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.
Kodiak Sciences' experimental drug Zenkuda achieved 62.5% response rate in diabetic retinopathy trial with 85% reduction in sight-threatening complications. The company plans to accelerate FDA submission while preparing for wet AMD study readout in Q3 2026. Shares surged 68.6% following the positive late-stage results.
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.
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.
Regeneron has consistently increased revenue over 35 years with blockbuster products like Dupixent and Eylea HD, while maintaining over a dozen phase 3 clinical trial candidates across multiple therapeutic areas.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07389577 |
A Study to Compare JL14002 to Lucentis® in Subjects With Wet Age-related Macular Degeneration (wAMD) |
COMPLETED | PHASE3 |
| NCT07338513 |
User-centric Study of Patients' Receptiveness Towards the Web-based Automated Vision Impairment Gaze-tracking Analysis Systems |
NOT_YET_RECRUITING | |
| NCT07178249 |
Evaluating the Safety and Preliminary Efficacy of EXG202 Gene Therapy for Neovascular AMD |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06952452 |
Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD) |
RECRUITING | PHASE3 |
| NCT06888492 |
To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD) |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT06875245 |
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals |
RECRUITING | PHASE4 |
| NCT06859515 |
A Long-term Follow up Study of EXG102-031 in Participants With wAMD |
RECRUITING | |
| NCT06556368 |
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06518512 |
Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet AMD Patients |
ACTIVE_NOT_RECRUITING | |
| NCT05727397 |
Efficacy and Safety of RC28-E Versus Aflibercept |
RECRUITING | PHASE3 |
