Oyster Point Announces Enrollment of First Subject in the OLYMPIA Phase 2 Clinical Trial for Patients with Neurotrophic Keratopathy
Oyster Point Pharma announced enrollment of the first subject in the OLYMPIA phase 2 clinical trial of OC-01 (varenicline) nasal spray for the treatment of Stage 1 Neurotrophic Keratopathy (NK).
“This is an exciting milestone as we continue to develop this potentially new treatment option for patients with Stage 1 Neurotrophic Keratopathy,” Jeffrey Nau, PhD, MMS, president and chief executive officer of Oyster Point Pharma, said in a company news release. “We believe that NK affects more patients than are currently diagnosed as the disease has the potential to be undiagnosed or misdiagnosed. Stage 1 NK patients may present with additional ocular surface issues, including dry eye disease, which affects 38 million1 patients.”
The OLYMPIA phase 2 study is a multicenter, randomized, double-masked, placebo-controlled clinical trial to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with Mackie’s Classification Stage 1 Neurotrophic Keratopathy. The study is expected to enroll approximately 100 subjects at approximately 18 U.S. sites. In this clinical trial, OC-01 (varenicline) nasal spray will be administered three times a day, as compared to placebo (vehicle) nasal spray. The pre-specified primary endpoint of the trial will be the percentage of subjects who achieve complete resolution of fluorescein corneal staining at Day 56.
“NK is characterized as a degenerative disease of the cornea due to impairment of trigeminal innervation that results in corneal epithelial damage,” said Marian Macsai, MD, chief medical officer of Oyster Point Pharma, said in the news release. “We believe that OC-01 nasal spray may activate natural tear production through the trigeminal parasympathetic pathway, bypassing the impaired corneal nerves to stimulate the production of natural tear film and potentially improve corneal sensitivity and healing.”