A stem cell therapy for geographic atrophy improved vision in a phase Ib trial, and the first gene therapy for optic neuropathies was administered. Next-generation anti-VEGF agents are also extending treatment intervals in retinal vascular disease.
Axpaxli (OTX-TKI) met its primary endpoint in the SOL-1 Phase 3 trial, demonstrating superiority over aflibercept in preserving visual acuity in wet AMD patients at week 36. A single injection of the intravitreal hydrogel led to higher rescue-free rates and better fluid control, supporting potential for reduced treatment burden. Ocular Therapeutix plans to submit a New Drug Application to the FDA.
4D Molecular Therapeutics (Nasdaq: FDMT) granted a total of 229,700 restricted stock units to 20 new non-executive hires across three awards in 2026 under its Employment Inducement Award Plan. The grants occurred on February 10, April 14, and July 14, as part of Nasdaq-compliant inducement awards.
Ocular Therapeutix stock surged 30% in premarket trading as the company prepared to release topline Phase 3 data for AXPAXLI in wet AMD. The SOL-1 trial results will be presented at the Macula Society meeting later in February. The company plans to file for FDA approval using one-year data if results are favorable.
Two new interchangeable Lucentis biosimilars — Lupin's Ranluspec and Formycon/Bioeq's Nufymco — have received FDA approval, while Xbrane's Lucamzi is under review with an October target date. The Lucentis global market was valued at $630 million in 2024.
4D Molecular Therapeutics said 4D-150 is in Phase 3 for wet AMD and nearing Phase 3 in diabetic macular edema. The company reported rapid enrollment, 18-month treatment burden reductions and favorable safety data.
EyePoint's DSMC recommended continuing its Phase 3 wet AMD trials without protocol changes after a third review. Topline data for LUGANO are expected mid-2026, with LUCIA shortly after. The company ended 2025 with $300 million in cash and a runway into Q4 2027.
Kodiak Sciences' experimental drug Zenkuda achieved 62.5% response rate in diabetic retinopathy trial with 85% reduction in sight-threatening complications. The company plans to accelerate FDA submission while preparing for wet AMD study readout in Q3 2026. Shares surged 68.6% following the positive late-stage results.
Ocular Therapeutix's experimental drug Axpaxli showed superior vision maintenance compared to Regeneron's Eylea in a late-stage wet AMD trial. Meanwhile, Ocugen reported 12-month data showing its gene therapy OCU410 reduced geographic atrophy lesions by 31%, though less than earlier interim results. Both companies are advancing toward regulatory submissions and further clinical development.
Sanofi has submitted a revised acquisition bid for Ocular Therapeutix ahead of pivotal Phase 3 trial results for AXPAXLI, a sustained-release treatment for wet AMD. The deal could position Sanofi to re-enter the ophthalmology market it previously abandoned. The acquisition would give Sanofi access to innovative hydrogel delivery technology with potential applications beyond eye disease.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07389577 |
A Study to Compare JL14002 to Lucentis® in Subjects With Wet Age-related Macular Degeneration (wAMD) |
COMPLETED | PHASE3 |
| NCT07338513 |
User-centric Study of Patients' Receptiveness Towards the Web-based Automated Vision Impairment Gaze-tracking Analysis Systems |
NOT_YET_RECRUITING | |
| NCT07178249 |
Evaluating the Safety and Preliminary Efficacy of EXG202 Gene Therapy for Neovascular AMD |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06952452 |
Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD) |
RECRUITING | PHASE3 |
| NCT06888492 |
To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD) |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT06875245 |
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals |
RECRUITING | PHASE4 |
| NCT06859515 |
A Long-term Follow up Study of EXG102-031 in Participants With wAMD |
RECRUITING | |
| NCT06556368 |
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06518512 |
Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet AMD Patients |
ACTIVE_NOT_RECRUITING | |
| NCT05727397 |
Efficacy and Safety of RC28-E Versus Aflibercept |
RECRUITING | PHASE3 |
