FDA Alignment Boosts Wet AMD Treatment Path
Ocular Therapeutix plans Q4 NDA filing for AXPAXLI
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Ocular Therapeutix plans to submit a New Drug Application for AXPAXLI in wet AMD by Q4 2026, based on Phase 3 SOL-1 data.
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The submission will follow a Type C meeting with the FDA and utilize the 505(b)(2) pathway to potentially shorten the review timeline.
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AXPAXLI is a bioresorbable intravitreal hydrogel incorporating axitinib, targeting wet AMD and diabetic retinal disease.
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Ocular aims to hold a pre-NDA meeting with the FDA in Q3 2026 to confirm submission details and expects AXPAXLI to reach patients in 2027.
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The company is amending the SOL-R trial and plans to evaluate AXPAXLI against aflibercept in a new secondary endpoint at Week 96.
