Ocular Therapeutix secures FDA alignment on 505(b)(2) NDA plan for AXPAXLI in wet AMD

 

targeting Q4 2026 submission

• NDA will rely on SOL-1 efficacy data plus interim safety data from the SOL-R trial.
• Company agreed with FDA on a new superiority endpoint versus aflibercept for SOL-R efficacy assessment.
• SOL-R efficacy data timing pushed back, with key readout now expected in 2028 under revised plan.
• Plan includes a streamlined single Phase 3 HELIOS-3 trial in diabetic retinopathy instead of multiple studies.

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