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."
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
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.