Drug news: Prolacria heads into Phase III trials

At last! Diquafosol fans will be happy to know that Inspire are still moving forward on new trials of their Prolacria drug with the FDA's blessing despite its chequered history. I wish them the very best success in these upcoming trials.

Inspire Pharmaceuticals initiates Phase III dry eye trial
Jan 28, 2009

Inspire Pharmaceuticals has reached agreement with the FDA through a special protocol assessment on the design of a Phase III clinical trial for Prolacria 2% for the treatment of dry eye disease and has recently initiated enrollment in the trial.
Based on the special protocol assessment agreement (SPA), Inspire has initiated a Phase III, 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 US 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.