Severe early bilateral macular edema following fingolimod therapy

We report a case of bilateral macular edema (ME) within 10 days of starting fingolimod 0.5 mg therapy in a patient with Multiple Sclerosis (MS). The complication resolved without treatment as demonstrated by sequential Optical Coherence Tomography (OCT). Fingolimod is a sphingosine-1-phosphate receptor modulator that reduces lymphocyte presence in the CNS. In pivotal trials, ME, a known complication of fingolimod, typically occurred unilaterally with onset at approximately 3 months. A 60 y/o AA female, diagnosed with MS in 1977, started oral fingolimod treatment on 05/31/2011. Baseline screening with OCT and ophthalmology evaluation showed no ME. On 06/10, she developed bilateral blurry vision and discontinued fingolimod. On 06/27, OCT revealed severe bilateral ME. Later OCT exams showed a progressive decrease in Central Foveal Thickness (CFT) and Macular Volume (MV), without specific treatment other than discontinuation of fingolimod. On 7/27, CFT, MV, and Visual Acuity (VA) were similar to baseline. This is the first reported case of bilateral, early onset ME following fingolimod treatment at the current FDA-approved dose of 0.5 mg. Diabetes, a known risk factor for ME, may have contributed to her early, bilateral involvement. Our case provides further support for earlier OCT, in conjunction with ophthalmic examinations, for at-risk patients on fingolimod, and suggests that cessation of fingolimod may be associated with resolution of ME.