A phase 2 clinical trial has delivered promising results for OC-01 nasal spray as a safe and effective treatment for patients with dry eye disease.
Developed by Oyster Point Pharma, the OC-01 is administered as a preservative-free, aqueous nasal spray, which activates the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production and re-establish tear film homeostasis.
Participants in the randomised, single-masked and vehicle-controlled study received twice-daily doses of OC-01 (varenicline), 0.6 mg/ml and 1.2 mg/ml. At 84 days, both doses showed an improvement in Schirmer’s score from baseline compared to the control group (11.0mm and 10.6mm vs 6.2mm) and were well tolerated.
“The results from the Mystic study further validate the novel mechanism of action of OC-O1 nasal spray and its ability to stimulate natural tear production via the trigeminal parasympathetic pathway,” said Associate Professor Preeya Gupta, Duke University Eye Centre and member of Oyster Point Pharma’s medical advisory board. “There is a significant need for a treatment approach that can be delivered chronically through a novel route of administration that allows patients to stimulate their own natural tear film and address the underlying disease process.”
Phase 3 clinical trials are underway with results expected mid-2020. Oyster Point Pharma said it plans to commercialise the product early 2021, pending approvals.
