No abstract

Diquafosol tetrasodium was well tolerated and was superior to placebo (vehicle) in reducing corneal staining and in relieving certain patient symptoms. Diquafosol has a favorable risk/benefit profile in a broad spectrum of patients with dry eye disease and is a novel topical treatment of dry eye.

The InflammaDry test demonstrates a high positive and negative agreement for confirming suspected dry eye disease. In addition, the test was safely and effectively performed by untrained operators. These findings support the intended use of the InflammaDry test as an aid in the diagnosis of dry eye.

The results of this study indicate that the Test Product significantly reduced corneal and conjunctival staining, indicating a reduction in disease severity. Evaluations of ocular staining scores provide clinically meaningful evidence of dry eye severity and are an important indicator of dry eye disease progression.

The fixed combination of bimatoprost 0.03%/timolol 0.5% administered once daily was comparable in ocular hypotensive efficacy to the non-fixed combination. The lower propensity of the fixed combination to elicit conjunctival hyperemia suggests a superior comparative benefit/risk assessment of the fixed combination in the treatment of elevated IOP.