Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma
Shots:
- Myra Vision received the US FDA conditional IDE approval to initiate its ADAPT study evaluating Calibreye Titratable Glaucoma Therapy (TGT) surgical system for glaucoma
- The IDE trial will evaluate the safety and efficacy of Calibreye TGT surgical system in ~70 refractory glaucoma pts with 12mos. primary effectiveness endpoint
- Calibreye System allows ophthalmologists to control aqueous outflow for personalized therapy with reduced complications, using an implanted shunt that allows slit lamp-based outflow adjustments as patient needs change
Ref: Myra Vision | Image: Myra Vision | Press Release
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