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Inspire submits Special Protocol Assessment request for diquafosol
DURHAM, N.C. — Inspire Pharmaceuticals has submitted a request for Special Protocol Assessment to the U.S. Food and Drug Administration for a pivotal phase 3 environmental trial of diquafosol tetrasodium ophthalmic solution, the company announced in a press release.
The protocol follows an analysis by Inspire of all clinical data to date, including phase 3 trials and a recently completed pilot trial of Prolacria (diquafosol) for treating dry eye syndrome, as well as counsel from dry eye experts, the FDA and Allergan, Inspire's corporate partner.
After the analysis, Inspire concluded that an environmental trial was a more suitable course than additional studies of the drug in a controlled adverse environment.
The proposed environmental trial will use fluorescein staining to evaluate the effects of diquafosol on the central region of the cornea, the release said.