New anaesthetic approved

Article

Akten Ophthalmic Gel 3.5%, a topical anaesthetic for the eye, has become the first new ocular anaesthetic to receive FDA approval in 40 years, according to a statement released by Akorn, Inc, the maker of Akten.

Akten Ophthalmic Gel 3.5%, a topical anaesthetic for the eye, has become the first new ocular anaesthetic to receive FDA approval in 40 years, according to a statement released by Akorn, Inc., the maker of Akten.

Akten, a preservative-free lidocaine gel, is suitable for all ocular procedures requiring administration of a topical anaesthetic, either in hospital or in an office. The gel is designed to be stored at room temperature.

The approval follows Akorn's New Drug Application filing in June 2007, which was submitted after the Phase III clinical trial achieved its primary endpoint. Akorn plans to make Akten available before the end of the month.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Recent Videos
Jeremiah Tao, MD, FACS, discusses his Egyptian Ophthalmological Society keynote, which focused on risk management and avoiding surgical complications in oculofacial surgery
Omer Trivizki, MD, MBA, a retina specialist from Tel Aviv Medical Center, speaks about VOY-101, a Novel, Complement-Modulating Gene Therapy for Geographic Atrophy at the American Society of Retina Specialists (ASRS) Annual Meeting
João Pedro Marques, MD, MSc, PhD discusses a retrospective study of 800 patients with inherited retinal diseases during the American Society of Retina Specialists (ASRS) annual meeting
© 2025 MJH Life Sciences

All rights reserved.