OCUL Ocular Therapeutix

axitinib · NCT05327686 registry update

countries: {'total_sites': 328, 'us_sites': 323} → {'total_sites': 348, 'us_sites': 342}

axitinib · NCT04337970 registry update

primary_outcomes: ['Phase Ib: Recommended dose of talazoparib in combination with standard-dose axitinib', 'Phase Ib: Dose Limiting Toxicity', 'Phase II: Objective Response Rate'] → ['Phase Ib: Recommended Dose of Talazoparib in Combination With Standard-dose Axitinib', 'Phase Ib: Number of Dose Limiting Toxicity', 'Phase II: Objective Response Rate']

OCUL: AXPAXLI NDA submission planned for Q4 2026 in wet AMD

FDA Type C meeting minutes confirm SOL-1 Week 52 data plus interim SOL-R safety and confirmatory evidence are sufficient for NDA submission. Pre-NDA meeting is scheduled for Q3 2026 and the 505(b)(2) pathway is expected to shorten review by up to 60 days. SOL-R efficacy data are no longer required for the NDA.

Ocular Therapeutix plans AXPAXLI NDA submission for wet AMD in Q4 2026

FDA alignment reached via May 2026 Type C meeting allows NDA under 505(b)(2) pathway based on SOL-1 Week 52 data plus interim SOL-R safety data. SOL-R efficacy data are removed from the submission plan, with masking extended to Week 96 and topline now expected in Q1 2028. Pre-NDA meeting scheduled for Q3 2026 and interim SOL-R safety analysis planned for Q4 2026 to meet >300-patient safety requirement.

OCUL: SOL-1 Phase 3 topline data for AXPAXLI in wet AMD expected February 2026

The company announced that SOL-1 Phase 3 superiority trial results for AXPAXLI in wet AMD will be presented at the 49th Macula Society Annual Meeting (Feb 25-28, 2026). Pending positive results, Ocular plans to submit an NDA based on the single SOL-1 52-week dataset under the 505(b)(2) pathway.

OCUL updates SOL-1 Phase 3 wet AMD trial timeline to Q1 2026

The 8-K confirms SOL-1 Phase 3 wet AMD trial topline readout is now expected in Q1 2026 after Week 52 visits, and SOL-R topline in H1 2027. It also discloses SPA agreement for HELIOS-2 NPDR trial and plans to initiate two Phase 3 NPDR trials (HELIOS-2 and HELIOS-3).