–Two Lead Clinical Candidates are Delivered as a Nasal Spray to Stimulate the Trigeminal Parasympathetic Pathway to Promote Natural Tear Film Production–
PRINCETON, New Jersey – October 24, 2018 – Oyster Point Pharma, Inc., today announced results from the ONSET and RAINIER studies, two separate Phase 2b clinical trials evaluating the company’s novel therapies for the treatment of Dry Eye Disease (DED). Both studies, being presented tomorrow at the Ophthalmology Innovation Summit (OIS) meeting in Chicago, demonstrated improvement in Schirmer’s score and multiple measures of eye dryness symptoms.
“The results announced today demonstrate the potential clinical benefits of the innovative therapeutics Oyster Point Pharma is developing,” said Dr. Edward Holland, Professor of Ophthalmology, University of Cincinnati and member of Oyster Point Pharma’s medical advisory board. “There is a significant need for a novel treatment approach for Dry Eye Disease. A therapeutic that can help patients to produce their own natural tear film has the potential to benefit a broad population of patients with Dry Eye Disease.”
The ONSET study was a dose-ranging, randomized, double-masked, vehicle-controlled Phase 2b clinical trial that evaluated the safety and efficacy of OC-01 in 182 subjects with DED in the United States. The study compared three different doses of OC-01 nasal spray to vehicle control nasal spray (1:1:1:1 randomization). The pre-specified primary endpoint was the assessment of tear production as measured by Schirmer’s score at Day 28 and the two pre-specified secondary endpoints were patient-reported symptoms of DED as measured by the Eye Dryness Scale (EDS) at Day 21 and Day 28.
Results showed a statistically significant improvement in Schirmer’s score at Day 28 in all three doses compared to control. Results indicated:
- 0.2% dose had a mean change in Schirmer’s score of 11.4 mm (p<0.001 vs. control);
- 0.1% dose had a mean change in Schirmer’s score of 11.8 mm (p<0.001 vs. control);
- 0.02% dose had a mean change in Schirmer’s score of 10.0 mm (p<0.001 vs. control).
- Vehicle control had a mean change in Schirmer’s score of 3.2 mm.
Results were similar in the fellow eyes (p<0.001).
Both pre-specified secondary endpoints were also met, as indicated by a statistically significant improvement in mean change in EDS score in a controlled adverse environment at Day 21 (p<0.05), and a statistically significant improvement compared to control (p<0.05) in the mean change in EDS score at Day 28 without use of a controlled adverse environment.
“We are excited about the ability for both of our investigational compounds to show improvements in both the signs and symptoms of Dry Eye Disease,” said Dr. Jeffrey Nau, CEO of Oyster Point Pharma. “We look forward to initiating a Phase 3 program in Dry Eye Disease in 2019 after discussion with regulatory authorities.”
The RAINIER study was a randomized, double-masked, vehicle-controlled, Phase 2b clinical trial that evaluated the safety and efficacy of 2.0% OC-02 nasal spray in 53 subjects (2:1 randomization) with DED in the United States. The study’s sole pre-specified endpoint was the assessment of tear production as measured by Schirmer’s score at Day 28. Results demonstrated an increase in tear film production as measured by an improvement in Schirmer’s score in the study eye at Day 28 compared to vehicle control:
- OC-02 arm had a mean change in Schirmer’s score of 10.3 mm (p=0.08 vs. control)
- Vehicle control had a mean change in Schirmer’s score of 5.9 mm
Results were similar in the fellow eyes (p<0.05).
Although not powered to show statistical significance on exploratory symptoms endpoints, OC-02 showed improvements in mean EDS and Ocular Discomfort Score (ODS) compared to vehicle control.
OC-01 and OC-02 were well-tolerated with no significant ocular adverse events or drug-related serious adverse events. Adverse events were similar in both studies. The most common adverse events included sneeze, cough, and nose and throat irritation. These events were mild, self-limiting, and resolved immediately following administration.
About OC-01 and OC-02
OC-01 and OC-02, Oyster Point’s lead product candidates, are nicotinic acetylcholine receptor (nAChR) agonists that bind specifically to receptors on the trigeminal nerve and are currently in Phase 2 development for the treatment of Dry Eye Disease. Both compounds are administered as a nasal spray and are potential first-in-class, ocular surface-sparing treatments designed to stimulate 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.1,2 Loss of tear film homeostasis is a unifying characteristic for all patients with Dry Eye Disease.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 a persistent sensation of dryness, 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 oysterpoint.wpengine.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.