Pantheon Vision holds two pre-submission meetings with FDA

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Pantheon Vision announced the completion of two pre-submission meetings with the FDA.

According to the company, it 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 is a pre-clinical stage medical device company developing bioengineered corneal implants to eliminate corneal blindness.¹

John Sheets, president and CEO of Pantheon Vision, pointed out in a news release the company was pleased with the results of the discussions, a step towards a PMA acceptance.

“This interactive meeting was an opportunity for us to gather feedback before our planned premarket submission,” Sheets said in the 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.”

According to the company’s news release, 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.¹

Other hurdles, the company noted, include insufficient quantity of tissue, short shelf life of available donor tissues, insufficient trained surgeons, and high transplant complication rates.¹

Reference:

1. Pantheon Vision Announces Two Successful Pre-Submission Meetings With the FDA. www.businesswire.com. Published April 17, 2024. Accessed April 17, 2024. https://www.businesswire.com/news/home/20240417318271/en/Pantheon-Vision-Announces-Two-Successful-Pre-Submission-Meetings-With-the-FDA