Myra Vision announced that it has initiated its first-in-human clinical study of the Calibreye™ System, a next generation glaucoma drainage device with titratable outflow control designed to achieve optimal reduction of intraocular pressure (IOP) for moderate to severe glaucoma patients. The prospective, non-randomized open-label feasibility study aims to evaluate the clinical procedure, safety, and overall performance of the Calibreye System in open angle glaucoma patients.
The Calibreye System is engineered to put outflow control in the hands of glaucoma specialists, giving them the opportunity to provide personalized therapy while minimizing complications. Once implanted, the Calibreye shunt is designed to allow non-invasive in-office increases or decreases in outflow as a patient's individual treatment needs change.
"Managing glaucoma remains increasingly challenging as the condition progresses to moderate and severe stages," commented Dr. Rohit Varma, Founding Director of Southern California Eye Institute in Los Angeles, CA. "Unlike other glaucoma drainage devices, the titratable outflow of the Calibreye System has the potential to achieve personalized optimal IOP in our patients, with simple, in-office adjustments. I believe this is a transformative advance in the management of our patients with moderate and severe glaucoma."
Glaucoma, a leading cause of irreversible blindness, affects an estimated 66M people worldwide.1 More than one third of 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.
"I am pleased to be a part of these initial cases and am impressed by the early performance of the Calibreye System," stated Dr. Iqbal Ike K. Ahmed, Director, Alan S. Crandall Center for Glaucoma Innovation, John A. Moran Eye Center and Director, Glaucoma & Advanced Anterior Segment Surgery (GAASS) Fellowship, University of Toronto. "In my opinion, the Calibreye System was implanted using a familiar and established technique. I look forward to following these patients to observe the performance of the implant and the ability to adjust outflow, if needed, over time."
"This first-in-human experience marks an important milestone as Myra transitions to a clinical stage company," stated Robert Chang, President and Chief Executive Officer of Myra Vision. "I would like to thank the entire team for their seamless execution and our clinical advisors for their expertise in guiding these initial cases. We look forward to gaining additional insights as we advance our goal of bringing personalized glaucoma care to the surgical armamentarium for patients with moderate to severe glaucoma."
Read the full press release from Myra Vision.