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.
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.
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.
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.
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's Axpaxli met its primary endpoint in the SOL-1 Phase 3 trial, showing superior vision maintenance compared to aflibercept in wet AMD patients. The company plans to pursue FDA approval based on the results.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07482176 |
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS) |
RECRUITING | PHASE3 |
| NCT07317934 |
Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR) |
RECRUITING | PHASE3 |
| NCT06856577 |
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06704009 |
NT-101 Topical Ophthalmic Solution in Patients With Wet AMD |
COMPLETED | PHASE1/PHASE2 |
| NCT05210803 |
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD |
ENROLLING_BY_INVITATION | |
| NCT04704921 |
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT01339949 |
Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV) |
WITHDRAWN | NA |
| NCT01310686 |
Genetics Study of Wet Age-Related Macular Degeneration (AMD) Non-Responders to Vascular Endothelial Growth Factor (VEGF) Therapy |
UNKNOWN | |
| NCT01016873 |
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD |
COMPLETED | PHASE2 |
| NCT00804934 |
Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis |
COMPLETED |
