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RegenerEyes is an ophthalmic solution marketed for the temporary relief of burning and irritation due to dryness of the eye. It is available in "LITE" and "PRO" formulations. While initially promoted with claims of containing placental proteins, growth factors, and cytokines for regenerative potential, anti-inflammatory effects, and tissue regeneration, the FDA has issued warning letters stating that such products would be considered unapproved drugs if marketed with these claims without a Biologics License Application. The manufacturer, Regenerative Processing Plant, LLC, has since registered the product as an over-the-counter (OTC) drug with glycerin as the active ingredient. The product is also described as a hypotonic solution that may help address tear hyperosmolarity. The FDA has also cited the manufacturer for objectionable manufacturing conditions and practices.
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