Myra Vision's Innovative Glaucoma Study Receives FDA Greenlight
Myra Vision's FDA Approval for Groundbreaking Study in Glaucoma
The FDA has given Myra Vision the green light to embark on a significant study called the ADAPT trial, which focuses on the safety and efficacy of the Calibreye™ Titratable Glaucoma Therapy™ (TGT) Surgical System. This innovative project aims to address the critical needs of patients suffering from refractory glaucoma.
Understanding the ADAPT Study
The ADAPT study is designed as a prospective, nonrandomized, open-label trial. It is set to evaluate the Calibreye™ TGT Surgical System in approximately 70 glaucoma patients over a period of 12 months. This patient-centric approach highlights the hope that personalized therapy can significantly improve outcomes for individuals affected by this challenging eye condition.
Expert Insights on the Need for Innovation
According to Dr. David S. Friedman, a leading expert in glaucoma treatment, lowering intraocular pressure (IOP) is vital for protecting optic nerve health and preserving vision. Despite various existing therapies, many do not effectively manage IOP, which leaves room for safer, more effective alternatives. He expressed enthusiasm about the ADAPT study's potential to confirm the promising results observed in early clinical experiences with the Calibreye System.
The Calibreye System: A Unique Solution
The unique Calibreye System places control of aqueous outflow directly in the hands of ophthalmologists, facilitating a tailored approach to treatment. With the ability to adjust and reverse outflow settings, the system empowers doctors to meet the changing needs of individual patients, potentially transforming glaucoma management.
Company Vision and Patient Commitment
Robert Chang, the President and CEO of Myra Vision, emphasized that this FDA approval is a landmark achievement for the company as it moves forward with its mission of innovating glaucoma care. The technology could provide an essential solution for many patients who currently lack effective treatment options.
Glaucoma: A Global Challenge
Glaucoma is one of the leading causes of irreversible blindness globally, affecting around 80 million people. To control disease progression and minimize loss of vision, patients often seek effective interventions for managing IOP. Traditional surgeries and newer devices frequently fall short in providing adaptable solutions tailored to specific patient needs, highlighting the importance of Myra Vision's efforts.
Investigational Use and Market Potential
Please note that the Calibreye System is intended for investigational use only and is not yet available for sale either in the U.S. or internationally, as it undergoes further trials and validations.
About Myra Vision
Myra Vision is a privately held company within the Shifamed LLC portfolio, dedicated to developing innovative aqueous shunt technologies aimed at providing custom solutions for IOP management. This ambition underscores their goal of reducing procedural complexities and complications associated with glaucoma treatment.
About Shifamed, LLC
Shifamed LLC is renowned for its focus on medical innovation, established by entrepreneur Amr Salahieh. The firm strives to streamline the development process in the medical field, fostering breakthroughs that enhance patient health and longevity.
Frequently Asked Questions
What is the purpose of the ADAPT study?
The ADAPT study aims to evaluate the safety and effectiveness of the Calibreye™ system for glaucoma patients.
Who is leading the ADAPT clinical trial?
The trial is led by Myra Vision with oversight from experts in glaucoma treatment, including Dr. David S. Friedman.
What is unique about the Calibreye system?
The Calibreye system offers adjustable and reversible outflow control for personalized glaucoma treatment.
How many patients will be involved in the study?
Approximately 70 patients suffering from refractory glaucoma will participate in the ADAPT study.
Is the Calibreye system currently available for use?
No, the Calibreye system is currently for investigational use only and is not available for sale.
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