FDA Approves New Rx Drops for Dry Eye Disease

Decongestant Eye Drops Can Be Deadly
Decongestant Eye Drops Can Be Deadly

The FDA has approved a new drug in drops for dry eye disease, Xiidra (lifitegrast ophthalmic solution), the first medication in a new class of drugs called LFA-1 antagonists (lymphocyte function-associated antigen 1).

The disease is actually a group of conditions in which the eye does not produce a sufficient amount of tears or when the tears are not of the correct consistency. Dry eye becomes more prevalent with age as about 5% of adults between 30 and 40 and 10% to 15% of people over 65 have the ailment. It is also more common among women.

About 16 million Americans have been diagnosed with dry eye disease.

In clinical trials, the most common adverse events seen in patients (5-25%) who took the eye drops were irritation of the dry eye, reduced visual acuity and dysgeusia, a condition where a foul or metallic taste persists in the mouth. Less common side effects reported in patients (1-5%) were blurred vision, eye irritation, eye discharge, headache, sinus infection and conjunctival hyperemia, a condition where redness appears in a part of the eye.

The FDA’s approval was based on 4 randomized, placebo-controlled studies in 1,181 patients. About 75% were women. Patients were randomized to receive either Xiidra drops or placebo drops twice daily over 12 weeks. Those treated with Xiidra saw greater improvement in an eye dryness measurement over the study period compared to those given the placebo drops.

Shire, the manufacturer of Xiidra, plans to make the product available beginning in the third quarter of the year.

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