Data on ocular complications were gathered from two phase 3 FDA clinical trials for Gilenya (fingolmod, Novartis) the first oral medication approved by the FDA for relapsing-remitting Multiple Sclerosis.
A 2-year trial compared Gilenya with placebo and a 1 year trial compared Gilenya with interferon beta-1a. Gilenya reduced MS relapse rate and increased the percentage of patients without an MS relapse in both studies.
“The macular edema issue is one that we as ophthalmologists are very familiar with and most neurologists are not familiar with,” Robert C. Sergott, MD of Wills Eye said. “It’s our obligation then to help them take care of these patients because we have an intersection of MS with a medication that can cause visual loss.”
In the 2-year trial, macular edema occurred in 0.4% of patients treated with Gilenya and 0.1% of patients who received placebo, Dr. Sergent said. Patients should undergo ophthalmic examinations prior to the start of the medication as well as approximately 3 or 4 months after initiation of Gilenya therapy. Patients with diabetes mellitus or history of uveitis who are placed on Gilenya should have regular dilated ophthalmic exams to include color testing and OCT.
“MS Drug may Increase Risk of Macular Edema in Patients with Diabetes, Uveitis” Ocular Surgery News April 25, 2011: 16
Cynthia Matossian, MD