FDA approves Parion’s investigational new drug application for treatment of dry eye disease

May 2 2014

Parion Sciences, a company dedicated to the development of novel treatments for ocular and pulmonary diseases, announced today that it has received acceptance from the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for P-321 Ophthalmic Solution for the treatment of dry eye disease.  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 May 6, 2014, in Orlando, Fla.

"The FDA's acceptance of our IND marks an important milestone in our ophthalmology program, as we advance P-321 into a Phase 1/2a clinical trial in subjects with dry eye disease," said Paul Boucher, President, Parion Sciences. "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."