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Published: 09/23/08 09:00 AM EDT
Inspire Pharmaceuticals, Inc. (ISPH) announced today it has submitted a clinical protocol and request for Special Protocol Assessment (SPA) to the U.S. 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.
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, Ph.D., President and CEO of Inspire.
About Prolacria™ and Dry Eye
Prolacria is an internally developed P2Y2 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. Inspire estimates, based on an extrapolation from U.S. data, that dry eye disease affects over 30 million people in the eight major international prescription pharmaceutical markets, of which over nine million are in North America. Inspire filed an NDA with the FDA in 2003 for Prolacria for the treatment of dry eye disease and has received two approvable letters from the FDA.
Inspire Pharmaceuticals, Inc. (ISPH) announced today it has submitted a clinical protocol and request for Special Protocol Assessment (SPA) to the U.S. 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.
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, Ph.D., President and CEO of Inspire.
About Prolacria™ and Dry Eye
Prolacria is an internally developed P2Y2 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. Inspire estimates, based on an extrapolation from U.S. data, that dry eye disease affects over 30 million people in the eight major international prescription pharmaceutical markets, of which over nine million are in North America. Inspire filed an NDA with the FDA in 2003 for Prolacria for the treatment of dry eye disease and has received two approvable letters from the FDA.
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