DME implant on course for 2010 approval

Article

The two Phase III trials of Iluvien (fluocinolone acetonide; Alimera Sciences Inc) in diabetic macular oedema (DME) have been assessed for safety and efficacy by an independent Data Safety Monitoring Board and are to progress without change.

The two Phase III trials of Iluvien (fluocinolone acetonide implant; Alimera Sciences) for the treatment diabetic macular oedema (DME) have been assessed for safety and efficacy by an independent Data Safety Monitoring Board and are to progress without change. If outcomes continue to be positive, the manufacturers hope to submit the agent for approval within the next two years.

Iluvien, a therapeutic that is implanted intravitreally with a 25G needle, is available in two doses, designed to be effective for 24 and 36 months. The double-masked, multicentre trials finished enrolling patients in October 2007; the trials are designed to study the effect of the drug in patients from the US, Canada, Europe and India (n=956) for 36 months, with initial safety and efficacy follow-up at 24 months.

Newsletter

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

Recent Videos
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.
Alfredo Sadun, MD, PhD, chief of Ophthalmology at the Doheny Eye Institute, University of California Los Angeles, shared exciting new research with the Eye Care Network during the Association for Research in Vision and Ophthalmology (ARVO) meeting on the subject of Leber hereditary optic neuropathy (LHON).
Related Content
© 2025 MJH Life Sciences

All rights reserved.