The FDA did not approve Eton Pharmaceuticals’ eye drop for allergic conjunctivitis, serving up a complete response letter that raised “no concerns” about the clinical data in the drug’s application. The company doesn’t expect the agency to ask for more data and remains optimistic.
“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,” said Eton Pharma CEO Sean Brynjelsen in a statement Friday. The company’s stock dipped nearly 20% in after-hours trading.
The FDA issued the letter to “Eton’s partner,” which went unnamed in the company’s statement announcing the holdup. The Chicago-area biotech licensed EM-100, an eye drop to ease itchy eyes from allergic conjunctivitis, to Canada’s Bausch Health in February. Eton had already submitted the drug for FDA approval when Bausch picked up the U.S. rights.
"In 2019, Bausch Health is pivoting to offense by strategically enhancing our pipeline and portfolio. EM-100 is a new, differentiated eye drop that will complement Bausch + Lomb's broad range of integrated eye health products," said Bausch Health CEO Joseph Papa at the time. "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."
Eton started 2019 with plans to become a commercial-stage biotech. And though EM-100 is off the table for now, the company has a handful of prospects under FDA review. These include ET-202, an injectable drug for low blood pressure that should receive an FDA decision in October, and a pair of injectable nutrition products for hospital settings.
“We remain on track to reach our goal of becoming a commercial revenue company in 2019 as we expect multiple product launches in the second half of this year. We have begun preparing for the launch of ET-202, our ready-to-use injectable formulation of phenylephrine which, if approved, could be the first and only FDA-approved ready-to-use phenylephrine product in the market,” Brynjelsen said in the company's first-quarter earnings statement.