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

Oyster Point Pharma announced it has submitted to the FDA a protocol to initiate a clinical study in adult patients with neurotrophic keratitis (NK). 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 multicenter, 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 8 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.

“Neurotrophic keratitis is the second of a number of important indications we are evaluating with OC-01 nasal spray, illustrating Oyster Point’s commitment to treating unmet needs related to ocular surface diseases,” Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma, said in a company news release. “In preclinical and clinical studies, OC-01 has been shown to stimulate natural tear film, via a novel pathway found in the nasal mucosa, which allows the bypassing of corneal neuron stimulation of the tear film. We look forward to working with the FDA to advance this important study into the clinic.”

In addition to NK, Oyster Point remains on track to file its new drug application (NDA) for OC-01 to treat the signs and symptoms of dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film, in the fourth quarter of 2020.