New data from the phase 2 IMPERIAL clinical trial evaluating OC-01 (varenicline) nasal spray in the treatment of the signs and symptoms of dry eye disease in adults were presented at the AAO 2020 Virtual Annual Meeting.
A single administration of OC-01 nasal spray significantly reduced goblet cell area and perimeter as measured by in vivo confocal microscopy as compared to placebo in subjects with dry eye disease. Goblet cells in the conjunctiva are responsible for releasing mucus and, based on clinical data, may help re-establish tear film homeostasis. OC-01 nasal spray was found to be safe and well-tolerated in the study, with the most commonly reported treatment-related event being sneeze.
“The positive results from IMPERIAL add to the growing body of evidence around the safety and efficacy of OC-01 in addressing the signs and symptoms of dry eye disease, a condition that impacts the day-to-day lives of millions of adults in the United States despite current treatments,” said Pedram Hamrah, MD, principal investigator for the IMPERIAL study in a press release. Dr. Hamrah is also an ophthalmologist and cornea specialist at Tufts Medical Center, and professor of ophthalmology at Tufts University School of Medicine. “The data from this clinical study show how parasympathetic activation may stimulate mucin production at the ocular surface.”
The single-center, randomized, double-masked, placebo-controlled trial included 18 patients with dry eye disease. The objective of the study was to assess the effect of OC-01 nasal spray on goblet cell alterations by in vivo confocal microscopy (IVCM). IVCM images of the bulbar conjunctiva, the membrane covering the outer surface of the eye, taken prior to and 10 minutes after administration showed that OC-01 significantly reduced goblet cell area and perimeter in dry eye disease, indicating goblet cell degranulation, which releases lubricating mucus.
Details of the Poster Presentation
Title: OC-01 (Varenicline) Nasal Spray Induces Goblet Cell Alterations in Patients with Dry Eye Disease
Authors: Gabriela Dieckmann, M.D.; Stephanie M. Cox, O.D.; Maria J. Lopez, M.D.; M. Cunyet Ozmen, M.D.; Leyla Yavouz-Saricay, M.D.; Betul N. Bayraktutar, M.D.; William W. Binotti, M.D.; Jeffrey Nau, Ph.D., M.M.S.; Pedram Hamrah, M.D.
Abstract #: PO092
In addition to the poster presentation, Oyster Point Pharma president and CEO, Jeffrey Nau Ph.D., M.M.S., will present at the AAO Industry Showcase on Friday, Nov. 13 from 12:50 to 1:20 p.m. EST.