Objective:
To outline Ocular Therapeutix's plans for submitting a New Drug Application for AXPAXLI in wet AMD.
Approach:
- FDA Meeting: Ocular Therapeutix held a Type C meeting with the FDA in May 2026 to discuss the submission.
- NDA Submission: The company plans to submit the NDA under the 505(b)(2) pathway in Q4 2026.
- Clinical Trials: The submission will be based on Phase 3 SOL-1 efficacy and interim SOL-R safety data.
Key Findings:
- AXPAXLI is a bioresorbable intravitreal hydrogel incorporating axitinib.
- SOL-1 data will form the efficacy basis for the NDA submission.
- An interim SOL-R safety analysis will include over 300 patients.
Interpretation:
Limitations:
- SOL-R efficacy data will not be included in the NDA submission.
- Topline data for SOL-R are now expected in Q1 2028.
Conclusion:
Sources:
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