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High materiality7/10

Ocular maps NDA plan for AXPAXLI with FDA alignment

Jun 17, 2026, 11:16 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

FDA-aligned NDA pathway and single-trial strategy reduce execution risk; positive trial signals from SOL-1 and a clearer path to potential approval signal a re-rating, despite longer lead times to 2026–2028.

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Ocular Therapeutix plans to submit an NDA for AXPAXLI in wet age-related macular degeneration in Q4 2026, aligned with FDA guidance on a single-trial filing using SOL-1 data. The filing will exclude SOL-R efficacy data, while preliminary SOL-1 results were highly significant (p=0.0006). The SOL-R redesign shifts topline results to 1Q2028 and expands endpoints to differentiate from aflibercept therapies, with HELIOS-3 central to diabetic retinopathy development.

NDA for AXPAXLI in wet AMD targeted for Q4 2026, per FDA-aligned plan.
NDA relies on SOL-1 data; SOL-R data excluded from NDA package.
SOL-R topline delayed to 1Q2028; masking extended to Week 96 with new endpoints.
HELIOS-3 program to be the single global registrational study for diabetic retinopathy.

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