1. GKOS received FDA Day 74 notification; NDA for Epioxa accepted for review. 2. Phase 3 trials hit primary endpoints; data shows favorable safety and efficacy. 3. Epioxa offers non-invasive keratoconing treatment; uses novel drug formulation. 4. FDA review goal set to Oct 20, 2025; stock up 25% in premarket.
The NDA acceptance and positive Phase 3 results reinforce investor confidence and mirror previous successful product milestones such as Photrexa. The premarket surge further validates market optimism.
This news marks a critical regulatory milestone with strong trial data, offering long-term growth potential and directly impacting GKOS’s market outlook.
While the immediate premarket jump is notable, significant revenue and market impact will materialize post-FDA approval. Historical biotech cases show sustained gains after successful regulatory reviews.