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news.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.
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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.
The proposed environmental trial focuses on evaluating the effects of Prolacria on the central region of the cornea measured using the fluorescein staining technique. Once a final special protocol assessment (SPA) agreement is in place, additional details on the trial design will be provided.
Christy Shaffer, president and CEO of Inspire, said: “We have taken a methodical approach to identify the appropriate clinical trial design for an additional Phase III dry eye trial with Prolacria. In consultation with the FDA, we believe requesting an SPA is a prudent step forward prior to initiating this additional trial.”