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MS drug may increase risk of macular edema in patients with diabetes, uveitis
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 Robert C. Sergott |
PHILADELPHIA — A newly approved multiple sclerosis drug poses a potential risk of macular edema in patients with diabetes mellitus and a history of uveitis, a speaker said here.
"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, said at the Wills Eye Institute Alumni Conference. "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."
Gilenya (fingolimod, Novartis) is the first oral medication approved by the U.S. Food and Drug Administration for relapsing-remitting MS. The active ingredient regulates lymphocyte distribution and is believed to thwart lymphocyte migration from the lymph nodes and into the central nervous system.
Data on ocular complications were culled from two phase 3 FDA clinical trials for fingolimod. A 2-year trial compared fingolimod with placebo, and a 1-year trial compared fingolimod with interferon beta-1a, Dr. Sergott said.
Fingolimod was administered in 0.25-mg and 1.25-mg doses.
Fingolimod reduced the MS relapse rate and increased the percentage of patients without an MS relapse in both studies. The differences were statistically significant (P < .001).
In the 2-year trial, macular edema occurred in 0.4% of patients treated with fingolimod and 0.1% of patients who received the placebo, Dr. Sergott said.
Patients should undergo ophthalmic examination 3 or 4 months after initiation of fingolimod therapy; patients with diabetes mellitus or history of uveitis should have regular ophthalmic exams, Dr. Sergott said.
Visual acuity should be monitored at baseline and during routine exams, he said.
- Disclosure: Dr. Sergott reported financial relationships with Novartis and Biogen Idec.
Only a few drugs cause retinal side effects such as macular edema and fingolimod (Gilenya), the newly FDA approved oral medicine for treating multiple sclerosis, should be added to the list for ophthalmologists to keep in mind. For the average patient on the medicine, the incidence is low and so routine screening is not necessary. It just needs to be considered as a potential source for decreased vision in a patient on the medicine. It gets more challenging in patients with diabetes or uveitis in which the underlying disease itself may cause macular edema. Therefore, the medicine should be ruled out as a potentially precipitating or exacerbating factor with the macular edema before instituting local therapies such as intraocular steroid or anti-VEGF injections or focal laser photocoagulation.
– Carl D. Regillo, MD
OSN Retina/Vitreous
Board Member
Disclosure: Dr. Regillo reported no relevant financial
relationships.