Day 14

Population: The Intent-to-Treat population includes all randomized subjects who received at least one dose of study medication. the primary population for efficacy analyses and was used to summarize all efficacy variables and summarizes subjects as randomized.

Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=65 Participants • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=65 Participants • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=64 Participants • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)	-6.75 mmHg Standard Error 0.259	-7.62 mmHg Standard Error 0.258	-7.03 mmHg Standard Error 0.260

SECONDARY outcome

Timeframe: Baseline to Day 14 and Baseline to Day 28

Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=130 eyes • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=130 eyes • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=128 eyes • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) Baseline to Day 14	-6.68 mmHg Standard Error 0.250	-7.53 mmHg Standard Error 0.250	-6.91 mmHg Standard Error 0.252
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) Baseline to Day 28	-6.83 mmHg Standard Error 0.255	-7.86 mmHg Standard Error 0.255	-6.93 mmHg Standard Error 0.257

SECONDARY outcome

Timeframe: Baseline to Day 14 and Baseline to Day 28

Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=130 eyes • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=130 eyes • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=128 eyes • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) Baseline to Day 14	18.01 mmHg Standard Deviation 2.445	17.37 mmHg Standard Deviation 2.272	17.95 mmHg Standard Deviation 2.383
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) Baseline to Day 28	17.86 mmHg Standard Deviation 2.514	17.03 mmHg Standard Deviation 2.019	17.92 mmHg Standard Deviation 2.580

SECONDARY outcome

Timeframe: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28

Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=65 Participants • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=65 Participants • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=64 Participants • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Mean Observed IOP at Each Time Point on Days 14 and 28 Day 14, 08:00	19.54 mmHg Standard Deviation 2.970	18.25 mmHg Standard Deviation 2.652	18.75 mmHg Standard Deviation 3.289
Mean Observed IOP at Each Time Point on Days 14 and 28 Day 14, 10:00	17.98 mmHg Standard Deviation 2.907	17.32 mmHg Standard Deviation 2.772	18.02 mmHg Standard Deviation 2.973
Mean Observed IOP at Each Time Point on Days 14 and 28 Day 14, 12:00	17.50 mmHg Standard Deviation 3.059	17.25 mmHg Standard Deviation 2.767	17.87 mmHg Standard Deviation 2.624
Mean Observed IOP at Each Time Point on Days 14 and 28 Day 14, 16:00	17.52 mmHg Standard Deviation 2.805	17.17 mmHg Standard Deviation 2.762	17.56 mmHg Standard Deviation 2.696
Mean Observed IOP at Each Time Point on Days 14 and 28 Day 28, 08:00	18.81 mmHg Standard Deviation 2.977	18.13 mmHg Standard Deviation 2.417	18.95 mmHg Standard Deviation 2.986
Mean Observed IOP at Each Time Point on Days 14 and 28 Day 28, 10:00	17.97 mmHg Standard Deviation 2.878	17.02 mmHg Standard Deviation 2.558	17.90 mmHg Standard Deviation 2.986
Mean Observed IOP at Each Time Point on Days 14 and 28 Day 28, 12:00	17.60 mmHg Standard Deviation 2.791	16.55 mmHg Standard Deviation 2.695	17.51 mmHg Standard Deviation 2.914
Mean Observed IOP at Each Time Point on Days 14 and 28 Day 28, 16:00	17.35 mmHg Standard Deviation 2.507	16.97 mmHg Standard Deviation 2.377	17.82 mmHg Standard Deviation 3.052

