A phase 2b clinical trial for a novel dry eye disease treatment in the form of a nasal spray met both sign and symptom endpoints by showing significant improvement compared to a vehicle control.
The PEARL study evaluated OC-02, a nicotinic acetylcholine receptor agonist Oyster Point Pharma is developing to treat the signs and symptoms of dry eye disease.
“We think this is a fundamental therapy, what I would consider the foundational therapy of dry eye, for producing a healthy, stable tear film,” Jeffrey Nau, president and CEO of Oyster Point Pharma, told Primary Care Optometry News.
The 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.
Nau said most patients are familiar with nasal sprays, making drug delivery convenient. The drug goes right to the receptors, binds to them and potentially can cause an increase in tear film immediately and over time.
The 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 dry eye disease at U.S. centers, according to a press release from the company.
Primary endpoints included the assessment of tear production as measured by Schirmer’s score and patient-reported symptoms of dry eye as measured by the validated Eye Dryness Scale under adverse conditions.
The study compared three different doses of OC-02 to a vehicle control nasal spray.
Researchers found a dose-response in the production of tear film as measured by a statistically significant improvement in Schirmer’s score in all three doses tested compared to a control: the 2.0% dose group had a mean change in Schirmer’s score of 19.3 mm, the 1.0% dose group led to a 17.1 mm change and the 0.2% dose group yielded a mean change of 8.6 mm, respectively.
“We are excited that the drug was able to produce a pronounced dose response, which hasn't been seen with other dry eye therapies in the past,” Nau said. “There is a strong correlation with how much drug we were able to deliver vs. how much tear film was produced vs. how much reduction there was in symptoms.”
He also said OC-02 is the first pharmaceutical approach showing improvement in signs and symptoms in same trial, within the same study.
Based on the clinical data, the treatment is applicable to a broad range of patients, Nau said. “Which will allow these patients to recover from the cycle of dry eye inflammation and irritation and stop that cycle. We hope to be able to use the product to interrupt patients from getting into the cycle [of dry eye symptoms,]” Nau added.
There were no ocular adverse events or drug-related serious adverse events.
Cough and nose and throat irritation were the most common adverse events and are typical of nasal sprays, according to the release.
The treatment “should be applicable to a large population of patients with dry eye,” Nau said.
Oyster Point has a number of additional ongoing phase 2 studies that will be completed around the end of the fourth quarter of 2018, Nau said. The company is planning on an end of phase 2 meeting with the FDA at the end of the year and hopes to begin phase 3 by end of the second quarter or early third quarter of 2019. – by Abigail Sutton
Disclosure: Nau is CEO at Oyster Point Pharma.