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Iluvien shows similar reduction in DR progression as anti-VEGF treatment
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LAS VEGAS — Fluocinolone acetonide and anti-VEGF treatment similarly reduce progression of proliferative diabetic retinopathy, according to a presentation here.
“The duration of continuous steroid exposure during the FAME trials provides a unique opportunity to address the clinical question of the impact of corticosteroids on progression of proliferative diabetic retinopathy (PDR),” Charles C. Wykoff, MD, PhD, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology annual meeting.
Charles C. Wykoff
In the A and B arms of the phase 3 FAME study, 956 patients with diabetic macular edema (DME) were randomized to receive either 0.5 µg/day of Iluvien (Alimera Sciences), 0.2 µg/day of Iluvien or a control treatment. The FDA approved the use of 0.2 µg/day of Iluvien, designed to deliver fluocinolone acetonide for 36 months after one injection.
Based on results of the FAME study, a subanalysis of PDR in the control group vs. the treatment groups was conducted to determine whether steroids have a similar impact on the progression of PDR.
In the subanalysis, 26% of control eyes in the A trial and 31% of control eyes in the B trial progressed to PDR at 2 years and 3 years, respectively; 13% of the low-dose eyes in the A trial and 17% of the low-dose eyes in the B trial progressed to PDR at 2 years and 3 years, respectively; and 12% of the high-dose eyes in the A trials and 18% of the high-dose eyes in the B trial progressed to PDR at 2 years and 3 years, respectively (P < .001).
“In the FAME dataset involving eyes with visual acuity loss due to DME, fluocinolone acetonide treatment, with a mean of 1.3 injections over 3 years, significantly reduced progression to PDR, from 31% to 17%, a similar reduction as observed with monthly anti-VEGF treatments,” Wykoff said. — by Kristie L. Kahl
Disclosure: Wykoff reports he is a consultant for Alcon, Allergan, Bayer, Genentech, Regeneron and Thrombogenics; is a speaker for Allergan and Regeneron; and receives research support from Alcon/Novartis, Allegro Ophthalmics, Allergan, Apellis Pharmaceuticals, DRCR.net, Iconic Therapeutics, Genentech/Roche and Regeneron/Bayer.