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An Ophthalmic Solution 

THIS PRODUCT IS NO LONGER AVAILABLE

 

IMPORTANT NOTICE:  When StimulEyes was introduced to the market in the summer of 2020, it was compliant with the PHS Act Section 361 and 21 CFR Part 1271 requirements for HCT/Ps.  In May 2021, the FDA decided to regulate products with compositions comparable to StimulEyes under Section 351 of the PHS Act, as a drug or biological, not an HCT/P.  M2 met with the FDA and corresponded through written communication, making our views known as to the nature and proper categorization of our product.   Recent proceedings, including the FDA’s April 10, 2023, Public Safety Notification on Amniotic Fluid Eyedrops, underscore that the FDA is not receding from its latest position. Accordingly, we have voluntarily removed StimulEyes from the marketplace.

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ABOUT STIMULEYES

Ophthalmic Solution

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