Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
Axpaxli (OTX-TKI) met its primary endpoint in the SOL-1 Phase 3 trial, demonstrating superiority over aflibercept in preserving visual acuity in wet AMD patients at week 36. A single injection of the intravitreal hydrogel led to higher rescue-free rates and better fluid control, supporting potential for reduced treatment burden. Ocular Therapeutix plans to submit a New Drug Application to the FDA.
Ocular Therapeutix stock surged 30% in premarket trading as the company prepared to release topline Phase 3 data for AXPAXLI in wet AMD. The SOL-1 trial results will be presented at the Macula Society meeting later in February. The company plans to file for FDA approval using one-year data if results are favorable.
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.
EyePoint's DSMC recommended continuing its Phase 3 wet AMD trials without protocol changes after a third review. Topline data for LUGANO are expected mid-2026, with LUCIA shortly after. The company ended 2025 with $300 million in cash and a runway into Q4 2027.
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.
| 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 |
| 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 | |
| NCT00403026 |
Intravitreal Bevacizumab for Retinal Disorders |
UNKNOWN | NA |