SECONDARY outcome

Timeframe: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28

Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=65 Participants • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=65 Participants • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=64 Participants • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Day 14, 08:00	-6.66 mmHg Standard Deviation 2.551	-8.13 mmHg Standard Deviation 3.225	-7.59 mmHg Standard Deviation 3.130
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Day 14, 10:00	-7.02 mmHg Standard Deviation 2.607	-7.88 mmHg Standard Deviation 2.831	-7.45 mmHg Standard Deviation 2.388
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Day 14, 12:00	-6.79 mmHg Standard Deviation 2.378	-7.52 mmHg Standard Deviation 2.761	-6.83 mmHg Standard Deviation 2.381
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Day 14, 16:00	-6.29 mmHg Standard Deviation 2.698	-7.10 mmHg Standard Deviation 2.841	-6.36 mmHg Standard Deviation 2.332
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Day 28, 08:00	-7.39 mmHg Standard Deviation 2.977	-8.25 mmHg Standard Deviation 2.826	-7.38 mmHg Standard Deviation 2.715
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Day 28, 10:00	-7.03 mmHg Standard Deviation 2.665	-8.19 mmHg Standard Deviation 2.536	-7.57 mmHg Standard Deviation 2.549
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Day 28, 12:00	-6.69 mmHg Standard Deviation 2.383	-8.21 mmHg Standard Deviation 2.486	-7.18 mmHg Standard Deviation 2.598
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Day 28, 16:00	-6.45 mmHg Standard Deviation 2.279	-7.30 mmHg Standard Deviation 2.731	-6.10 mmHg Standard Deviation 2.593

SECONDARY outcome

Timeframe: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28

Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=65 Participants • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=65 Participants • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=64 Participants • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Day 28, 10:00	-28.12 percent change Standard Error 1.207	-32.36 percent change Standard Error 1.205	-29.70 percent change Standard Error 1.217
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Day 14, 08:00	-25.52 percent change Standard Error 1.292	-30.41 percent change Standard Error 1.291	-28.68 percent change Standard Error 1.301
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Day 14, 10:00	-28.09 percent change Standard Error 1.221	-31.10 percent change Standard Error 1.219	-29.29 percent change Standard Error 1.231
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Day 14, 12:00	-28.21 percent change Standard Error 1.213	-30.19 percent change Standard Error 1.211	-27.53 percent change Standard Error 1.219
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Day 14, 16:00	-26.48 percent change Standard Error 1.285	-28.94 percent change Standard Error 1.287	-26.61 percent change Standard Error 1.293
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Day 28, 08:00	-28.19 percent change Standard Error 1.218	-30.96 percent change Standard Error 1.218	-27.93 percent change Standard Error 1.227
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Day 28, 12:00	-27.65 percent change Standard Error 1.209	-33.09 percent change Standard Error 1.206	-29.03 percent change Standard Error 1.215
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Day 28, 16:00	-27.21 percent change Standard Error 1.227	-29.65 percent change Standard Error 1.229	-25.58 percent change Standard Error 1.235

SECONDARY outcome

Timeframe: Baseline to Day 14 and Baseline to Day 28

Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=65 Participants • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=65 Participants • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=64 Participants • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 Baseline to Day 14	-27.08 percent change Standard Deviation 7.875	-30.29 percent change Standard Deviation 8.550	-28.16 percent change Standard Deviation 7.931
Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 Baseline to Day 28	-27.83 percent change Standard Deviation 8.711	-31.67 percent change Standard Deviation 7.219	-28.19 percent change Standard Deviation 8.523

