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Pantheon Vision reports positive pre-clinical FDA meeting on bioengineered corneal implants

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6 min read

Pantheon Vision announced it completed a “third productive and successful” pre-submission meeting with the FDA in regard to its investigative bioengineered corneal implants.

Refresh me on this company.

Founded in 2023 and headquartered in Baltimore, Maryland, the pre-clinical medical device company is focused on one goal: eliminating corneal blindness.

How it’s doing this: By developing bioengineered corneal implants with the intent to reduce the global reliance on donated corneal tissues—with a particular emphasis on low-and-middle-income countries (LMICs).

Why reduce the dependence on donated corneas?

Corneal transplant surgery is considered the most frequently performed type of transplant worldwide.

However: Despite an over 97% success rate of corneal transplants restoring vision, the demand for such donations has become so high (an estimated 12.7 million) that only around one in 70 individuals are actually able to receive a transplant.

While efforts and progress are being made to increase the availability and number of corneal transplants performed in LMICSthanks to nonprofits and eye banks—there remains a “severe imbalance” in both supply (trained surgeons) and demand.

  • In fact, a 2016 global survey identified that approximately 53% of the world’s population had no access to corneal transplantation.

Any notable risks associated with these transplants?

A few … including ocular complications, rejection, and (in rare cases) disease transmission—as well as the major barrier of limited access to ethically donated and allocated human corneal tissue (HCT).

Note: Other barriers leading to a lack of access to these transplants include economic, cultural, technological, political, and ethical.

Let’s circle back to these bioengineered corneal implants. Why use them?

A major reason: To eliminate the need to rely on donor cornea availability and tissue banks—which, as we’ve mentioned, are lacking in numbers.

Over the last few years, research has explored the use of bioengineered cell-free implantable medical devices as potential substitutes for human corneal stromal tissue.

The results so far: Investigators have found these bioengineered alternatives to be “a safe and feasible means to reverse the pathologic corneal thinning and deformation in advanced keratoconus.”

  • Even further: Visual gains observed following transplantation were determined to be “equivalent outcomes” to that of standard transplant surgery with human donors.
  • And in terms of storage: The artificial corneas could be stored for up to 2 years before implantation—enabling time to transport the corneas into LMICs’ higher-demand areas.

Plus, see here, here, and here for other recent promising (and some ongoing) clinical investigations.

Definitely sounds exciting! Now what do we know about Pantheon’s implants?

Admittedly, the company has not released much information about its bioengineered corneal implants.

However, over the last 2 years, the Pantheon has secured over $4 million in funding to support the continued advancement of the implants.

  • The source of those funds: KeraLink International, a 501(c)3 nonprofit organization owned by CorneaGen (the largest global provider of corneal tissue for transplantation).

How about the company’s meetings with the FDA?

All three of these pre-submission meetings were conducted with the FDA’s review team.

Their purpose: To go over guidance on the initial stage of pre-clinical and clinical work needed to support a future premarket approval (PMA) submission of the bioengineered corneal implants, according to Pantheon.

“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,” stated John Sheets, PhD, Pantheon’s president and CEO.

Exactly how many pre-submission meetings are needed before a PMA?

There’s actually no set amount required.

Here’s a rundown on the general step-by-step process:

  • A company first submits to the FDA a pre-submission application
  • The FDA then reviews the app and provides feedback (within 70 days)
  • A meeting date is set, and the FDA offers preliminary responses ahead of the agreed-upon date
  • The company and the FDA meet (for around 1 hour), with the company submitting meeting notes to the FDA afterward (within 15 days)
  • The FDA reviews meeting notes and makes any corrections (within 60 to 75 days)
  • The company then receives feedback from the FDA

This cycle can repeat as many times as needed—however, it’s been noted that the FDA generally only meets to discuss a product or indication one time.

Interesting. So what does this mean for Pantheon?

As these pre-submission meetings are typically reserved for when a device is nearing its final design, it’s probably safe to conclude that the company is planning for an eventual market application submission in the near future.

In fact, Dr. Sheets noted that Pantheon expects “another check in with the FDA in the spring, when we reach another milestone” in developing its “advanced bioengineered solution.”

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