Akorn seeks approval for ocular anesthetic
Buffalo Grove, IL-Akorn Inc.'s ocular anesthetic (AK-1015 [now named Akten]) has met its endpoints in a phase III trial. The four-arm, randomized, placebo-controlled trial tested three different doses.
Buffalo Grove, IL-Akorn Inc.'s ocular anesthetic (AK-1015 [now named Akten]) has met its endpoints in a phase III trial. The four-arm, randomized, placebo-controlled trial tested three different doses. All doses met the primary efficacy endpoint (ocular anesthesia) and the secondary endpoint (duration of anesthesia) with statistical significance, according to the company.
The unit-dose, preservative-free drug is intended for use in office-based and surgical ophthalmic procedures. It is manufactured at the company's facility in Somerset, NJ.
Once approved, the product will be marketed directly to ophthalmologists. The company filed a patent in October and intends to file a new drug application with the FDA in 2Q 2007.
