FDA Alignment Boosts Wet AMD Treatment Path - Summary - MDSpire

FDA Alignment Boosts Wet AMD Treatment Path

Ocular Therapeutix plans Q4 NDA filing for AXPAXLI

  • July 7, 2026

  • 3 min

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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:

Original Source(s)

FDA Alignment Boosts Wet AMD Treatment Path

  • July 7, 2026

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