Oyster Point completes enrollment in dry eye nasal spray trial
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Enrollment has been completed in a pivotal phase 3 trial of OC-01 nasal spray for the treatment of signs and symptoms of dry eye disease, Oyster Point Pharma announced in a press release.
The randomized, double-masked, placebo-controlled ONSET-2 trial includes 758 subjects at 22 centers in the U.S. It is investigating a 0.6 mg/mL dose and a 1.2 mg/mL dose of OC-01 nasal spray compared with placebo nasal spray, the release said.
The trial’s primary endpoint is the assessment of tear production measured by the percentage of subjects with a 10 mm or greater change in baseline Schirmer’s score after 4 weeks.
“OC-01 nasal spray represents a novel approach to treating patients with dry eye disease via a unique mechanism of action to increase natural tear film production,” Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma, said in the release. “We believe that, if approved, OC-01 nasal spray will be able to improve both signs and symptoms of dry eye disease with a favorable tolerability profile. The novel delivery of OC-01 as a nasal spray spares the ocular surface and enables our innovative mechanism of action, which would provide eye care practitioners and patients unique benefits relative to the existing standards of care.”
Topline data are expected by the end of the second quarter.