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.
Recent studies in retinitis pigmentosa showed mixed results for gene and optogenetic therapies. UGX-201 and MCO-010 were associated with visual acuity improvements, while AAV8.hPDE6A showed no significant functional gains at 1 year.
Ray Therapeutics received EMA PRIME designation for its RTx-015 optogenetic gene therapy for retinitis pigmentosa, following recent FDA RMAT status. The company also appointed Michael Murtagh as Chief Regulatory Officer to support global development.
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.
An observational study in Documenta Ophthalmologica found the MLSDT showed reliability above 0.50 in advanced retinitis pigmentosa and correlated with visual acuity, visual fields and patient-reported outcomes. The test is being used as a secondary endpoint in the phase 2b/3 RESTORE trial of MCO-010.
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.
Outlook Therapeutics conducted a Type A meeting with the FDA to discuss the December 30, 2025 Complete Response Letter for ONS-5010/LYTENAVA™, focusing on substantial evidence of effectiveness and potential regulatory paths forward.
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.
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.
Ocular Therapeutix announced positive topline results from SOL-1, its Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting primary and durability endpoints with high statistical significance.
