PRINCETON, N.J.--(BUSINESS WIRE)--Oyster Point Pharma, Inc., today announced 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 study met both sign and symptom primary endpoints by showing a statistically significant improvement in each compared to a vehicle control. Topline data from the study will be presented at the American-European Congress of Ophthalmic Surgery (AECOS) Summer Symposium in Deer Valley, Utah, on July 15, 2018.
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.
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.
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:
- 2.0% dose group had a mean change in Schirmer’s score of 19.3 mm (p<0.0001 vs. control)
- 1.0% dose group had a mean change in Schirmer’s score of 17.1 mm (p<0.0001 vs. control)
- 0.2% dose group had a mean change in Schirmer’s score of 8.6 mm (p=0.0018 vs. control)
- The control arm had a mean change in Schirmer’s score of 2.6 mm.
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:
- 2.0% dose group had a mean change in EDS score of -19.0 mm (p=0.0006 vs. control)
- 1.0% dose group had a mean change in EDS score of -16.5 mm (p=0.0067 vs. control)
- 0.2% dose group had a mean change in EDS score of -10.2 mm (p=0.46 vs. control)
- The control arm had a mean change in EDS score of -6.8 mm.
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.
“We are excited by the results of the PEARL study. Showing a statistically significant improvement in both the signs and symptoms of dry eye within the same clinical trial validates the potential of stimulating the trigeminal parasympathetic pathway with this class of compound to increase natural tear film production,” said Dr. Jeffrey Nau, CEO of Oyster Point. “These results indicate a clear dose-response to OC-02 and suggest that this novel approach can stimulate tear production in dry eye patients with a broad range of baseline severity. We look forward to the continued development of both of our compounds, OC-02 and OC-01.”
“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.”
About OC-02
OC-02 is Oyster Point Pharma’s proprietary small molecule that acts selectively as a nicotinic acetylcholine receptor (nAChR) agonist and is in Phase 2 development for the treatment of dry eye disease. OC-02 is administered with a nasal spray and is a potential first-in-class, ocular surface sparing treatment for stimulating the trigeminal parasympathetic pathway to promote natural tear film production.
About Dry Eye Disease
An estimated 16 million U.S. adults have been diagnosed with Dry Eye Disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film.1,2 A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains antimicrobials to reduce the risk of infection, and creates a smooth surface which 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, Inc.
Based in Princeton, New Jersey, Oyster Point is a clinical-stage pharmaceutical company leveraging neuroscience to discover, develop, and commercialize novel therapies to treat diseases with high unmet needs. The company’s initial focus is to develop innovative therapeutics to treat the signs and symptoms of Dry Eye Disease by stimulating the trigeminal parasympathetic pathway to activate the glands and cells responsible for tear film production, known as the Lacrimal Functional Unit. Oyster Point is leveraging a class of receptors called nicotinic acetylcholine receptors (nAChRs) which are located on the trigeminal nerve, accessible within the nose, to stimulate natural tear film production. The two lead product candidates, OC-01 and OC-02, are delivered via nasal spray and are currently in Phase 2 trials for the treatment of Dry Eye Disease.
For more information visit oysterpointrx.com and follow on Twitter at @OysterPointRx.
1 Farrand, K.F., Fridman, M., Stillman, I.O., Schaumberg, D.A. Prevalence of diagnosed dry eye disease in the United States among adults aged 18 years and older. Am J. Ophthalmol. 2017;182:90–98.
2 Craig, J.P., Nichols, K.K., Nichols, J.J., Caffery, B., Dua, H.S., Akpek, E.K. et al, TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017;15:276–283.
