The companies, Regener-Eyes and M2 Biologics, were illegally selling unapproved eye drops, which the FDA said contained amniotic-fluid, to treat dry eyes. In fact, there is not a single amniotic ...

After receiving a warning letter from the FDA on Aug. 16 citing “significant violations” related to two Regener-Eyes ophthalmic products, the company has implemented several improvements to ...

The communication links to earlier letters to two manufacturers -- makers of Regener-Eyes and StimulEyes-- warning that the products would need an approved Biologics License Application (BLA ...

In a letter to Carl Harrell, MD, CEO of Regenerative Processing Plant in Palm Harbor, Florida, the agency said the company's Regener-Eyes Pro and Regener-Eyes Lite products were unapproved new ...

Related: Eye drops recalled after CDC links them to vision loss, 1 death The FDA's letters don't specifically mention amniotic fluid in their main text, but they do note that Regener-Eyes was ...

A Novel Social Media Collective. TAMPA, Fla., May 15, 2023 /PRNewswire/ -- Regener-Eyes® is dedicated to the "Patient First" philosophy. By harnessing the power of social media, we are bringing ...

PALM HARBOR, FL / ACCESSWIRE / March 10, 2021 / Regener-Eyes®, a leading first-in-class biologic eye drop made of naturally-occurring cytokines and growth factors, today announced the addition of ...

PALM HARBOR, Fla., Jan. 26, 2021 /PRNewswire/ -- Regener-Eyes® LLC, a subsidiary of Regenerative Processing Plant Inc., announced that Regener-Eyes®, a first in class biologic eye drop ...