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.
Spun out of Imprimis Pharma (which specializes in compounding) in 2017, Eton’s pledge is to develop formulations of approved drugs that are competitive in one way or another — safer, most effective, cheaper, or offered for a different indication. The resulting regulatory filings go through a pathway between an NDA and an ANDA.
It’s unclear which reference drug EM-100 is based on.
Despite the setback, Eton plans to respond to regulators quickly as they are not requiring any additional clinical work.
“We believe the issues cited in the CRL can be addressed in the coming months, and we remain confident that EM-100 will be available to patients as quickly as possible,” CEO Sean Brynjelsen said in a statement.
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