Pantheon Vision completes third pre-submission meeting with the FDA

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Pantheon Vision has completed a third meeting with the US Food and Drug Administration (FDA) review team.

Last year, the company conducted 2 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 for the company’s bioengineered corneal implants to eliminate corneal blindness.

John Sheets, PhD, president and CEO of Pantheon Vision commented on the meeting with the FDA in a press release from the company.¹

“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 Sheets. “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 according to the company, with even more waiting for corneal implants.¹

Human donated tissue has less than a 50% success rate at 5 years, among other issues such as short shelf life and insufficient tissue available.¹ The company aims to tackle these issues with its bioengineered corneal implants.

References:

1. Pantheon Vision Announces Third Successful Meeting with the FDA Review Team. Press Release. Published January 22, 2025. Accessed January 22, 2025. https://www.businesswire.com/news/home/20250122102716/en/Pantheon-Vision-Announces-Third-Successful-Meeting-with-the-FDA-Review-Team