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FDA clears Parion's NDA for dry eye disease treatment
Parion Sciences announced it has received U.S. Food and Drug Administration acceptance for its New Drug Application for P-321 Ophthalmic Solution for the treatment of dry eye disease.
“Our program focuses on a novel mechanism of action to restore one of the core causes of the disease, the reduced tear film volume,” Paul Boucher, president, Parion Sciences said in a company announcement. “The potent and long-lasting effect of P-321 to hydrate the ocular surface could provide a needed relief to patients suffering from dry eye. We’re excited to begin clinical studies later this year.”
According to the press release, the epithelial sodium channel (ENaC) plays an important role in the regulation of tear film fluid. Studies with preclinical models of dry eye disease have shown that by blocking ENaC, the tear film volume can be restored. P-321 is Parion’s answer to develop a potent ENaC inhibitor with unique pharmacokinetic and pharmacodynamics characteristics deigned for topical ocular administration, metabolic stability and limited systemic exposure.