Article

New PDUFA date for Alimera’s Iluvien

Alimera Sciences’ recent resubmission of the new drug application (NDA) for its fluocinolone acetonide intravitreal implant (Iluvien) has been received by the FDA as a complete class 2 response to the agency’s October letter, and a prescription drug user fee act (PDUFA) goal date of Sept. 26 has been established.

 

Atlanta-Alimera Sciences’ recent resubmission of the new drug application (NDA) for its fluocinolone acetonide intravitreal implant (Iluvien) has been received by the FDA as a complete class 2 response to the agency’s October letter, and a prescription drug user fee act (PDUFA) goal date of Sept. 26 has been established.

In the resubmission, Alimera responded to questions raised in the FDA’s October letter, and provided data from patient and physician experiences with the applicator in the United Kingdom and Germany, where the product is currently commercially available.

“We are pleased to have achieved our goal of resubmitting our NDA in the first quarter and to have a PDUFA goal date set for a decision from the FDA,” said Dan Myers, Alimera’s president and chief executive officer. “We look forward to the FDA’s response to our NDA and hope that we will be able to make (the applicator) available to patients in the United States who are suffering from chronic diabetic macular edema.”

 

For more articles in this issue of Ophthalmology Times eReport, click here.

 

 

To receive weekly clinical news and updates in ophthalmology, subscribe to the Ophthalmology Times eReport.

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) 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
(Image credit: Ophthalmology Times) Structure-function correlates using high-res OCT images with Karl Csaky, MD, PhD
(Image credit: Ophthalmology Times) SriniVas Sadda, MD, on high-res OCT of atrophic and precursor lesions in AMD
(Image credit: Ophthalmology Times) Christine Curcio, PhD, shares histology update supporting review software and revised nomenclature for <3 μm OCT
© 2025 MJH Life Sciences

All rights reserved.