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Marco A. Zarbin, Anthony Reder, William Collins, Gordon Francis, Xiaoli Zhang, Ludwig Y. Kappos, Jeffrey Cohen; Incidence Of Macular Edema (ME) In Fingolimod (FTY720) Multiple Sclerosis (MS) Clinical Program. Invest. Ophthalmol. Vis. Sci. 2012;53(14):6932.
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To present results of ophthalmic evaluations in the fingolimod (FTY720/Gilenya™) multiple sclerosis (MS) clinical studies. Fingolimod, 0.5 mg, once-daily, is the first approved oral therapy for relapsing forms of MS. Macular edema (ME) has been identified a safety issue of special concern in the fingolimod clinical program.
Analysis was done on pooled safety data (N=2615, All Studies group; Phase 3 core and extension studies of FREEDOMS, and TRANSFORMS, phase 2 core and extension >5 yrs). Patients with diabetes mellitus were excluded.
19 confirmed ME cases were observed (0.5 mg, n=4, 0.3%; 1.25 mg, n=15, 1.2%). Most patients (n=13, 68%) presented with blurred vision, decreased visual acuity, or eye pain. ME was diagnosed within 3-4 months of treatment initiation in most cases (n=13, 68%), two having a late onset (>12 months). 5/19 (26%) ME patients had a history of uveitis compared to 26 (1%) in the All Studies Group, suggesting uveitis may be a risk factor. In the placebo-controlled FREEDOMS study, there were slight increases in central foveal thickness from baseline mean of 169 µm were observed (0.5 mg, +4.1 µm; 1.25 mg, +5.5 µm; placebo, +0.9 µm) using OCT 3, suggesting it is a sensitive measure for early diagnosis of asymptomatic ME. In most cases (n=16, 84%), ME resolved after discontinuing study drug; none reported further vision deterioration. 9 patients received treatment with topical anti-inflammatory medication.
Fingolimod 0.5 mg is associated with a low incidence of ME in MS studies. ME generally improved or resolved with or without treatment after drug discontinuation. Patients with a history of uveitis or, based on previous studies in renal transplantation, diabetes mellitus are at increased risk.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00289978, NCT00340834
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