Company’s first-of-its-kind titratable glaucoma therapy system aims to optimize intraocular pressure (IOP) reduction for patients with moderate to severe glaucoma
- Results demonstrate significant IOP and medication reduction compared to baseline
CAMPBELL, Calif., March 3, 2025 /PRNewswire/ -- Myra Vision, a Shifamed portfolio company, announced today that the 3-month results from its feasibility study were presented this past weekend by Dr. Arsham Sheybani, Associate Professor, Ophthalmology and Visual Sciences at the Washington University School of Medicine, during the American Glaucoma Society (AGS) annual meeting in Washington, DC. The prospective, non-randomized open-label study aims to evaluate the feasibility, safety, and efficacy of the company’s Calibreye Titratable Glaucoma Therapy™ (TGT) Surgical System in open angle glaucoma patients.
The multi-center international study enrolled 43 patients with moderate to late-stage disease, of which 33 patients had greater than 3 months of follow-up, at four sites in three countries. Dr. Keith Barton, a Consultant Ophthalmologist and Glaucoma Specialist at Moorfields Eye Hospital and Professor of Ophthalmology at University College London Institute of Ophthalmology, is the medical monitor for the trial.
The Calibreye System is engineered to put aqueous outflow control in the hands of ophthalmologists, allowing them to provide personalized therapy with minimal complications in the tried-and-true form of an aqueous shunt. Once implanted, the Calibreye shunt is designed to allow in-office outflow adjustments as individual patient needs change.
The 3-month clinical trial results presented demonstrated:
44.9% intraocular pressure (IOP) reduction compared to baseline, with an average IOP of 12.1 mmHg
88% of patients were medication-free, with 100% of patients on less than or equal to the number of meds at baseline
Over 96% mean medication reduction compared to baseline, equating to a mean reduction of over 3 medications per patient
No patients required bleb needling procedures
- 100% of devices implanted successfully, 100% of titrations completed successfully with an average of 2.2 titrations per patient
“I am encouraged by these early patient results which provide a good indication of the Calibreye Shunt performance,” stated Dr. Sheybani. “This has the potential to be a novel advancement that will allow us to titrate IOP control in a minor procedure room or in-office setting by laser for our patients suffering from moderate and severe glaucoma. I look forward to following these patients and am excited for the opportunity this technology may offer for improving patient care.”
In addition, Dr. Rohit Varma, Founding Director of Southern California Eye Institute in Los Angeles, CA presented a poster summarizing titration outcomes of the Calibreye System in the feasibility study at the conference.
“We are extremely pleased with these initial three-month results,” said Robert Chang, President and Chief Executive Officer of Myra Vision. “These early patient outcomes provide support for the Calibreye System and the clinical advantages being provided through post operative titration of an aqueous shunt that can be customized to the needs of each patient. We look forward to continuing to learn and optimize treatment solutions, particularly in regard to outflow management, and are grateful to our clinical investigators for their support and contributions.”
Glaucoma, a leading cause of irreversible blindness, affects an estimated 80M people worldwide.1 Approximately half of these patients have moderate to severe glaucoma, which requires significant reductions in IOP. Traditionally, these glaucoma patients have been treated with surgery, including trabeculectomy and tube shunt implants. Recent advances in less invasive surgical devices offer simpler and safer treatment options. While these devices have demonstrated an improvement in complication rates, achieving the IOP reductions necessary for the moderate to severe glaucoma patient population remains challenging.
The company plans to increase enrollment and add clinical sites as part of this feasibility study in preparation for its pivotal study IDE submission. 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.
Media Contact:
Charlene Herndon
SPRIG Consulting1 2024 Market Scope Glaucoma Surgical Device
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SOURCE Myra Vision, Inc.
