Inspire update on Prolacria (diquafosol)
Inspire initiates special protocol assessment process for dry eye trial
Inspire Pharmaceuticals, a biopharmaceutical company, has submitted a clinical protocol and request for special protocol assessment to the FDA for a pivotal Phase III environmental trial with Prolacria for the treatment of dry eye disease.
The protocol is based on information from a detailed analysis of the overall Prolacria clinical trial data to date, including Inspire's Phase III trials and recently completed pilot trial, and consultation with the FDA, Allergan, Inspire's corporate partner, and other dry eye experts.
After detailed analysis, Inspire determined that designing and conducting a further environmental trial was a more appropriate course than further studies of Prolacria in a controlled adverse environment.