Inspire’s dry eye drug failed to meet primary trial end point

DURHAM, N.C. — Diquafosol, a compound in development for the treatment of dry eye, failed to meet the primary endpoint of a phase 3 clinical trial, the drug’s developer announced in a press release. The study analyzed 640 patients at 34 U.S. sites, comparing 2% diquafosol to placebo, according to Inspire Pharmaceuticals.

In this study, the drug failed to demonstrate “statistically significant improvement as compared to placebo for the primary endpoint of the incidence of corneal clearing,” Inspire said in its press release. The drug achieved statistical significance vs. placebo in several secondary endpoints, including mean corneal staining (P < .001), mean conjunctival staining (P = .002) and conjunctival clearing (P = .019), the company said.

The most common ocular side effect was burning or stinging on instillation, which occurred in fewer than 5% of patients, the company said.

In a company Web cast to discuss the results, Christy Shaffer, PhD, chief executive officer of Inspire, told analysts that the company plans to file an amended new drug application by the end of the second quarter of this year with the Food and Drug Administration, focusing more on diquafosol’s ability to achieve corneal clearing.

A separate study of use of the drug for corneal wound healing in patients undergoing LASIK should have results by the end of the year, she added.

Inspire has a partnership agreement with Allergan to market diquafosol once it receives marketing approval, the company noted. Inspire already promotes the dry eye drug Restasis (cyclosporine) and the ocular allergy drug Elestat (epinastine), both developed by Allergan.