The system is a next generation aqueous shunt therapy for patients with moderate to severe glaucoma.
Myra Vision, a Shimafed portfolio company, has announced its first-in-human clinical study of the Calibreye™ System.
According to a press release from Shifamed, the Calibreye System is 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.”1
The clinical study will be a non-randomized open-label feasibility study to evaluate the clinical procedure, safety, and overall performance of the Calibreye System in open-angle glaucoma patients.1
The Calibreye System is described by Shifamed as being engineered to put outflow control in the hands of glaucoma specialists, giving them the opportunity to provide personalized therapy while minimizing complications. Furthermore, 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.
Rohit Varma, MD, MPH, Founding director of Southern California Eye Institute talked about the benefits of the Calibreye System in the press release.
“Managing glaucoma remains increasingly challenging as the condition progresses to moderate and severe stages,” said Varma. “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.”
Robert Chang, president and CEO of Myra Vision talked about the importance of the first-in-human study for the company saying; “This first-in-human experience marks an important milestone as Myra transitions to a clinical stage company. […] 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.”