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    Nasal Spray for Dry Eye Comes to Market

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    The first nasal spray developed to treat dry eye disease (DED) is now available. In the phase 3 trial known as ONSET-2, researchers found that varenicline (Tyrvaya; Oyster Point Pharma) promoted tear film produc­tion and significantly improved the signs and symptoms of DED.1

    The medication was developed to pharmacologically activate the trigemi­nal nerve in the nasal cavity, noted lead author David Wirta, MD, at the Eye Re­search Foundation in Newport Beach, California. And the delivery method provides a new option for patients, par­ticularly those who may have difficulty administering eyedrops.

    Study design. ONSET-2 included 758 patients who were randomized 1:1:1 to a nasal spray containing either placebo (n = 252), varenicline .6 mg/mL (n = 260), or varenicline 1.2 mg/mL (n = 246). All participants were 22 years of age or older and had an Ocular Surface Disease Index score of 23 or more and a Schirmer test score of 10 mm or less.

    Participants self-administered the spray twice daily in each nostril for four weeks. They assessed their symptoms using the Eye Dryness Score (EDS) at clinic visits and in a controlled adverse environment (CAE) chamber that simulates everyday situations known to exacerbate dry eye symptoms.

    Results. At week 4, the percentage of patients who achieved a 10-mm im­provement or more in their Schirmer score was 47.3% of those who received varenicline .6 mg/mL, 49.2% of those in the 1.2 mg/mL varenicline cohort, and 27.8% of those who received placebo.

    The EDS improved with vareni­cline, as measured during clinic visits, although the improvement had limited clinical significance. In addition, the advent of the COVID-19 pandemic restricted the use of the CAE chamber. In a subgroup analysis, tear film pro­duction improved regardless of baseline anesthetized Schirmer score tear pro­duction or baseline EDS severity.

    Adverse events. The most common adverse event was sneezing: Nearly all patients on varenicline sneezed at least once during treatment, particu­larly during the first minute following administration.

    With regard to potential safety issues, Dr. Wirta noted that since 2006, varenicline has been used at much higher doses by over 20 million patients worldwide as an aid for smoking ces­sation. “It’s rare to have as much safety data available for a medication at the time of approval,” he said.

    Clinical implications. Treatment du­ration will depend upon the individual patient, Dr. Wirta said. He added, “As dry eye disease is a chronic multifacto­rial disease, we expect that patients will take the medication for the duration of their disease.”

    —Miriam Karmel

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    1 Wirta D et al. Ophthalmology. Published online Nov. 10, 2021.

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    Relevant financial disclosures—Dr. Wirta: Oyster Point Pharma: C,S.

    For full disclosures and the disclosure key, see below.

    Full Financial Disclosures

    Dr. Jeffery None.

    Dr. Liebmann Allergan: C; Diopsys: O; Galimedix Thera­peutics: C,O; Genentech: C; Infocus Capital Partners: C; NEI: S; Qura: C,O; Sustained Nano Systems: C,O,P; Thea Pharmaceuticals: C.

    Dr. Rosenfeld Apellis: C,O; Bayer: C; Carl Zeiss: C,S; Boeh­ringer Ingelheim: C; Chengdu Kanghong Bio­tech: C; Gyroscope Therapeutics: S; OcuDyne: C,O; Ocunexus (inflammX): C; Regeneron: C; Stealth BioTherapeutics: S; Unity Biotechnolo­gy: C; Valitor: O; Verana Health: O.

    Dr. Wirta AbbVie: S; Aerie: C,S; Allergan: C,S; Allysta: S; Bausch + Lomb: S; Eyenovia: C,S; Jennivision: S; Nicox: S; Novaliq: S; Novartis: C,S; Ocuphire: S; Ora: S; Orasis: S; Osmotica: S; Oyster Point Pharma: C,S; Qlaris: S; Santen: C,S; TearCare: S; Tersus: S; Visus: S.

    Disclosure Category

    Code

    Description

    Consultant/Advisor C Consultant fee, paid advisory boards, or fees for attending a meeting.
    Employee E Employed by a commercial company.
    Speakers bureau L Lecture fees or honoraria, travel fees or reimbursements when speaking at the invitation of a commercial company.
    Equity owner O Equity ownership/stock options in publicly or privately traded firms, excluding mutual funds.
    Patents/Royalty P Patents and/or royalties for intellectual property.
    Grant support S Grant support or other financial support to the investigator from all sources, including research support from government agencies (e.g., NIH), foundations, device manufacturers, and/or pharmaceutical companies.

     

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