Oyster Point Pharma announced positive results from their phase 2 Mystic trial, which evaluated OC-01 nasal spray as compared to placebo on signs of dry eye disease. The trial met the pre-specified primary endpoint which was the assessment of tear production as measured by mean change in Schirmer’s score at Day 84 as compared to vehicle control.
MYSTIC was a randomized, single-masked, vehicle-controlled clinical trial that evaluated the safety and efficacy of OC-01 in 123 subjects with Dry Eye Disease at the Asociación para Evitar la Ceguera (APEC) in Mexico City. APEC is the largest specialized ophthalmology hospital in North America by patient volume. The study compared two different doses of OC-01 nasal spray to vehicle control nasal spray (1:1:1 randomization). The goal of this study was to assess the safety and efficacy of twice daily dosing of OC-01 nasal spray administered for 84 days. Results showed a statistically significant improvement in Schirmer’s score from baseline at Day 84 in both doses as compared to control. Results for the study eye (primary endpoint) indicated:
- The 1.2 mg/ml dose had a mean change in Schirmer’s score of 11.0 mm
- The 0.6 mg/ml dose had a mean change in Schirmer’s score of 10.6 mm
- The vehicle control group had a mean change in Schirmer’s score of 6.2 mm
OC-01 nasal spray was well-tolerated at the two doses tested. The most common adverse events in the nasal spray groups were blurry vision, sneezing, and headache.
Top-line data from the Phase 3 ONSET-2 study in Dry Eye Disease are expected in mid-2020.
About OC-01 Nasal Spray
OC-01 is a highly selective nicotinic acetylcholine receptor (nAChR) agonist, being developed as a preservative free nasal spray to treat the signs and symptoms of dry eye disease (DED). The parasympathetic nervous system, the “rest and digest” system of the body, controls tear film homeostasis partially via the trigeminal nerve which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, OC-01’s novel mechanism of action activates the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film coating is responsible for forming the primary refracting surface of the cornea, as well as protecting and moisturizing the cornea.Source: Oyster Point Pharma