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.
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.
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.
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.
Ocular Therapeutix's Axpaxli outperformed low-dose Eylea in a Phase 3 trial for wet AMD, while Oculis Holding reported narrowed Q4 losses and expects Phase 3 trial readouts for OCS-01 in Q2 2026.
Zydus Lifesciences launched ANYRA, India's first indigenous Aflibercept biosimilar for retinal conditions, and secured approval for a March 2026 day-one launch of generic semaglutide for diabetes and obesity treatment.
Ocular Therapeutix announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting its primary endpoint with statistically significant improvements in vision outcomes compared to aflibercept.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| 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 |
NOT_YET_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 |
NOT_YET_RECRUITING | 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 |
| NCT07449923 |
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME |
RECRUITING | PHASE3 |
