Specialty pharmaceutical company Eton Pharmaceuticals has announced positive top-line results for its phase III 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 non-inferiority of EM-100 topical ophthalmic solution to the comparator product in the treatment of ocular itching. Furthermore, the product demonstrated statistically significant superiority to placebo at all time points measured with no adverse events.
While the results of the study have not yet been publicly released, more information can be found from clinicaltrials.gov.
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," said Sean Brynjelsen, chief executive officer of Eton Pharma. According to IQVIA, the U.S. market for anti-allergy ophthalmic products is currently more than $600 million.
See the full press release from Eton Pharmaceuticals.
Source: Eton Pharmaceuticals