FDA approval for non-infectious uveitis drug

Article

Allergan has been given FDA approval for its drug Ozurdex (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation.

Allergan has been given FDA approval for its drug Ozurdex (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation.

The drug was assessed in a 26 week, multi-centre, double-masked, randomized clinical study in which 77 patients received Ozurdex 0.7mg and 76 patients received sham injections.

After a single injection of Ozurdex, the percentage of patients reaching a vitreous haze score of zero (being no inflammation) was statistically significantly greater for patients in the Ozurdex treated group versus sham at the week eight primary endpoint. In addition, the percentage of patients achieving a 3-line improvement in BCVA was 43 per cent in the Ozurdex treated group, versus 7 per cent for the sham group at week eight.

Newsletter

Join ophthalmologists across Europe—sign up for exclusive updates and innovations in surgical techniques and clinical care.

Recent Videos
Christine Curcio, PhD, of the University of Alabama at Birmingham Heersink School of Medicine, shares histology update and revised nomenclature for OCT with Sheryl Stevenson of the Eye Care Network and Ophthalmology Times
SriniVas R. Sadda, MD, FARVO, shares key points from his retina presentation at the International SPECTRALIS Symposium
Robert Sergott, MD, describes fluorescence lifetime imaging ophthalmoscopy (FLIO) and the International SPECTRALIS Symposium – And Beyond (ISS) in Heidelberg, Germany.
Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine - Qatar, spoke with Ophthalmology Times Europe about his presentation. It's titled "An eye on neurodegenerative diseases: Challenging the dogma" at the International SPECTRALIS Sympsoium. In conversation with Hattie Hayes, Ophthalmology Times Europe
Anat Loewenstein, MD, describes her presentation on remote imaging for age-related macular degeneration and geographic atrophy at the International SPECTRALIS Symposium, in conversation with Hattie Hayes of Ophthalmology Times Europe
Tyson Brunstetter, OD, PhD, a US Navy Aerospace Optometrist at the NASA Johnson Space Center in Houston, Texas, shares key takeaways from his keynote at the International SPECTRALIS Symposium (ISS)
Rayaz Malik, MBChB, PhD, shares his presentation, titled An eye on neurodegenerative diseases: Challenging the dogma, at this year's International SPECTRALIS Symposium
At the Retina World Congress, Siegfried Priglinger, MD, speaks about ensuring the best outcomes for preschool-aged patients
At the 2025 ASCRS meeting, Robert Ang, MD said small aperture IOLs can benefit all patients, especially those with complex corneas or who have undergone previous corneal refractive surgery
Viha Vig, MBChB graduate student at the University of Auckland, New Zealand, discusses her poster presentation on the relationship between mitochondiral disease, Alzheimer disease, and other types of dementia.
© 2025 MJH Life Sciences

All rights reserved.