Myra Vision has enrolled the first patient in the ADAPT clinical trial assessing its Calibreye Titratable Glaucoma Therapy (TGT) surgical system in the US, following recent approval of its investigational device exemption by the Food and Drug Administration (FDA).
The non-randomised open-label, multi-centre, prospective study is designed to evaluate the effectiveness and safety of the Calibreye system in people with refractory glaucoma.
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It will enrol up to 70 patients with refractory glaucoma and has a 12-month primary effectiveness endpoint.
The investigation focuses on Myra Vision’s titratable therapy system, which is designed for optimising intraocular pressure (IOP) reduction for those undergoing glaucoma surgery.
Once implanted, the Calibreye shunt enables slit lamp-based outflow adjustments as patient requirements change over time.
Myra Vision adviser Ike Ahmed said: “Having been involved in the development of this device for many years, it is incredibly rewarding to see our research come to fruition and now move into the US clinical study.
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By GlobalData“Titratable glaucoma therapy has the potential to provide a meaningful solution for the significant number of these patients in need.”
Myra Vision president and CEO Robert Chang said: “We are excited to have enrolled the first patient in our ADAPT clinical study. This is a significant accomplishment for our organisation, and an important step towards delivering the Calibreye system to physicians and patients.
“Subconjunctival filtration procedures like Calibreye are currently being evaluated in a small percentage of eligible moderate to advanced glaucoma patients who require significant pressure reduction. The personalised IOP control provided by Calibreye will offer physicians greater confidence to address the needs of these underserved patients.”
The system is currently designated for investigational use and is not approved for commercial sale in the US or other countries.
