First Patient Treated in Myra Vision's U.S. ADAPT Clinical Study for Glaucoma
- Initial case conducted by Dr. David Godfrey at Glaucoma Associates of Texas
- The IDE study will evaluate the safety and effectiveness of the company's Calibreye™ Titratable Glaucoma Therapy™ (TGT) Surgical System
CAMPBELL, Calif., Jan. 26, 2026 /PRNewswire/ -- Myra Vision, a Shifamed portfolio company, today announced the first patient enrolled in its ADAPT clinical study evaluating the Calibreye™ TGT Surgical System in patients with glaucoma. This milestone represents a significant advancement in Myra Vision's U.S. regulatory pathway, following the company's August 2025 announcement of the U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application.
"We are thrilled to participate in the ADAPT trial and to have treated our first patient with the Calibreye System," said Dr. Godfrey. "The potentially groundbreaking Calibreye System is the first adjustable glaucoma shunt in the United States, aiming to enable clinician-directed postoperative adjustment to support individualized intraocular pressure (IOP) management."
The ADAPT trial is a prospective, multicenter, nonrandomized open-label study that will enroll up to 70 refractory glaucoma patients with a 12-month primary effectiveness endpoint. The clinical investigation will evaluate the safety and effectiveness of the company's titratable glaucoma therapy system, designed to optimize IOP reduction in patients undergoing glaucoma surgery. Once implanted, the Calibreye aqueous shunt is designed to enable slit lamp-based outflow adjustments as individual patient requirements evolve over time.
"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 U.S. clinical study," stated Ike Ahmed, M.D., Director of the Alan S. Crandall Center for Glaucoma Innovation, John A. Moran Eye Center, Utah, United States, and a Myra Vision advisor. "Titratable glaucoma therapy has the potential to provide a meaningful solution for the significant number of these patients in need."
The leading cause of irreversible blindness, glaucoma affects an estimated 80M people worldwide.1 There is no cure for glaucoma, so patients and their caregivers seek to reduce disease progression through IOP control. Traditional glaucoma surgery, including trabeculectomy and tube shunt implants, and more recently developed less invasive surgical devices, do not offer adjustability to meet individual clinical needs.
"We are excited to have enrolled the first patient in our ADAPT clinical study. This is a significant accomplishment for our organization, and an important step towards delivering the Calibreye System to physicians and patients," commented Robert Chang, President and Chief Executive Officer of Myra Vision. "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 personalized IOP control provided by Calibreye will offer physicians greater confidence to address the needs of these underserved patients."
The Calibreye System is for investigational use only and is not for sale in the U.S. or outside the U.S.
About Myra Vision, Inc.
Myra Vision, a privately held portfolio company of Shifamed LLC, is developing a new aqueous shunt that is designed to allow safe personalized IOP control, based on the specific needs of the patient, while also reducing complexity and complication rates. To learn more about Myra Vision, please visit www.myravision.com.
About Shifamed, LLC.
Founded by serial entrepreneur Amr Salahieh, Shifamed LLC is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.
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1 Sheybani A, et al. Ophthalmol Ther. 2020;9(1):1-14.
SOURCE Myra Vision, Inc.
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