Diabetic macular edema is an ocular complication of diabetes caused by disruption of retinal vascular barriers and fluid accumulation in the macula. It is a major cause of vision loss in people with diabetes and often requires ophthalmologic treatment such as anti-VEGF therapy. Risk increases with diabetes duration and inadequate metabolic control.
Biocon's Yesafili, an interchangeable aflibercept biosimilar, is now available in the U.S., while Zydus Lifesciences launched Anyra in India. Both aim to treat retinal diseases such as diabetic macular edema. Biocon plans further launches in the UK and other markets, as competition intensifies.
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.
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.
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.
The CONDOR randomized clinical trial found brolucizumab better preserved visual acuity than panretinal photocoagulation in proliferative diabetic retinopathy at week 54. Brolucizumab also reduced vision-threatening complications and center-involved diabetic macular edema events, while showing more intraocular inflammation.
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.
Two studies of older adults with type 2 diabetes linked diabetic retinal disease with higher dementia risk. DME and more severe diabetic retinopathy were associated with higher all-cause and vascular dementia risk, but not consistently with Alzheimer’s disease.
The FDA approved updated labeling for Vabysmo to allow extended treatment of macular edema following retinal vein occlusion beyond six months. The label update removes the prior 6-month restriction and retains monthly 6 mg intravitreal dosing.
The FDA approved an updated Vabysmo label for macular edema following retinal vein occlusion beyond six months. The decision extends treatment based on data showing visual acuity gains and central subfield thickness reductions maintained through week 72.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07753616 |
South Asian Patients With Diabetic Macular Oedema Treated With Faricimab Assessing the Efficacy, Durability, and Safety (SEAFAR Study) |
NOT_YET_RECRUITING | PHASE4 |
| NCT07604545 |
A Study to Assess the Use of Artificial Intellignce to Predict Eye Treatment Changes in Adult Participants With Diabetic Macular Edema |
NOT_YET_RECRUITING | |
| NCT07567898 |
Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates |
NOT_YET_RECRUITING | NA |
| NCT07553429 |
A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated |
RECRUITING | PHASE1/PHASE2 |
| NCT07501052 |
Study of the SCD411 Prefilled Syringe for Treating Adults With Wet Age-Related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema, or Diabetic Retinopathy |
COMPLETED | PHASE2 |
| NCT07489131 |
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema |
RECRUITING | PHASE3 |
| NCT07481500 |
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Trial of Pain, Procedure Time, Patient Satisfaction, and Safety |
NOT_YET_RECRUITING | NA |
| NCT07459829 |
Study of CU06-1004 in Patients With Daibetic Macular Edema |
NOT_YET_RECRUITING | PHASE2 |
| NCT07458061 |
Kamuvudine-9 (K9) in Diabetic Macular Edema |
RECRUITING | PHASE1/PHASE2 |
| NCT07449936 |
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME |
RECRUITING | PHASE3 |
