-+ 0.00%
-+ 0.00%
-+ 0.00%

Ocular Therapeutix Intends To Submit An Fda New Drug Application For Axpaxli For Wet Age-related Macular Degeneration Following Year One Data, If Positive, From Its Ongoing SOL-1 Phase 3 Trial For Which Data Are On Track For Q1 Of 2026

Benzinga·12/08/2025 12:02:34
Listen to the news
  • Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive
  • SOL-1 topline data remain on track for 1Q 2026
  • Ocular plans to leverage the 505(b)(2) regulatory pathway for new drug approvals which has the potential to shorten the review timeline for AXPAXLI
  • If approved, AXPAXLI could be the first TKI to be commercialized in wet AMD, with a potential superiority label and best-in-class durability