Preclinical data that supported this approval will be presented in a poster session at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO) on 6 May 2014, in Orlando, Florida.
Parion Sciences president Paul Boucher noted that the FDA’s acceptance of the company’s IND marks an important milestone in its ophthalmology program, as it advances P-321 into a Phase I/IIa clinical trial in subjects with 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. 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," Boucher added.
The epithelial sodium channel (ENaC) plays a key role in the regulation of tear film fluid and is therefore an attractive target for the treatment of dry eye. Studies with preclinical models of dry eye disease have demonstrated that by blocking ENaC, the tear film volume is restored, maintaining its protective and lubricating actions on the ocular surface.
P-321 is the result of a comprehensive research effort to develop a potent ENaC inhibitor with unique pharmacokinetic and pharmacodynamics characteristics designed for topical ocular administration, metabolic stability and limited systemic exposure. Parion Sciences has completed all the preclinical safety and mechanistic studies required to initiate clinical studies in humans.