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February 27, 2012

Fingolimod-associated macular edema
Incidence, detection, and management

February 28, 2012 issue
78 (9) 672-680

Abstract

Fingolimod (FTY-720), a sphingosine-1-phosphate receptor modulator, is the first US Food and Drug Administration (FDA)–approved oral agent for the treatment of relapsing forms of multiple sclerosis (MS). Two recent phase III clinical studies (TRANSFORMS [Trial Assessing Injectable Interferon vs FTY720 Oral in RRMS] and FREEDOMS [FTY720 Research Evaluating Effects of Daily Oral Therapy in MS]) demonstrated a significant reduction in the annualized relapse rate in patients with relapsing-remitting MS, compared to once weekly interferon β-1a and placebo. Macular edema was a prominent adverse event reported in these and prior studies of fingolimod. Thirteen of 2,564 (0.5%) patients treated with fingolimod in FREEDOMS and TRANSFORMS developed macular edema. Fingolimod-associated macular edema (FAME) appears to be dose-dependent (observed in only 2 patients taking the FDA-approved 0.5 mg dose) and typically resolves upon cessation of therapy. Although a relatively common condition in ophthalmology, most neurologists have not encountered macular edema in clinical practice. The purpose of this review is to educate the neurologist on the etiology, clinical manifestations, diagnostic modalities, and treatment approaches in patients with FAME. We also discuss the use of fingolimod in patients with uveitis and diabetes mellitus, highlight the guidelines for surveillance ophthalmic examination, and outline the key distinguishing features between FAME and optic neuritis.

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Information & Authors

Information

Published In

Neurology®
Volume 78Number 9February 28, 2012
Pages: 672-680
PubMed: 22371414

Publication History

Received: June 7, 2011
Accepted: September 23, 2011
Published online: February 27, 2012
Published in print: February 28, 2012

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Disclosure

Dr. Jain reports no disclosures. Dr. Bhatti has received consultancy fees, speaker fees, or honoraria from Pfizer Inc, EMD Serono, Inc., Novartis, and Bayer Schering Pharma.

Authors

Affiliations & Disclosures

Nieraj Jain, MD
From the Departments of Ophthalmology (N.J., M.T.B.) and Medicine (Division of Neurology) (M.T.B.), Duke Eye Center and Duke University Medical Center, Durham, NC.
M. Tariq Bhatti, MD
From the Departments of Ophthalmology (N.J., M.T.B.) and Medicine (Division of Neurology) (M.T.B.), Duke Eye Center and Duke University Medical Center, Durham, NC.

Notes

Study funding: Funded in part by a departmental grant from Research to Prevent Blindness, Inc.
Correspondence & reprint requests to Dr. Bhatti: [email protected]

Author Contributions

Dr. Jain: drafting/revising manuscript for content. Dr. Bhatti: conception of review, drafting/revising manuscript for content, study supervision.

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