Oyster Point Pharma touted data today from two Phase IIb trials assessing its nasal spray products for the treatment of dry eye disease.
Both studies showed that use of OC-01 and OC-02 led to improvements in multiple measures of eye dryness symptoms, according to the Princeton, N.J.-based company.
Oyster Point’s Onset study evaluated the safety and efficacy of OC-01 in 182 people with dry eye disease. The trial compared three doses of OC-01 nasal spray – 0.2%, 0.1% and 0.02% – against a vehicle control nasal spray. The pre-specified primary endpoint was the assessment of tear production as measured by Schirmer’s score after 28 days.
The study’s two pre-specified secondary endpoints were patient-reported symptoms of dry eye disease after 21 and 28 days. The trial results showed a statistically significant improvement in Shirmer’s score after 28 days for all three doses of OC-01 compared to the control.
Both pre-specified secondary endpoints were also met with statistical significance, Oyster Point reported.
In the Rainier study, 53 people with dry eye disease were studied to evaluate the safety and efficacy of the company’s 2.0% OC-02 nasal spray. The trial’s pre-specified endpoint was the assessment of tear production as measured by Schirmer’s score after 28 days.
The study found that the use of OC-02 triggered an increase in tear film production, which was measured by an improvement in Schirmer’s score after 28 days compared to the control.
Both OC-01 and OC-02 were well-tolerated, Oyster Point touted, and there were no significant ocular adverse events. The most common adverse events included mild sneezing and coughing, which resolved following administration.
“The results announced today demonstrate the potential clinical benefits of the innovative therapeutics Oyster Point Pharma is developing,” Dr. Edward Holland, an ophthalmology professor at the University of Cincinnati and a member of Oyster Point’s medical advisory board, said in prepared remarks. “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.”
“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,” CEO Jeffrey Nau added. “We look forward to initiating a Phase III program in dry eye disease in 2019 after discussion with regulatory authorities.”