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Myra Vision Begins US Trial of Adjustable Calibreye Glaucoma System

by Dr. Priya Deshmukh - Senior Editor, Health
by Dr. Priya Deshmukh - Senior Editor, Health

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Myra vision Begins Patient Enrollment in groundbreaking Glaucoma Study

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BOSTON, MA – Myra Vision, a leading medical technology firm, has announced the commencement of it’s pivotal ADAPT clinical study, marking a meaningful milestone in the progress of its Calibreye system. The initiation of the study signifies a step towards a novel approach to managing glaucoma, a leading cause of irreversible blindness worldwide.

The Calibreye System: A New Approach to IOP Control

The Calibreye system utilizes a subconjunctival filtration procedure, a minimally invasive technique designed to reduce intraocular pressure (IOP) in patients with moderate to advanced glaucoma. Currently, these procedures are used in a limited number of eligible patients requiring significant pressure reduction. Myra Vision believes Calibreye’s personalized IOP control will provide physicians with increased confidence in treating patients who currently have limited effective options.

Glaucoma affects over 79 million people globally, and that number is projected to reach 111.8 million by 2040, according to a 2023 report by the BrightFocus Foundation. Traditional glaucoma treatments, like eye drops and surgery, don’t always provide adequate pressure control for all patients, highlighting the need for innovative solutions like Calibreye.

Understanding Subconjunctival Filtration Procedures

Subconjunctival filtration procedures work by creating a new drainage pathway for fluid within the eye, lowering IOP. The Calibreye system aims to personalize this process, tailoring the drainage to each patient’s specific needs. This personalized approach contrasts with more generalized surgical interventions.

Here’s a comparison of traditional glaucoma treatments versus emerging filtration procedures:

Treatment Type Mechanism Personalization Invasiveness
Eye Drops Reduce fluid production or increase outflow. Limited Non-invasive
Laser Surgery (e.g., SLT) Enhances natural drainage pathways. Moderate minimally

What is the Calibreye adjustable glaucoma system and how does it work?

Myra Vision Begins US Trial of Adjustable Calibreye Glaucoma System

The landscape of glaucoma treatment is evolving,and a meaningful step forward has just been taken. Myra Vision has announced the commencement of a US clinical trial for its innovative Calibreye adjustable glaucoma implant. This marks a crucial milestone for the company and offers potential new hope for individuals battling this sight-threatening condition.

Understanding Glaucoma and Current Treatment Options

Glaucoma isn’t a single disease, but a group of conditions that damage the optic nerve, often linked to elevated intraocular pressure (IOP). Millions worldwide are affected, and early detection is vital to prevent irreversible vision loss.Current treatment strategies primarily focus on lowering IOP through:

* Eye Drops: The most common initial treatment, requiring consistent daily governance.

* Laser Therapy: procedures like selective laser trabeculoplasty (SLT) can improve fluid drainage.

* Conventional Surgery: Trabeculectomy and glaucoma drainage devices (GDDs) are more invasive options, frequently enough considered when other methods fail.

However, these approaches aren’t always sufficient, and many patients require multiple interventions. The Calibreye system aims to address these limitations with a more adaptable solution.

The Calibreye System: A Novel Approach to Glaucoma Drainage

The calibreye system represents a paradigm shift in glaucoma management. Unlike traditional GDDs with fixed outflow characteristics, Calibreye is designed to be adjustable post-implantation. This adjustability is key.

Here’s how it works:

  1. Implantation: A small implant is surgically placed in the eye to create a new drainage pathway for aqueous humor, the fluid that fills the eye.
  2. Post-Operative Adjustment: Following surgery, the ophthalmologist can non-invasively adjust the implant’s outflow resistance using an external magnetic tool.
  3. Personalized IOP Control: This allows for fine-tuning of IOP control, tailored to the individual patient’s needs and response.

This adjustability minimizes the risk of over- or under-drainage,potentially reducing complications associated with traditional glaucoma surgery.

US Trial Details and What to Expect

The US trial is a prospective, multi-center study evaluating the safety and efficacy of the Calibreye system in patients with moderate to severe glaucoma. Key aspects of the trial include:

* Patient Population: Individuals with open-angle glaucoma who have not achieved adequate IOP control with medication.

* Trial Sites: Leading ophthalmology centers across the United States.

* Primary Endpoint: The study will assess the proportion of patients achieving a target IOP reduction without the need for additional glaucoma medications.

* Follow-up Period: Patients will be monitored for an extended period to evaluate the long-term safety and effectiveness of the implant.

Initial data from European trials have been promising, demonstrating significant IOP reductions and a favorable safety profile.The US trial will provide crucial data to support potential FDA approval and wider availability of the Calibreye system.

Benefits of an Adjustable Glaucoma implant

The potential benefits of the Calibreye system are substantial:

* Personalized Treatment: tailoring IOP control to each patient’s unique needs.

* Reduced Complications: Minimizing the risks associated with over- or under-drainage.

* Potential for Medication Reduction: Decreasing reliance on daily eye drops.

* improved Quality of Life: Offering a more sustainable and effective solution for glaucoma management.

* Non-Invasive Adjustments: Adjustments can be made externally, avoiding the need for further surgery.

The Future of Glaucoma Treatment

The Calibreye trial represents a significant advancement in the field of glaucoma.The development of adjustable implants aligns with the growing trend towards personalized medicine, where treatments are customized to the individual patient.

Beyond the Calibreye system, research continues on other innovative approaches, including:

* Gene therapy: Targeting the genes responsible for glaucoma development.

* Neuroprotection: Protecting the optic nerve from further damage.

* Minimally Invasive Glaucoma Surgery (MIGS): A range of less invasive procedures aimed at improving fluid drainage.

The ongoing research and development in glaucoma treatment offer renewed hope for preserving vision and improving the lives of those affected by this debilitating condition. The results of the US Calibreye trial will be closely watched by ophthalmologists and patients alike.

Dr. Priya Deshmukh Senior Editor, Health

Dr. Priya Deshmukh Senior Editor, Health Dr. Deshmukh is a practicing physician and renowned medical journalist, honored for her investigative reporting on public health. She is dedicated to delivering accurate, evidence-based coverage on health, wellness, and medical innovations.

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