USFDAAug 3, 2026, 07:03 AM
Ocular AXPAXLI Wet AMD NDA on Track for Q4 2026; Q2 Net Loss $(78.8)M
AI Summary
Ocular Therapeutix announced that its AXPAXLI NDA submission for wet AMD is on track for Q4 2026, following positive Type C meeting minutes from the U.S. FDA confirming the SOL-1 trial as sufficient. The company plans to use the 505(b)(2) pathway, which could accelerate the review timeline by up to 60 days. A new post-hoc analysis of SOL-1 data demonstrated up to an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI. For Q2 2026, Ocular reported total net revenue of $13.5 million and a net loss of $(78.8) million, with a cash balance of $598.6 million providing a runway into 2028.
Key Highlights
- AXPAXLI NDA submission for wet AMD is on track for Q4 2026.
- FDA Type C meeting minutes confirmed SOL-1 trial data is sufficient for NDA submission.
- NDA submission will follow the 505(b)(2) pathway, potentially accelerating review by up to 60 days.
- New post-hoc SOL-1 analysis shows up to an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI.
- Q2 2026 total net revenue was $13.5 million, flat compared to Q2 2025.
- Q2 2026 net loss was $(78.8) million, or $(0.35) per share.
- Cash balance of $598.6 million as of June 30, 2026, provides runway into 2028.
- Commercial readiness is accelerating for a potential AXPAXLI launch in 2027.
Price Impact
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