The primary efficacy end point for achieving ocular anesthesia and the secondary end point for duration of anesthesia were both statistically significant for all three study drug dosages.
Akorn now intends to file a new drug application in the second quarter of 2007. Akten is intended to be used in various surgical and office-based ophthalmic procedures with an estimated market size of six million annual procedures.
“Akten is expected to be the first ethical drug product internally developed by Akorn. Akten is a unit dose, preservative free drug product and is manufactured at our Somerset, NJ facility. Once approved, Akten will be marketed directly by Akorn to ophthalmologists,” said Abu Alam, Akorn's senior vice president of New Business Development.