FDA rejects Bausch Health, Eton's EM-100 for allergic conjunctivitis

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. CEO Sean Brynjelsen commented "we believe the issues cited in the [complete response letter] can be addressed in the coming months, and we remain confident that EM-100 will be available to patients as quickly as possible." Shares in Eton dropped nearly 20% on the news. 

Eton noted that the FDA did not cite any concerns regarding the clinical data included in the filing, and that additional clinical work is "not anticipated." The company added that a response to the FDA is expected shortly.

Top-line results from a Phase III 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.

Bausch Health inked a deal with Eton in February gaining US rights to EM-100. Eton recently disclosed that Bausch Health will hold responsibility for all remaining regulatory and commercial activities related to the therapy, with Eton eligible for a milestone payment upon product launch, as well as a royalty on sales. 

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