Oyster Point Pharma Announces Clinical Data Presentations on OC-01 Nasal Spray for Dry Eye Disease at the American Academy of Ophthalmology 2020 Virtual Annual Meeting
Results from the Phase 2 IMPERIAL study illustrate OC-01 nasal spray caused a decrease in goblet cell size, as compared to placebo, indicating mucin secretion after a single administration
PRINCETON, N.J., Nov. 13, 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 new data from its 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 at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting, being held on November 13-15.
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, M.D., principal investigator for the IMPERIAL study and 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.
Presentations will be available to view during the event for those registered through the following link: https://www.aao.org/annual-meeting.
About OC-01 Nasal Spray
OC-01 is a highly selective nicotinic cholinergic agonist, being developed as a preservative free nasal spray to treat the signs and symptoms of dry eye disease. The parasympathetic nervous system, the “rest and digest” system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, OC-01’s novel mechanism of action activates the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film coating is responsible for forming the primary refracting surface of the cornea, as well as protecting and moisturizing the cornea.
About Dry Eye Disease
Dry eye disease is a chronic, progressive condition that impacts more than 30 million people in the United States and is growing in prevalence. An estimated 16 million adults in the U.S. have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a person’s day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.
About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharma’s lead product candidate, OC-01 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray’s novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit.
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