Pantheon Vision Announces Third Successful Meeting with the FDA Review Team

Poised for success with continued guidance from FDA as Pantheon Vision advances its bioengineered corneal implant towards a PMA Submission

Pantheon Vision, a pre-clinical stage medical device company developing bioengineered corneal implants to treat corneal blindness, announced the completion of a third productive and successful meeting with the U.S. Food and Drug Administration (FDA) review team. Last year, Pantheon Vision conducted two Pre-Submission meetings with the FDA review team for guidance on the initial stages of pre-clinical and clinical work supporting a Premarket Approval (PMA) submission.

“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,” said John Sheets, Ph.D., President and CEO of Pantheon Vision. “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.”

Corneal blindness affects more than 13 million people worldwide and more are waiting for corneal transplants. Human donated tissue has less than 50% success rate at five years. Other challenges include insufficient quantity of tissue, short shelf life of available donor tissues, lack of trained surgeons, and high transplant complication rates.

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. For more information, please visit pantheonvision.com or visit us on LinkedIn.

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