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Phase 3 trial of dry eye treatment fails to meet primary, secondary endpoints

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DURHAM, N.C. — A phase 3 clinical trial evaluating the efficacy of diquafosol tetrasodium ophthalmic solution for treating patients with dry eye has failed to meet the primary and secondary endpoints of significantly clearing the central region of the cornea and reducing staining scores by at least two units, according to a press release from Inspire Pharmaceuticals, the developer of the drug.

The randomized, placebo-controlled study, known as Trial 03-113, enrolled 490 dry eye patients who received either Prolacria (diquafosol tetrasodium ophthalmic solution 2%) four times daily or placebo for a 6-week duration.

"We have provided the top-line results from this trial to our partner Allergan and we will be conducting a thorough review of the program before determining next steps, if any," Christy L. Shaffer, PhD, president and CEO of Inspire, said in the release.