DME commonly refers to diabetic macular edema, a vision-threatening complication of diabetes caused by fluid accumulation in the macula. It results from diabetes-related retinal vascular dysfunction and is a major cause of visual impairment. Management often includes anti-VEGF-based therapy and metabolic risk control.
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.
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.
Zydus Lifesciences launched ANYRA, India's first indigenously developed aflibercept biosimilar, on February 19, 2026, following an agreement with Regeneron Pharmaceuticals and Bayer for multiple ophthalmic indications.
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
Zydus Lifesciences plans to launch Semaglutide injection in India after patent expiry and introduced ANYRA, India's first indigenous Aflibercept biosimilar. The USFDA cleared the company's Ahmedabad injectable facility with zero observations.
The FDA has approved an expanded label for Sandoz's aflibercept biosimilar Enzeevu to include multiple retinal indications beyond its original approval for neovascular age-related macular degeneration. The product is expected to launch in the US in Q4 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07459829 |
Study of CU06-1004 in Patients With Daibetic Macular Edema |
NOT_YET_RECRUITING | PHASE2 |
| NCT07449936 |
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME |
RECRUITING | PHASE3 |
| NCT07449923 |
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME |
RECRUITING | PHASE3 |
| NCT07328776 |
AI vs. Physician for Anti-VEGF Decision-Making: An RCT |
NOT_YET_RECRUITING | NA |
| NCT07199777 |
A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients |
NOT_YET_RECRUITING | PHASE2 |
| NCT06900868 |
The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial |
NOT_YET_RECRUITING | NA |
| NCT06875544 |
Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation |
NOT_YET_RECRUITING | NA |
| NCT04119921 |
Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab |
COMPLETED | PHASE2/PHASE3 |
| NCT00105404 |
Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation |
COMPLETED | PHASE3 |
