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Myra Vision's Groundbreaking Study at AGS 2025

Myra Vision, a key player in innovative medical technology and part of the Shifamed portfolio, has made waves in the medical community with recent presentations at the annual American Glaucoma Society (AGS) meeting held in Washington, D.C. Dr. Arsham Sheybani, an esteemed Associate Professor at Washington University School of Medicine, presented the promising three-month outcomes from Myra Vision’s feasibility study on its pioneering Calibreye Titratable Glaucoma Therapy™ (TGT) Surgical System.

The clinical trial, which was carefully designed as a prospective, non-randomized open-label study, primarily aimed to assess the safety and efficacy of the Calibreye system for treating patients with open-angle glaucoma. This disorder, which is a leading cause of irreversible blindness, impacts approximately 80 million individuals globally, with a substantial number facing moderate to severe forms that necessitate extensive intraocular pressure (IOP) reduction.

In total, 43 patients with moderate to late-stage glaucoma participated in the international study, which was conducted across four medical sites in three different countries. A significant highlight of the study was that 33 of these patients achieved follow-up assessment beyond three months, providing a strong data pool. The medical oversight during this trial was led by Dr. Keith Barton, a renowned Consultant Ophthalmologist and Glaucoma Specialist from Moorfields Eye Hospital and a Professor at University College London’s Institute of Ophthalmology.

Key Findings from the Study

The results showcased compelling evidence of the Calibreye system's effectiveness:

• - IOP Reduction: There was a remarkable 44.9% decrease in IOP compared to baseline measurements, with average pressure recorded at 12.1 mmHg.
• - Medication Independence: A striking 88% of participants were able to discontinue glaucoma medication, while 100% were either medication-free or were using the same or fewer medications compared to their baseline treatment.
• - Overall Medication Reduction: Patients experienced a mean reduction of over three glaucoma medications each, resulting in a 96% decline from baseline figures.
• - Safety and Feasibility: None of the patients required additional bleb needling procedures, and every device was successfully implanted with a full completion rate for the necessary titrations, averaging around 2.2 per patient.

Dr. Sheybani expressed a sense of optimism regarding these findings, believing they indicate a solid performance of the Calibreye shunt. He highlighted that this technology could revolutionize how IOP control is managed, allowing ophthalmologists to make adjustments in an office setting rather than through more complex surgical interventions.

Dr. Rohit Varma, the Founding Director of Southern California Eye Institute, also contributed valuable insights during the conference, presenting a poster summarizing outcomes related to the titration process of the Calibreye system.

Looking to the Future

Following these encouraging initial results, Robert Chang, the President and CEO of Myra Vision, voiced his eagerness for the continued exploration of the Calibreye system. He emphasized the importance of tailoring post-operative care to match individual patient needs, noting that they aim to expand patient enrollment and clinical sites further as they prepare for a pivotal study IDE submission.

Thus far, the Calibreye System remains investigational and is not commercially available within the U.S. or elsewhere. However, as researchers and medical professionals around the world faced challenges in managing IOP effectively, the introduction of the Calibreye system stands as a beacon of hope for those battling the severe impacts of glaucoma.

As Myra Vision continues on this promising path, it aims to contribute significantly to patient care and the evolving landscape of glaucoma treatment, potentially impacting millions around the globe.

For further details about Myra Vision and their innovative endeavors, visit Myra Vision.