other_material
confidence high
sentiment neutral
materiality 0.55
Ocular Therapeutix updates AXPAXLI trials: SOL-1 topline Q1 2026, SOL-R H1 2027; initiates NPDR Phase 3
OCULAR THERAPEUTIX, INC
- SOL-1 Phase 3 wet AMD trial topline results expected Q1 2026; retention >95%, rescue events >95% meet criteria, no new safety signals.
- SOL-R Phase 3 wet AMD trial enrollment completed, randomization ongoing; topline results expected H1 2027.
- Plans to initiate SOL-X long-term extension trial following SOL-1/SOL-R; subjects receive AXPAXLI every 24 weeks for 3 years.
- Initiates Phase 3 NPDR program with HELIOS-2 (432 subjects) and HELIOS-3 (930 subjects); FDA SPA agreement for HELIOS-2 design.
- Received notice of allowance from USPTO for patent covering treating ocular diseases with AXPAXLI; expiration expected 2044.
item 8.01