Pantheon Vision, a medical device company focused on bioengineered corneal implants, has announced the successful completion of a third meeting with the U.S. Food and Drug Administration (FDA) review team. The discussion centered on the design and bioengineered materials of their corneal implant, a crucial step toward a Premarket Approval (PMA) submission. This progress marks a significant milestone in the development of a novel treatment for corneal blindness, a condition affecting millions worldwide.
Addressing Corneal Blindness with Bioengineered Implants
Corneal blindness affects more than 13 million individuals globally, with a significant number awaiting corneal transplants. Current treatment options using human donor tissue face challenges, including a success rate of less than 50% at five years, insufficient tissue availability, short tissue shelf life, a shortage of trained surgeons, and high transplant complication rates. Pantheon Vision aims to overcome these limitations with its bioengineered corneal implants.
FDA Guidance and Future Milestones
"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," said John Sheets, Ph.D., President and CEO of Pantheon Vision. "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." The company anticipates another meeting with the FDA in the spring, marking another milestone in the development of their advanced bioengineered solution.
About Pantheon Vision
Pantheon Vision is a pre-clinical stage medical device company developing bioengineered corneal implants to improve corneal procedures and reduce the reliance on donor tissue to address corneal blindness in emerging and developed markets.
