Article

Ocular topical anesthetic drug moves through the pipeline

An ocular topical anesthetic drug (Akten, Akorn Inc.) has received an FDA approvable letter. The letter identified minor CMC deficiencies that must be rectified before approval is granted.

Buffalo Grove, IL-An ocular topical anesthetic drug (Akten, Akorn Inc.) has received an FDA approvable letter. The letter identified several minor CMC deficiencies that must be rectified before final approval is granted, according to the company.

Most of these items have been addressed in the company's previous submissions to the FDA, and the remaining responses will be submitted to the FDA later this month. No additional clinical data are needed, the company added.

Before the approval process is complete, product labeling must be finalized. Proposed labeling has been received by the FDA and final printed labeling will be submitted this month.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) ASCRS 2025: Mark Lobanoff, MD, on making the move to office-based surgery
Barsha Lal, PhD, discusses the way low dose atropine affects accommodative amplitude and dynamics at the 2025 ARVO meeting
(Image credit: Ophthalmology Times) NeuroOp Guru: When eye findings should prompt neuroimaging in suspected neuro-Behcet disease
At the Association for Research in Vision and Ophthalmology (ARVO) meeting, Katherine Talcott, MD, a retina specialist at Cleveland Clinic, shared her findings on EYP-1901 (EyePoint Pharmaceuticals) in the phase 2 DAVIO study.
Dr. Jogin Desai, founder of Eyestem Research, discusses his research at the Association for Research in Vision and Ophthalmology.
(Image credit: Ophthalmology Times) ASCRS 2025: Michael Rivers, MD, shares his takeaways as a panelist at the inaugural SightLine event
(Image credit: Ophthalmology Times) ASCRS 2025: Karl Stonecipher, MD, on LASIK outcomes using an aspheric excimer laser for high myopia
John Tan talks about an emergency triage framework for retinal artery occlusion at the 2025 Association for Research in Vision and Ophthalmology (ARVO) meeting.
Dr Robert Maloney at the 2025 Controversies in Modern Eye Care meeting
Wendy Lee, MD, MS, at Controversies in Modern Eye Care 2025.
© 2025 MJH Life Sciences

All rights reserved.