Ocular Therapeutix says FDA aligns on AXPAXLI wet AMD NDA plan for Q4 2026 submission

Ocular Therapeutix Inc

Ocular Therapeutix Inc

OCUL

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  • 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.


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