Eton Pharmaceuticals announced that the U.S FDA provided Eton’s partner with a Complete Response Letter relating to the application for investigational eye drops.
In February, a subsidiary of Bausch Health acquired the U.S. rights to Eton's EM-100, hopeful that it would be the first over-the-counter preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis. Eton 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.
However, the FDA's CRL means the agency will not approve the application or abbreviated application in its present form. Eton remains hopeful, noting that no concerns were raised about the clinical data in the application.
“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,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals.
Read the press release
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