Prolacria (diquafosol tetrasodium ophthalmic solution) for dry eye disease failed in clinical studies, said Inspire Pharmaceuticals.
Trial using 2% diquafosol tetrasodium 03-113 was a six-week, randomized, placebo-controlled trial in 490 patients who had a fluorescein staining score of three in the central region of the cornea at baseline, using the National Eye Institute scale of zero to three.
The primary endpoint was the proportion of subjects receiving Prolacria, administered four times daily as eye drops, that achieved clearing, or a staining score of zero, in the central region of the cornea in the study eye at the six-week trial endpoint, compared to those receiving placebo.
The secondary endpoint was the proportion of patients receiving Prolacria (diquafosol) that achieved greater than or equal to a two-unit reduction in staining scores at the six-week trial endpoint, compared to those receiving placebo.
“We have provided the top-line results from this trial to our partner Allergan and we will be conducting a thorough review of the program before determining next steps, if any,” stated Christy L. Shaffer, Ph.D., President and CEO of Inspire.
Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases.
Inspire’s most advanced compounds in clinical pipeline are Prolacria (diquafosol tetrasodium ophthalmic solution) 2% for dry eye and denufosol tetrasodium for cystic fibrosis, which are both in Phase 3 development, and Azasite (azithromycin ophthalmic solution) 1% for blepharitis, which is in Phase 2 development.
Inspire receives revenues related to the promotion of Azasite for bacterial conjunctivitis, the co-promotion of Elestat (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and royalties based on net sales of Restasis (cyclosporine ophthalmic emulsion) 0.05% for dry eye.