Positive feedback from interactive meetings provides guidance for road to PMA submission

Pantheon Vision, a pre-clinical stage medical device company developing bioengineered corneal implants to eliminate corneal blindness, announced today the completion of two successful and productive Pre-Submission meetings with the U.S. Food and Drug Administration (FDA). Pantheon Vision requested these early interactions with the FDA review team to obtain agency guidance on preclinical and clinical work supporting a Premarket Approval (PMA) submission.

Corneal blindness is a leading cause of vision loss in the world. Currently, more than 13 million people 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, insufficient trained surgeons, and high transplant complication rates.

“We are thrilled with the results of the Pre-Submission meetings with the FDA as this is a pivotal step towards a PMA acceptance. This interactive meeting was an opportunity for us to gather feedback before our planned premarket submission,” said John Sheets, President and CEO, Pantheon Vision. “I appreciate the importance of these meetings and the guidance provided. We are excited at the prospect of bringing a new solution to corneal blindness as an alternative to the current treatment options.”

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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