Myra Vision Receives FDA Approval For Glaucoma Study
Summary by Medical Device News Magazine
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2 Articles
Myra Vision Secures FDA Approval to Initiate US-Based IDE Study in Glaucoma
Myra Vision announced today that the FDA has issued a conditional approval letter for its investigational device exemption (IDE) application, allowing the company to initiate the ADAPT study. The prospective, nonrandomized, open-label trial will evaluate the safety and effectiveness of the Calibreye Titratable Glaucoma Therapy (TGT) Surgical System in up to 70 refractory glaucoma patients, with a 12-month primary effectiveness endpoint. “Lowerin…
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