The first patient has been enrolled in Myra Vision’s ADAPT clinical study evaluating the Calibreye TGT Surgical System in glaucoma patients. The company considers this milestone a significant advancement in its U.S. regulatory pathway after last summer’s 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. David Godfrey, of the Glaucoma Associates of Texas. “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 Myra Vision advisor Ike Ahmed, M.D., director of the Alan S. Crandall Center for Glaucoma Innovation, John A. Moran Eye Center in Utah. “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,” Myra Vision President/CEO Robert Chang stated. “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 available for sale.

A privately held portfolio company of Shifamed LLC, Myra Vision is developing a new aqueous shunt designed to allow safe personalized IOP control, based on specific patient needs while also reducing complexity and complication rates.

Founded by serial entrepreneur Amr Salahieh, Shifamed LLC is a highly specialized medical innovation hub developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path to allow patients to lead longer, healthier lives.

Reference
¹ Sheybani A, et al. Ophthalmol Ther. 2020;9(1):1-14.