CORNEA 22 EWAP JUNE 2022 by Liz Hillman Editorial Co-Director Nothing to sniff at: Intranasal spray for dry eye Contact information de Luise: vdeluisemd@gmail.com Galor: AGalor@med.miami.edu Sheppard: jsheppard@cvphealth.com It½s not the first time the trigeminal nerve pathway or even intranasal delivery received approval as a treatment for dry eye, but clinicians are excited nonetheless about the October 2021 FDA approval of varenicline (TYRVAYA, Oyster Point Pharma), a nasal spray for the signs and symptoms of dry eye disease. According to Oyster Point Pharma, the varenicline nasal spray is “believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway, resulting in increased production of basal tear film as a treatment for dry eye disease.” The company shared that the mean change in Schirmer’s scores among patients treated with TYRVAYA vs. vehicle in the two clinical trials was 11.7 mm and 11.3 mm and 3.2 mm and 6.3 mm, respectively. It might be the first and only nasal spray approved for this indication, but preceding it was a similar concept with a different mode of action. TrueTear, which was pulled from the market by Allergan in 2020 just 2 years after its launch, also operated based on stimulation of the trigeminal nerve pathway to increase production of a complete tear film. TrueTear, however, was an intranasal neurostimulator, which used randomly generated micro-electrical impulses to drive the reaction. Vincent de Luise, MD, also mentioned the iTEAR device (Olympic Ophthalmics), still on the market, which stimulates the nasal nerve externally to increase tear production. Anat Galor, MD, said she thinks there is a place for TYRVAYA in the dry eye space. “It’s such a big market, I do think there is space for everyone,” she said, noting that there is a subset of patients who might find intranasal delivery of therapy beneficial, such as those who have difficulty with drops (administering them or the topical effects). “There are people who are sensitive to eye drops; … they find it attractive to have tearing without the local site reaction,” she said. “We know there is a trigeminal pathway that can activate a tearing response from stimulation of the anterior ethmoidal nerve in the nose. We saw a rapidly increasing tear lake.” John Sheppard, MD, MMSc, FACS, said the trigeminal nerve stimulation pathway is familiar to him, having worked on development of TrueTear with Allergan. “It worked beautifully,” he said, providing full stimulation of the lacrimal functional unit, which produced real tears with natural proportions of oil, mucin, aqueous, proteins, and other beneficial components. Targeting this pathway with TrueTear had its challenges though, such as patient acceptance, lack of insurance coverage, and a significant cohort of patients who didn’t like the tingling sensation the device caused, Dr. Sheppard said. Thus, despite what Dr. Sheppard called “tremendous intellectual investment, large amounts of investigational time, and magnificent short- and long-term results,” this neurostimulation approach was not a commercial success. It, however, established the This article originally appeared in the April 2022 issue of EyeWorld. It has been slightly modified and appears here with permission from the ASCRS Ophthalmic Services Corp.
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