Pantheon Vision has completed two pre-submission meetings with the US Food and Drug Administration (FDA) as the company looks to advance its corneal implants to treat corneal blindness.
The US startup said that the meetings were “successful and productive”, adding that the interactions with the agency were requested to obtain guidance on preclinical and clinical work supporting a Premarket Approval (PMA) submission.
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Corneal blindness is comprised of a group of eye disorders that change the corneal transparency, causing corneal scarring and blindness. Pathogens – including, bacteria, viruses, fungi, and protozoa – are the leading cause of the damage. Corneal blindness is the fourth-leading cause of blindness, according to the World Health Organisation (WHO).
Pantheon is developing bioengineered corneal implants to address corneal blindness. The company raised $2.5m in November 2023 to advance its technology.
Pantheon says there are more than 12.7 million people suffering from the condition. Currently, transplantation with donor tissue is the only curative treatment. However, these are not always successful and access to the required surgery is limited.
The global market for persistent corneal epithelial defect management is expected to grow to $44.5bn by 2033, up from the current valuation of $8.5bn, as per GlobalData analysis. The global corneal implant market is estimated to grow to nearly $600m by 2033.
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By GlobalDataAlso emerging in the space is the possibility of 3D-printed artificial corneas.
At the helm of Pantheon is CEO Dr John Sheets, the former head of the FDA’s Office of Device Evaluation.
Sheets said: “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.”
