Source:

Press Release

March 02, 2021
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FDA accepts NDA for dry eye nasal spray

Source:

Press Release

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The FDA has accepted a new drug application from Oyster Point Pharma for OC-01, a nasal spray treatment for the signs and symptoms of dry eye disease, according to a press release.

The submission for OC-01 (varenicline) is supported by positive safety and efficacy data from the phase 3 ONSET-2, the phase 2b ONSET-1 and the phase 2 MYSTIC clinical trials, in which more than 1,000 patients with dry eye disease demonstrated significantly significant improvement in Schirmer’s score compared with control, the release said. Secondary endpoints in the ONSET trials included change from baseline in symptoms assessed by eye dryness score.

“The FDA acceptance of our NDA for OC-01 (varenicline) nasal spray represents a major milestone towards our goal of bringing novel and potentially transformational therapies to patients with ocular surface diseases,” Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma, said in the release.

The FDA does not plan to hold an advisory committee meeting to discuss the application and has set a PDUFA target action date of Oct. 17. If the spray is approved, Oyster Point plans to launch it by the end of the year.