An update on the status of this potential new dry eye therapy.

For the last 13 years, Restasis (0.05% cyclosporine ophthalmic emulsion, Allergan) has reigned as the only FDA-approved prescription pharmaceutical product for the treatment of dry eye disease. Technically, it is indicated “to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.” Since the launch of Restasis in 2003, numerous companies have filed Investigational New Drug (IND) applications for similar consideration by the FDA, including anakinra, bromfenac, diquafosol, ecabet sodium, isunakinra (EBI-005), lifitegrast, rebamipide, tavilermide (MIM-D3) and tofacitinib. Yet only two of these—diquafosol and lifitegrast—have yielded clinical trials successful enough to warrant submission of a New Drug Application (NDA). Inspire Pharmaceuticals filed an NDA for diquafosol in mid-2003, but despite additional studies, subsequent amendments and numerous discussions with the FDA, the drug was never approved in the US. Merck acquired Inspire and its holdings in 2011, but has made no additional attempts to gain FDA approval of diquafosol. 

Dr. Dexter's Take

For the past several years, Restasis has been the only ocular medication approved by the FDA indicated for the treatment of dry eye disease. Several other medications by different pharmaceutical companies have gone through investigations and trials, but none have been able to make it to market yet. However, there is one new drug, Lifitegrast, that seems to be getting closer and closer to approval for use in the United States. Lifitegrast's mechanism of action involves disruption of the inflammatory cascade that results in tissue damage and subsequent ocular irritation in patients with dry eye disease. Keep an eye out for more information on this potential new tool for treating your dry eye patients! 

Read the full article from Review of Optometry