Oyster Point Pharma, Inc. has announced recent results from the PEARL study, a Phase 2b clinical trial evaluating the company’s novel therapy for the treatment of Dry Eye Disease (DED). The therapy stimulates the parasympathetic nervous system via the trigeminal nerve through a prescription nasal spray. The study met both sign and symptom primary endpoints by showing a statistically significant improvement in each compared to a vehicle control.
The PEARL study was a dose-ranging, randomized, double-masked, vehicle-controlled clinical trial that evaluated the safety and efficacy of OC-02 in 165 subjects with DED at U.S. centers. Primary endpoints included the assessment of tear production as measured by Schirmer’s score, which is a test of the eye’s ability to produce tears, and patient-reported symptoms of DED as measured by the validated Eye Dryness Scale (EDS) under adverse conditions. The study compared three different doses of OC-02 to a vehicle control nasal spray.The study evaluated OC-02, a nicotinic acetylcholine receptor (nAChR) agonist the company is developing to treat the signs and symptoms of DED. The OC-02 compound is delivered as a nasal spray and stimulates the trigeminal parasympathetic pathway to activate the glands responsible for producing the eye’s natural tear film.
Among the findings, results indicated a clear dose-response in production of tear film as measured by a statistically significant improvement in Schirmer’s score in all three doses tested compared to a control. In addition, there was a statistically significant reduction of symptoms as measured by a reduction in EDS score in the two highest doses tested compared to a control.
OC-02 was well-tolerated with no ocular adverse events or drug-related serious adverse events. The most common adverse events were typical of nasal sprays and included cough, and nose and throat irritation. These events were predominantly mild, transient and self-limiting.
“There is a significant unmet need for effective dry eye treatments that offer immediate results and a favorable safety profile,” said Dr. Edward Holland, Professor of Ophthalmology, University of Cincinnati and Oyster Point Pharma’s medical advisory board member. “These preliminary findings are an encouraging step forward for this novel pharmaceutical that could change how we approach the treatment of Dry Eye Disease.”
See the full news release from Oyster Point Pharma, Inc.
Source: Oyster Point Pharma, Inc.