In their article entitled “Demonstration of Efficacy in the Treatment of Dry Eye Disease with 0.18% Sodium Hyaluronate Ophthalmic Solution (Vismed, Rejena),” the authors claim in the discussion section that so far, in the United States, no drug has gained Food and Drug Administration (FDA) approval for the treatment of dry eye disease (DED).

In 2002, cyclosporine ophthalmic emulsion 0.05% was approved by the United States FDA for the treatment of chronic DED, albeit for a particular subset of patients whose dry eye disease is attributable to ocular inflammation. The legal battle that followed between the manufacturing company and the FDA was related to marketing exclusivity, and not to licensing of the drug for DED.

Since clinically significant DED is associated with considerable inflammation in the majority of patients, I, therefore, believe the authors’ claim about the absence of FDA-approved topical medications for DED should be revised.