New dry eye drug approved for clinical trial

Parion Sciences announced FDA approval of its Investigational New Drug application for an epithelial sodium channel-inhibiting ophthalmic solution (P-321) for dry eye. The company plans to start phase 1/2 clinical trials later this year.

Pre-clinical studies show that blocking the epithelial sodium channel restores tear film volume.

“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.”