Xiidra Approved for the Treatment of Dry Eye Disease
July 12, 2016 – The U.S. FDA approved Xiidra™ (lifitegrast ophthalmic solution) 5% for treating the signs and symptoms of dry eye disease. Lifitegrast is a lymphocyte function-associated antigen (LAF-1) antagonist that works by down-regulating inflammation mediated by a type of white blood cell called T lymphocytes. This inflammation of the eye can cause a decrease in tear production, leading to dry eye disease. Xiidra, manufactured by Shire, will be available in foil pouches containing five 0.2mL single-use containers. The recommended dose is one drop in each eye administered twice daily, approximately 12 hours apart. Shire plans to launch Xiidra within the next few months.
Xiidra has the potential to be a blockbuster medication and will primarily compete Restasis which has a annual sales of approximately $1.6 billion. Restasis, manufactured by Allergan, gained FDA approval in December 2002 and was indicated to help increase tear production in patients with dry eyes due to underlying ocular inflammation.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.