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RegenerEyes Ophthalmic Solution

Development stage
Phase 1
Lead developer
Regenerative Processing Plant
Modality
Injectable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Small Molecules
Administration
Ophthalmic
01

Overview

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.

Brand names
Regener-EyesRegener-Eyes LITERegener-Eyes PRO
Other names
Amniotic membrane extract eye dropsHuman amniotic fluid extract eye drops

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