Oyster Point Announces Positive Results from Phase 2 Clinical Trial of Investigational Treatment for Dry Eye Disease

Oyster Point Pharma 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 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.

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,” Jeffrey Nau, PhD, CEO of Oyster Point, said in a company news release. “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.”