The new drug application was filed after a 209 randomized patient, placebo-controlled clinical trial was conducted, which subsequently met the primary endpoints in all three dosing arms. Akorn expects to launch Akten in the first half of 2008.
According to the company, Akten is a novel, unit dose preservative-free gel formulation intended to be used in any ocular procedure that requires a topical anesthetic agent. These procedures include cataract surgery, refractive surgery, Lasik surgery, and intravitreal injections.
Akorn has filed two US patents and one international patent on the formulation and method of use of Akten.