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Ocular Therapeutix Completes Pre-NDA Meeting with FDA for Axpaxli in Wet AMD
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Fusion42 · 17 September 2026 · Fusion42 review
Ocular Therapeutix completed a pre-NDA meeting with the FDA for Axpaxli in wet AMD, keeping on track for a Q4 2026 NDA submission. The application will include Phase 3 SOL-1 efficacy and safety data, interim Phase 3 SOL-R safety data, and confirmatory evidence supporting repeat dosing.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 16 Sep 2026 and 17 Sep 2026.
◆ ◆ The Wire takeaway
Your biotech startup targeting retinal diseases should prepare for a stricter regulatory timeline as FDA signals confidence in data requirements for wet AMD therapies. File your pivotal trial plans to align with evolving FDA expectations on repeat-dosing data this quarter.
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2 sources · first reported 16 Sep 2026 · latest 17 Sep 2026
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