Fingolimod (FTY-720), a sphingosine-1-phosphate receptor modulator, is the first oral agent for the treatment of relapsing forms of 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 MS’ers with relapsing-remitting MS, compared to once weekly interferon β-1a and placebo. Macular edema (swelling of the central area of the retina) was a prominent adverse event reported in these and prior studies of fingolimod. Thirteen of 2,564 (0.5%) MS’ers 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.
|Upper image is done with OCT (ocular coherence tomography), which shows a raised macular due to swelling. The lower image on the right shows you a swollen macular.|
Multiple Sclerosis Research: Fingolimod and macular oedema
16 Jan 2012; Eye examination showed clinical macular oedema (ME) in the left eye, which was confirmed on fluorescein angiogram and optical coherence tomography (OCT). After discontinuation of fingolimod and treatment with topical …