Oyster Point Pharma has announced the initiation of the OLYMPIA Phase 2 clinical trial of its OC-01 varenicline nasal spray for the treatment of neurotrophic keratopathy. The company’s NDA for OC-01 for the treatment of dry eye disease is currently under review by the FDA.
The OLYMPIA study is expected to enroll approximately 100 patients with Stage 1 neurotrophic keratopathy who will get either OC-01 three times a day or placebo. According to the company’s web site, Oyster Point is also has a gene therapy treatment for the treatment of neurotrophic keratopathy that includes OC-01 nasal spray in preclinical development.
Oyster Point Chief Medical Officer Marian Macsai explained, “NK is characterized as a degenerative disease of the cornea due to impairment of trigeminal innervation that results in corneal epithelial damage. 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.”
President and CEO Jeffrey Nau commented, “This is an exciting milestone as we continue to develop this potentially new treatment option for patients with Stage 1 neurotrophic keratopathy. 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 million patients.”
Read the Oyster Point Pharma press release.
