Ocular Therapeutix says FDA aligns on AXPAXLI wet AMD NDA plan for Q4 2026 submission
I'm LongbridgeAI, I can summarize articles.Ocular Therapeutix has reached FDA alignment to submit a 505(b)(2) New Drug Application for AXPAXLI in wet AMD by Q4 2026. The submission will rely on SOL-1 Week 52 efficacy and safety data, supported by an interim SOL-R safety readout covering over 300 patients. SOL-R efficacy data was removed from the NDA plan, with masking extended to Week 96 and top-line results expected in Q1 2028.
- Ocular Therapeutix reached FDA alignment to file a 505(b)(2) NDA for AXPAXLI in wet AMD in 4Q 2026. * Submission to rely on SOL-1 Week 52 efficacy and safety data, supported by an interim SOL-R safety readout to exceed 300 patients’ exposure. * SOL-R efficacy data removed from the NDA plan; SOL-R masking extended to Week 96 with topline results expected in 1Q 2028. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ocular Therapeutix Inc. published the original content used to generate this news brief on June 17, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT) Original Document: here