Pantheon Vision Advances Development of Bioengineered Corneal Implants
Pantheon Vision has announced the successful completion of its third meeting with the FDA review team, marking significant progress in the development of its bioengineered corneal implants. These implants are designed to tackle the global challenge of corneal blindness, a condition that affects over 13 million people worldwide.
Collaborative Progress with the FDA
Over the past year, Pantheon Vision has engaged in two pre-submission meetings with the FDA to receive guidance on preclinical and clinical development. These discussions are critical to shaping the pathway toward a future Premarket Approval (PMA) submission.
Insights from Leadership
John Sheets, PhD, President and CEO of Pantheon Vision, emphasized the importance of these interactions:
“We are grateful for the time and guidance the FDA has awarded us during these crucial appointments to ensure we stay on track with our corneal implant candidate. This most recent meeting focused on the design and bioengineered materials of our corneal implant, which was very positive and an essential step before we move to the next phase. We anticipate another check-in with the FDA in the spring, when we reach another milestone in the development of our advanced bioengineered solution for treating corneal blindness.”
The Global Challenge of Corneal Blindness
Corneal blindness is a pressing issue globally, with limited solutions currently available. Challenges with traditional human-donated corneal tissue include:
• Low Success Rates: Less than 50% success rate at 5 years.
• Limited Availability: A shortage of donor tissue.
• Short Shelf Life: Restricting widespread accessibility.
• Lack of Trained Surgeons: Limiting surgical options in many regions.
• High Complication Rates: Associated with corneal transplants.
Pantheon Vision’s Bioengineered Solution
Pantheon Vision’s bioengineered corneal implants aim to overcome these challenges by providing:
• Durability: Long-lasting performance.
• Scalability: A solution that can be produced and distributed widely.
• Improved Outcomes: Reduced complications and higher success rates compared to traditional corneal transplants.
Looking Ahead
Pantheon Vision’s next FDA meeting is anticipated in the spring, marking another milestone in the journey to bring this innovative solution to patients. With its cutting-edge technology and commitment to addressing the limitations of traditional treatments, the company is poised to make a significant impact on the treatment of corneal blindness worldwide.
Reference:
