The prospective, non-randomised open-label feasibility study is intended to assess the clinical procedure, safety, and overall effectiveness of the Calibreye System in open angle glaucoma patients
US-based Myra Vision has started the first-in-human clinical study of its aqueous shunt therapy Calibreye System, aimed at reducing intraocular pressure (IOP) in moderate to severe glaucoma patients.
Calibreye System is a next generation glaucoma drainage device with titratable outflow control for optimal reduction of IOP.
The prospective, non-randomised open-label feasibility study is intended to assess the clinical procedure, safety, and overall effectiveness of the Calibreye System in patients with open angle glaucoma.
Myra Vision president and CEO Robert Chang said: “This first-in-human experience marks an important milestone as Myra transitions to a clinical stage company.
“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 personalised glaucoma care to the surgical armamentarium for patients with moderate to severe glaucoma.”
Myra Vision, which is a Shifamed portfolio company, has designed the titratable glaucoma therapy system to give access to outflow control to glaucoma experts. This allows the specialists to offer customised therapy while reducing complications, the medical device company said.
The Calibreye shunt, once implanted, is made to enable non-invasive in-office increases or decreases in outflow according to the changing patient’s specific treatment requirements.
Southern California Eye Institute in Los Angeles, California founding director Rohit Varma said: “Unlike other glaucoma drainage devices, the titratable outflow of the Calibreye System has the potential to achieve personalised 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.”
In June this year, the Shifamed portfolio company closed a $25m Series B financing round to further develop Calibreye System apart from advancing manufacturing capabilities, and supporting its first-in-human study.
The financing round saw participation from the Capital Partnership (TCP), the PA MedTech VC Fund, and Shifamed angel investors.