SECONDARY outcome

Timeframe: Baseline to Day 28

Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population

Outcome measures

Outcome measures
Measure	AKB-9778 4% QD + Latanoprost n=65 Participants • AKB-9778 4% QD (AM) and placebo for AKB-9778 4% ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily razuprotafib: razuprotafib opthalmic solution	AKB-9778 4% BID + Latanoprost n=65 Participants • AKB-9778 4% BID (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Razuprotafib: Razuprotafib opthalmic solution	Placebo Twice Daily + Latanoprost n=64 Participants • Placebo for AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost opthalmic solution to be dosed once daily Placebo: placebo for Razuprotafib opthalmic solution
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=35%	13 Participants	18 Participants	11 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentage of Subjects Achieving Pre-Specified Mean IOP: <=22 mmHg	60 Participants	63 Participants	58 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentage of Subjects Achieving Pre-Specified Mean IOP: <=20 mmHg	56 Participants	60 Participants	51 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentage of Subjects Achieving Pre-Specified Mean IOP: <=18 mmHg	35 Participants	46 Participants	35 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentage of Subjects Achieving Pre-Specified Mean IOP: <=16 mmHg	14 Participants	20 Participants	13 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentage of Subjects Achieving Pre-Specified Mean IOP : <=14 mmHg	3 Participants	6 Participants	4 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=2 mmHg	63 Participants	65 Participants	64 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=3 mmHg	62 Participants	65 Participants	63 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=4 mmHg	61 Participants	64 Participants	60 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=6 mmHg	47 Participants	57 Participants	44 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=8 mmHg	21 Participants	32 Participants	20 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percentages of Subjects Achieving Mean Change (IOP Reduction from Baseline) : >=10 mmHg	3 Participants	9 Participants	4 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=5%	63 Participants	65 Participants	64 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=10%	62 Participants	65 Participants	63 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=15%	61 Participants	64 Participants	59 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=20%	57 Participants	62 Participants	53 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=25%	43 Participants	55 Participants	41 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=30%	25 Participants	40 Participants	27 Participants
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Percent Mean Change in Diurnal Mean IOP Levels (IOP Percent Reduction from Baseline): >=40%	4 Participants	10 Participants	4 Participants

Adverse Events

AKB-9778 4% QD + Latanoprost

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

AKB-9778 4% BID + Latanoprost

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo BID + Latanoprost

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

David Bauer

EyePoint Pharmaceuticals, Inc

Phone: 8573410747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Product acquired from Aerpio with limited transfer of documents. Site CTAs not provided.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	AKB-9778 4% QD + Latanoprost n=65 participants at risk • AKB-9778 4% QD (AM) and placebo for AKB-9778 ophthalmic solution QD (PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution	AKB-9778 4% BID + Latanoprost n=65 participants at risk • AKB-9778 4% BID (AM \& PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily AKB-9778: AKB-9778 4% ophthalmic solution	Placebo BID + Latanoprost n=64 participants at risk • Placebo for AKB-9778 4% ophthalmic solution BID (AM \& PM) plus latanoprost QD (PM) for 28 days Latanoprost ophthalmic solution: Latanoprost ophthalmic solution to be dosed once daily Placebo: placebo for AKB-9778 4% ophthalmic solution
Eye disorders Conjunctival hyperaemia	40.0% 26/65 • Number of events 40 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	60.0% 39/65 • Number of events 63 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	14.1% 9/64 • Number of events 11 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Conjunctivitis allergic	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Dry Eye	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	3.1% 2/64 • Number of events 2 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Eye Pruritus	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	3.1% 2/65 • Number of events 2 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	4.7% 3/64 • Number of events 3 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Eyelid margin crusting	3.1% 2/65 • Number of events 2 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Iritis	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Photophobia	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Punctate keratitis	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.6% 1/64 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Retinal artery emoblism	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Vision blurred	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.6% 1/64 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Visual impairment	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Eye disorders Vitreous disorder	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
General disorders Instillation site foreign body sensation	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
General disorders Instillation site pain	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	3.1% 2/65 • Number of events 2 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	6.2% 4/64 • Number of events 4 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
General disorders Instillation site pruritis	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	3.1% 2/65 • Number of events 2 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
General disorders Sensation of foreign body	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Nervous system disorders Migraine with aura	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Gastrointestinal disorders Glossodynia	1.5% 1/65 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/64 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Gastrointestinal disorders Nausea	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.6% 1/64 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Infections and infestations Urinary tract infection	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.6% 1/64 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Nervous system disorders Dysgeusia	4.6% 3/65 • Number of events 3 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	12.3% 8/65 • Number of events 8 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.6% 1/64 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.
Nervous system disorders Headache	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	0.00% 0/65 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.	1.6% 1/64 • Number of events 1 • Treatment-emergent adverse events were collected for the entire duration of the study, which was approximately 11 weeks. The Investigator is to report all directly observed AEs and all AEs spontaneously reported by the study subject. In addition, each study subject will be questioned about AEs at each visit following the initiation of treatment.