Pantheon Vision Announces Two Pre-Submission Meetings With the FDA

Pantheon Vision said it has completed two successful pre-submission meetings with the 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.

Pantheon Vision is creating bioengineered corneal implants to reduce reliance on donated corneal tissue, which is often unavailable in low- and middle-income countries.

“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,” John Sheets, President and CEO, Pantheon Vision, said in a company news release. “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.”