Tuesday, September 26, 2006

New Study Shows Restasis Offers no Dry-Eye Relief following LASIK

Previously the FDA, after reviewing Restasis data from a large prospective, randomized, double-masked, vehicle-controlled clinical trial involving over 1,200 patients, concluded that Restasis (cyclosporine 0.05%) has no effect on dry-eye symptoms or surface staining (data and FDA discussion available in full at www.fdarestasisdata.org).

Now a new study reports that Restasis has no effect on patient symptoms (as indicated by the Ocular Surface Disease Index Questionaire) or surface staining, verses control, in the dry eye that results after LASIK. The prospective, double-masked, placebo-controlled clinical trial of Restasis has been published in the Journal of Cataract and Refractive Surgery (Salib GM; McDonald MB; Smolek M: Safety and efficacy of cyclosporine 0.05% drops versus unpreserved artificial tears in dry-eye patients having laser in situ keratomileusis. J Cataract Refract Surg 2006 May;32(5):772-8).

Cyclosporine is an immunosuppressant that suppresses inflammation. This paper adds to the accumulating evidence that ocular surface inflammation does not contribute to dry-eye patient symptoms, and suggests that patients looking for dry-eye relief after LASIK should look to other therapies.