Ocular Therapeutix Aligns with FDA for AXPAXLI NDA in Q4 2026
Ocular Therapeutix announced FDA alignment for its AXPAXLI New Drug Application (NDA) in wet Age-related Macular Degeneration (AMD), with submission planned for Q4 2026. The NDA will be based on SOL-1 Week 52 efficacy and safety data, combined with interim SOL-R safety data, aiming to reach over 300 patients of safety data. The company also streamlined its diabetic retinopathy program to prioritize a single Phase 3 trial, HELIOS-3, evaluating Q12M dosing of AXPAXLI. The SOL-R trial's efficacy data is no longer part of the initial NDA submission, allowing Ocular to extend masking and evaluate new secondary endpoints, including superiority over aflibercept (8mg) at Week 96, with topline results now expected in Q1 2028.
Key Highlights
- AXPAXLI NDA for wet AMD submission planned for Q4 2026 following FDA alignment.
- NDA to be based on SOL-1 Week 52 efficacy/safety and interim SOL-R safety data.
- Interim SOL-R safety analysis in Q4 2026 to achieve >300 patient-years of safety data.
- SOL-R efficacy data removed from initial NDA; trial extended to Week 96 for new secondary endpoints.
- New SOL-R secondary endpoint: superiority vs aflibercept (8mg) at Week 96.
- SOL-R topline results now expected in Q1 2028.
- Diabetic retinopathy program streamlined to single Phase 3 trial, HELIOS-3 (Q12M dosing).
- NDA to be submitted via 505(b)(2) pathway, potentially accelerating review by up to 60 days.
Price Impact
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