Oyster Point files new drug application for dry eye nasal spray
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Oyster Point Pharma submitted a new drug application to the FDA for its nasal spray to treat signs and symptoms of dry eye disease, according to a press release.
OC-01 (varenicline) binds to the trigeminal nerve when administered in the nasal cavity. The binding triggers the parasympathetic nervous system, initiating the production of all three layers of tear film, Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point, told Healio/OSN.
“It works fairly immediately, so the patient can basically treat themselves with their own natural tear film,” Nau said.
The application is based on safety and efficacy data from three trials that evaluated the therapy in more than 1,000 patients with dry eye disease, according to the release.
“We think that it is very well differentiated among the marketplace,” Nau said. “Most of the therapies for dry eye are drops or gels or ointments that need to be applied to the surface of the eye.”
The application method may also help with therapy adherence compared with drops and gels, Nau said.
“This NDA allows us to build out one of the more important capabilities that Oyster Point will bring to the ophthalmology space,” Nau said.
In the MYSTIC, ONSET-1 and ONSET-2 studies, OC-01 showed statistical significance in improvement in Schirmer’s scores. All doses in the studies were well tolerated and presented no serious drug-related adverse events.
“I’m really excited for the opportunity not only to launch OC-01 in the latter part of the year, but also to do clinical development or business development to put more products into our sales teams’ hands,” Nau said.
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