Oyster Point’s Nasal Spray for Dry Eyes Notches FDA Approval

Eye drops are most commonly used to relieve dry or itchy eyes, but how about nasal sprays? Apparently, the FDA believes that route also works, approving Oyster Point’s Tyrvaya (varenicline solution) nasal spray (0.03mg) to treat signs and symptoms of dry eye disease.

According to a 2020 Market-Scope report, dry eye disease is estimated to affect 38 million people in the US, and prevalence is rising. The disease is characterized by persistent stinging, burning sensations, blurred vision, and eye fatigue. Often people with dry eyes cannot produce enough tears or produce poor quality tears, which leads to inflammation.

Tyrvaya, now the first FDA-approved nasal spray for dry eye, works by stimulating the trigeminal parasympathetic pathway to promote tear production.

The trigeminal nerve is part of the parasympathetic nervous system which has been shown to regulate tear film homeostasis. Tyrvaya, a selective cholinergic agonist, activates the nerve from the nose, an easily accessible point. This causes the nerve to send signals to tear-secreting cells and structures in the eye, resulting in production of more basal, or “high quality”, tears.

In the Onset-1, Onset-2, and Mystic trials that enrolled over 1000 patients with mild, moderate, and severe dry eye symptoms, Tyrvaya was shown to ease dryness discomfort and increase tear film production. The studies met their primary endpoints, related to signs of the disease, with a high level of significance against the placebo. 

Sneezing is the most common side effect, reported in 82% of patients.  5-16% of patients experienced other adverse reactions ranging from cough to irritation of the nose or throat.

Following approval, the nasal spray will be available with a prescription starting next month. The drug has to be administered twice daily into each nostril.

“The approval of Tyrvaya Nasal Spray marks a milestone for patients and eye care professionals by providing a new drug treatment option for the signs and symptoms of dry eye disease with a differentiated route of administration that is believed to leverage a nerve pathway that can be accessed within the nose,” commented Jeffrey Nau, president, and CEO of Oyster Point Pharma. He further stated that the company looks forward to making the spray “available to eye care professionals and their patients.”

Ed Holland, Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati, said, “I see many patients in my practice whose lives are impacted by dry eye disease. Tyrvaya Nasal Spray is a new pharmaceutical approach with a differentiated mechanism of action for the dry eye disease community. Having a product that provides clinically meaningful production of basal tear film as early as four weeks is incredible for the dry eye patient.”

Competing Treatments for Dry Eye

Oyster Point’s first approved product is expected to compete for prescriptions with conventional eye drops, such as Novartis’ Xiidra and Abbvie’s Restasis. One advantage bringing Tyrvaya ahead would be its relatively quick onset of action, as it encourages basal tear production within 4 weeks, compared to Restasis, which takes up to 6 months for patients to see an effect.

The company’s Chief Commercial Officer John Snisarenko has said that Tyrvaya will have competitive pricing compared to Novartis’ and Abbvie’s drugs. Patients will have to pay $10 out of pocket for the drug if their insurers do not cover it, he added.

Meanwhile, medical device maker Lumenis in April obtained FDA approval for OptiLight to manage dry eye. Lumenis’ machine uses intense pulsed light (IPL) to stimulate the nerves to boost tear production. Similar to Tyrvaya, it can also be applied via the nasal route. However, the device is not as convenient as the nasal spray — patients must first be taught how to use the device at home.

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Joy Lin

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