Oyster Point Pharma enrolls first subject in phase 2 clinical trial of OC-01 nasal spray for neurotrophic keratopathy

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Oyster Point Pharma announced today the enrollment of the first participant in its OLYMPIA phase 2 clinical trial of OC-01 (varenicline) nasal spray to treat stage 1 neurotrophic keratopathy (NK).


Oyster Point Pharma announced today the enrollment of the first participant in its OLYMPIA phase 2 clinical trial of OC-01 (varenicline) nasal spray to treat stage 1 neurotrophic keratopathy (NK).

The trial — a multicenter, randomized, double-masked, placebo-controlled clinical trial — is expected to enroll an estimated 100 subjects at approximately 18 sites across the U.S., according to a company news release.

OC-01 (varenicline) nasal spray is designed as a multidose, preservative-free nasal spray to treat signs and symptoms of NK and dry eye disease (DED).

Participants will receive OC-01 (varenicline) nasal spray administered three times a day, as compared to a placebo (vehicle) nasal spray. The trial's pre-specified primary endpoint will be the percentage of subjects who reach complete resolution of fluorescein corneal staining at Day 56, the company reports.

“We believe that OC-01 nasal spray may activate natural tear production through the trigeminal parasympathetic pathway, bypassing the impaired corneal nerves to stimulate the production of natural tear film and potentially improve corneal sensitivity and healing," said Marian Macsai, MD, Oyster Point Pharma's chief medical officer, in a statement.

After receiving acceptance by the U.S. FDA for its NDA of OC-01 (varenicline) nasal spray earlier this year, the company's target action date for the Prescription Drug User Fee Act (PDUFA) is Oct. 17, 2021.

A U.S. launch of the nasal spray is planned for the fourth quarter, pending FDA approval.