Pantheon Vision Advances Corneal Implant Development

Pantheon Vision announced the completion of its third meeting with the FDA review team as the company continues its development of bioengineered corneal implants, designed to address the global challenge of corneal blindness.

Over the past year, Pantheon Vision has engaged in two pre-submission meetings with the FDA, seeking guidance on the early stages of preclinical and clinical work to support a future premarket approval (PMA) submission. According to Pantheon, these discussions have been pivotal in shaping the development strategy for the company’s implant technology.

“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,” John Sheets, PhD, President and CEO of Pantheon Vision, said in a company news release. “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. 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 globally. Human-donated corneal tissue currently faces several challenges, including a less than 50% success rate at 5 years, limited availability, short shelf life, and a lack of trained surgeons, according to Pantheon. Additionally, high complication rates associated with corneal transplants further underscore the urgency for innovative alternatives.

Pantheon Vision’s bioengineered corneal implants aim to address these challenges by offering a durable, scalable, and more effective solution.