Article

Shire to submit NDA for dry eye treatment

Following a meeting with the FDA last week, Shire has announced that it intends to submit a New Drug Application (NDA) for its dry eye disease treatment, lifitegrast, in the first quarter of 2015, as it completes remaining chemistry and manufacturing work.

 

Lexington, MA-Following a meeting with the FDA last week, Shire has announced that it intends to submit a New Drug Application (NDA) for its dry eye disease treatment, lifitegrast, in the first quarter of 2015, as it completes remaining chemistry and manufacturing work.

“As we prepare for the FDA submission, we will also form an ophthalmic business unit that will focus on the commercialization of our ophthalmic pipeline products,” aid Flemming Ornskov, MD, chief executive officer of Shire.

 

 

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) 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
1 expert is featured in this series.
1 expert is featured in this series.
© 2025 MJH Life Sciences

All rights reserved.