Clinical Report: FDA Alignment Boosts Wet AMD Treatment Path

Overview

Ocular Therapeutix plans to submit a New Drug Application for AXPAXLI in wet AMD by Q4 2026, based on Phase 3 SOL-1 efficacy and interim SOL-R safety data.

Background

Wet age-related macular degeneration (AMD) is a leading cause of vision loss in older adults, necessitating effective treatment options. Regulatory strategies that streamline the approval process are crucial for timely access to innovative treatments.

Data Highlights

No numerical data available in the source material.

Key Findings

• Ocular Therapeutix plans to submit a New Drug Application for AXPAXLI in Q4 2026.
• The submission will be based on Phase 3 SOL-1 efficacy data and interim SOL-R safety data.
• AXPAXLI is a bioresorbable intravitreal hydrogel incorporating axitinib, targeting wet AMD and diabetic retinal disease.
• The FDA-aligned plan is seen as a pivotal milestone for Ocular Therapeutix.
• Topline data from the SOL-R trial are now expected in Q1 2028.
• A new secondary endpoint will evaluate AXPAXLI's efficacy compared to aflibercept at Week 96.

Clinical Implications

The planned NDA submission for AXPAXLI reflects ongoing efforts to enhance treatment options for wet AMD.

Conclusion

The FDA alignment for AXPAXLI represents a significant step towards advancing treatment for wet AMD.

Related Resources & Content

1. Ocular Therapeutix, Source, 2026 -- FDA Alignment Boosts Wet AMD Treatment Path
2. Retinal Physician, Source, 2008 -- Triple Therapy for Wet AMD Shows Impressive Results
3. The Ophthalmologist, Source, 2026 -- The Next Frontier in Wet AMD
4. Ophthalmology Management, Source, 2007 -- Following Through on Your AMD Diagnosis
5. PubMed, Source, 2025 -- Age-Related Macular Degeneration Preferred Practice Pattern®
6. Nature, Source, 2025 -- Aflibercept 8 mg treat-and-extend pathway for the treatment of neovascular age-related macular degeneration
7. the ophthalmologist — Expanding the Therapeutic Landscape in Wet Age-related Macular Degeneration
8. Age-Related Macular Degeneration Preferred Practice Pattern® - PubMed
9. Aflibercept 8 mg treat-and-extend pathway for the treatment of neovascular age-related macular degeneration: guidance from a UK expert panel
10. Ocular Therapeutix™ Reports Positive Results from Landmark