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12 Jul 2016

USFDA approved Xiidra (lifitegrast ophthalmic solution) for dry eye disease

  • Brand Name: Xiidra
  • Molecule: lifitegrast ophthalmic solution
  • Drug Class: Lymphocyte function-associated antigen 1 (LFA-1) antagonist
  • Approved for: Dry Eyes
  • Manufactured By: Shire US Inc
The safety and efficacy of Xiidra was assessed in over a thousand patients, in four separate, randomized, controlled studies. These studies included patients 19–97 years of age, of which the majority were female (76 percent). Patients were randomized equally to receive either Xiidra eyedrops or placebo eyedrops, which were used twice a day for twelve weeks. The studies found that groups treated with Xiidra demonstrated more improvement in both the signs and the symptoms of eye dryness than the groups treated with placebo.
The most common side effects of Xiidra include eye irritation, discomfort or blurred vision and an unusual taste sensation (dysgeusia).
Dry eye disease does not routinely occur in children. Safety and efficacy in pediatric patients below the age of 17 years has not been studied.

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