Eton Pharma handed CRL for reformulated conjunctivitis eye drop
Eton Pharma’s grand plan to launch an over-the-counter for an ocular itch that often afflicts children has hit a dead end at the FDA, which has issued a complete response letter for EM-100.
The CRL is also bad news for Bausch & Lomb — the eye care specialist subsidiary of the company formerly known as Valeant — which had bagged the US rights to the conjunctivitis drug back in February.
“If approved, EM-100 will be the first preservative-free allergy eye drop available in the United States and will allow us to better serve the millions of Americans that experience itchy eyes due to allergies,” Joseph Papa, CEO of Bausch Health, said back then.
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