Article

Alcon files NDA for wet AMD drug

Fort Worth, TX—The FDA has accepted the new drug application (NDA) for Alcon Inc.'s anecortave acetate for depot suspension (RETAANE) for controlling angiogenesis in wet age-related macular degeneration.

Fort Worth, TX-The FDA has accepted the new drug application (NDA) for Alcon Inc.'s anecortave acetate for depot suspension (RETAANE) for controlling angiogenesis in wet age-related macular degeneration.

The product, which has been given fast-track status by the FDA, could be approved by late May, according to an Alcon spokeswoman.

Alcon also has submitted to the FDA results of a clinical pharmacokinetic study evaluating the effectiveness of a counter- pressure device used to eliminate or minimize reflux during the administration of the drug. The results showed that the counter-pressure device controlled reflux in 100% of study participants.

The study also found that, by controlling reflux, a higher level of the drug was absorbed than when the counter-pressure device was not used. Results of the study were also presented during the 28th annual Macula Society Meeting in Key Biscayne, FL.

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) 50 years of ophthalmology: What changed the game (Part 2)
(Image credit: Ophthalmology Times) 50 years of ophthalmology: What changed the game? (Part 1)
(Image credit: Ophthalmology Times) From MIGS to gene therapy: Inder Paul Singh, MD, celebrates the past and future of glaucoma care
(Image credit: Ophthalmology Times) NeuroOp Guru: Using OCT to forecast outcomes in ethambutol optic neuropathy
(Image credit: Ophthalmology Times) Inside NYEE’s new refractive solutions center with Kira Manusis, MD
(Image credit: Ophthalmology Times) Dilsher Dhoot, MD, on the evolution of geographic atrophy therapy: where are we now?
(Image credit: Ophthalmology Times Europe) Anat Loewenstein, MD, shares insights on the real-world results of remote retinal imaging
(Image credit: Ophthalmology Times) Two-wavelength autofluorescence for macular xanthophyll carotenoids with Christine Curcio, PhD
(Image credit: Ophthalmology Times) FLIO and the brain: Making the invisible visible with Robert Sergott, MD
© 2025 MJH Life Sciences

All rights reserved.