FDA approves new drug application for ophthalmic gel 3.5%

Lake Forest, IL-Akorn Inc. has announced approval of an FDA new drug application (NDA) for ophthalmic gel 3.5% (Akten), a topical, ocular anesthetic formulation. The gel is the first NDA ocular anesthetic approved by the FDA in 40 years, and it will be commercially available this October, according to a prepared statement issued by Akorn.

The novel, unit dose is a preservative-free lidocaine gel that is intended to be used in any ocular procedure that requires a topical anesthetic agent.

"This is a very important milestone in our company's history, because it represents our first internally developed NDA drug product," said Arthur S. Przybyl, Akorn's president and chief executive officer. "We expect [the ophthalmic gel] to become the standard of care whenever an ocular anesthetic is prescribed. [It] will be manufactured at our Somerset, NJ, facility, and [it] will be marketed directly to hospitals and ophthalmologists, with a targeted detail sales effort by our 65 sales representatives."

The estimated market size for the ophthalmic gel is approximately 11 million procedures annually, according to the company. The major procedures include cataract and refractive surgeries, LASIK, and intravitreal injection. The company said that is has filed two United States patents and one international patent on the formulation and method use of the ophthalmic gel.