Eton Pharmaceuticals on Friday said that partner Bausch Health Companies has received a complete response letter from the FDA for its filing seeking approval of the investigational therapy EM-100 to treat ocular itching associated with allergic conjunctivitis.
“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,” Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals, said in a company news release.
No concerns were raised about the clinical data in the application, so it is not anticipated that any additional clinical work will be required, according to Eton. “A response to this letter is expected shortly, and the company remains confident in the approvability of the product,” Eton stated in the news release.
Topline results from a phase 3 study unveiled last year demonstrated that EM-100 was non-inferior to a comparator product in the treatment of ocular itching, and that the topical ophthalmic solution was also significantly superior to placebo at all time points measured with no adverse events.
In February, Bausch Health Companies’ subsidiary Bausch + Lomb acquired the US rights to Eton Pharmaceuticals’ EM-100. If approved, the eye drop will be the first over-the-counter preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis. Terms of that deal were not disclosed.