Bausch Health Companies and Bausch + Lomb, its wholly owned subsidiary and a leading global eye health company, and Eton Pharmaceuticals announced a subsidiary of Bausch Health has acquired the U.S. rights to Eton Pharmaceuticals' EM-100, an investigational eye drop that, if approved, will be the first over-the-counter (OTC) preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis. EM-100 has been submitted to the U.S. Food and Drug Administration (FDA) for review.

"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 Joseph C. Papa, chairman and CEO, Bausch Health. "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 Americans1 that experience itchy eyes due to allergies."

Eton Pharmaceuticals previously reported positive top-line results from a Phase 3 trial in which EM-100 demonstrated statistically significant superiority to placebo and no adverse events, and demonstrated non-inferiority to a comparator product in the treatment of ocular itching.

"We believe that partnering with Bausch + Lomb, a global leader in consumer ophthalmology, will allow us to maximize EM-100's commercial potential and provide broad accessibility for patients," said Sean Brynjelsen, chief executive officer, Eton Pharmaceuticals.

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