Oyster Point Pharma Submits a Phase 2 Clinical Trial Protocol to Evaluate OC-01 Nasal Spray for Neurotrophic Keratitis (NK)

Excerpt from the Press Release:

PRINCETON, N.J., Dec. 01, 2020 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced it has submitted to the U.S. Food and Drug Administration (FDA) a protocol to initiate a clinical study in adult patients with neurotrophic keratitis (NK), a degenerative disease characterized by decreased corneal sensitivity and poor corneal healing. The submission was made to Oyster Point’s Investigational New Drug (IND) for OC-01 (varenicline) nasal spray in dry eye disease. Enrollment of the first patient in the OLYMPIA Phase 2 study in NK is planned for the first half of 2021.

The OLYMPIA Phase 2 trial is a multi-center, randomized, double-masked, placebo-controlled study that will enroll adult subjects with NK. One-half of the adult subjects will receive one dose of OC-01 nasal spray twice daily for eight weeks; the other half will receive a placebo-controlled nasal spray. The study objective is to evaluate the safety and effectiveness of OC-01 nasal spray as compared to placebo for complete resolution of corneal staining in subjects with Stage 1 or Stage 2 NK in one or both eyes.

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