MeiraGTx presents bota-vec filing plans targeting potential US, EU approvals in 2027
MGTX•MeiraGTx plans to file for European marketing authorization for bota-vec in December 2026 and expects to complete a US biologics license application in Q1 2027, targeting potential approvals in 2027. The Phase 3 trial missed its primary endpoint but showed significant improvements on secondary vision measures.
1. Bota-vec filing plans
MeiraGTx plans to submit a European marketing application for bota-vec in December 2026 and expects to complete a US biologics license application in the first quarter of 2027. The company is targeting potential US and European approvals in 2027 for the X-linked retinitis pigmentosa therapy. Its Phase 3 trial missed statistical significance on the primary endpoint but showed significant improvements across secondary measures of vision.
2. Other program timelines
MeiraGTx said AAV-AQP1 has completed pivotal Phase 2 enrollment for radiation-induced xerostomia, with a potential biologics license application filing in mid-2027. Parkinson’s therapy AAV-GAD is Phase 3-ready, with a potential filing in 2028.
