Oyster Point Pharma has announced that separate Phase 2b studies of its OC-01 and OC-02 nicotine acetylcholine receptor (nAChR) agonist nasal sprays for the treatment of dry eye disease both showed improvement in dry eye symptoms for patients using the nasal sprays.
Positive results for a previous Phase 2b trial of OC-2 were announced in July 2018. Oyster Point announced in June 2018 that the FDA had cleared its IND for OC-1.
The ONSET study compared 3 doses of OC-01 to a vehicle control in 182 subjects over 28 days and found a statistically significant improvement in tear production at day 28 as measured by Schirmer’s score for all 3 doses. The secondary endpoints of improvement in patient-reported dry eye symptoms at day 21 and day 28 were also met.
The RAINIER study, which compared a single dose of OC-02 to a vehicle control in 53 subjects, met its only pre-specified endpoint, which was tear production as measured by Schirmer’s score at 28 days. Patient-reported dry eye symptoms also improved.
Data from ONSET showed mean changes in Schirmer’s score ranging from 10 mm to 11.4 mm for the 3 doses of OC-01 compared to a mean change of 3.2 mm for the vehicle control nasal spray. In the RAINIER study, OC-02 produced a mean change of 10.3 mm compared to a mean change of 5.9 mm for the vehicle control. Both nasal sprays were well tolerated, with no serious adverse events.
Oyster Point Pharma CEO Jeffrey Nau said, “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. We look forward to initiating a Phase 3 program in dry eye disease in 2019 after discussion with regulatory authorities.”
Read the Oyster Point Pharma press release.
