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:
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.
“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.”
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
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.
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