Inspire Pharmaceuticals, Inc has submitted a clinical protocol and request for Special Protocol Assessment (SPA) to the US Food and Drug Administration (FDA) for a pivotal phase-3 environmental trial with Prolacria (diquafosol tetrasodium ophthalmic solution) for the treatment of dry eye disease.
Prolacria is an internally developed P2Y(2) receptor agonist being developed by Inspire as an eye drop that stimulates release of the three natural tear components involved in tear secretion – mucin, lipids and fluid.
The protocol is based on information from a detailed analysis of the overall Prolacria clinical trial data to date, including Inspire's phase-3 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 (dry eye chamber). 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 SPA agreement is in place, additional details on the trial design will be provided.
"We have taken a methodical approach to identify the appropriate clinical trial design for an additional phase-3 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," stated Christy L Shaffer, president and CEO of Inspire.
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases.