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Oyster Point begins dry eye nasal spray phase 3 trial
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Oyster Point Pharma has enrolled the first patient in a phase 3 trial of OC-01, a nasal spray treatment candidate for the signs and symptoms of dry eye disease, according to a press release.
The multicenter, randomized, double-masked, placebo-controlled ONSET-2 clinical trial will evaluate the safety and efficacy of OC-01 in two doses, 0.6 mg/mL and 1.2 mg/mL, vs. placebo in 750 subjects at 20 U.S. centers.
“We believe OC-01 has the potential to change the way that eye care practitioners treat patients with dry eye disease due to the rapid onset of action in increasing natural tear film production, the ability to significantly improve both signs and symptoms of dry eye disease, and a favorable tolerability profile,” Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point, said in the release. “The novel delivery of OC-01 as a nasal spray spares the ocular surface and enables our innovative mechanism of action, providing eye care practitioners and patients unique benefits.”
The trial’s primary endpoint will be the assessment of tear production as measured by the percentage of subjects with a 10 mm or greater change from baseline Schirmer’s score after 4 weeks.