Eton Pharmaceuticals announced positive topline results for its phase 3 study of EM-100 ophthalmic solution. If approved, EM-100 would be the first topical, preservative-free formulation for the treatment of ocular itching associated with allergic conjunctivitis. Results from the trial demonstrated noninferiority of EM-100 topical ophthalmic solution to the comparator product in the treatment of ocular itching, according to a company news release. Furthermore, the product demonstrated statistically significant superiority to placebo at all time points measured with no adverse events.
Eton believes the availability of a preservative-free product for this indication would offer patients a valuable new treatment option. “We look forward to a timely FDA review and bringing the product to patients in 2019,” Sean Brynjelsen, chief executive officer of Eton Pharma, said in the news release.