Inspire Pharmaceuticals, Inc. has reached an agreement with the FDA through a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical trial for Prolacria(TM) (diquafosol tetrasodium ophthalmic solution) 2% for the treatment of dry eye disease and has recently initiated enrollment in the trial. Based on the SPA agreement, Inspire has initiated a Phase 3, randomized, placebo-controlled, environmental clinical trial to evaluate the efficacy and safety of Prolacria in approximately 450 subjects with dry eye who have a fluorescein staining score of three in the central region of the cornea at baseline, using the National Eye Institute (NEI) scale of zero to three. Subjects will be randomized to Prolacria or placebo administered as eye drops four times daily for six weeks at approximately 60 U.S. and Canadian sites. The agreed upon primary efficacy endpoint is the proportion of subjects receiving Prolacria that achieve clearing of fluorescein staining of the central region of the cornea in the study eye (a score of zero on the NEI scale) at the six-week trial endpoint, compared to those receiving placebo. The FDA indicated, as part of the SPA review process, that even if this trial is successful, the FDA’s review of Prolacria will also take into account the robustness of the trial results, that a surrogate endpoint was used, the results from previous Prolacria trials and the overall risk/benefit. Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented, “We are pleased to have reached agreement with the FDA on the parameters for an additional Prolacria clinical trial. Our decision to continue development of Prolacria is based on a number of factors, including: the dry eye market is large and growing, with only one commercially available prescription product; our analysis of related Prolacria historical data in the central region of the cornea; and the length and estimated costs of this trial are reasonable relative to the financial opportunity.” “We selected clinical trial sites and investigators experienced in conducting dry eye trials and evaluating dry eye patients using fluorescein staining procedures. We have worked closely with the sites to standardize the staining evaluation process,” Dr. Shaffer concluded.
