FDA Approves Varenicline Solution Nasal Spray for Dry Eye Disease

Officials with the FDA have approved varenicline solution (Tyrvaya; Oyster Point) nasal spray as the first and only nasal spray that treats the signs and symptoms of dry eye disease.

According to an Oyster Point press release, varenicline solution is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway, which increases production of basal tear film. The spray is a highly selective cholinergic agonist delivered twice daily into each nostril. The treatment provides a new option for patients with dry eye disease, especially those who may have difficulty administering eye drops.

“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 with the nose,” said Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma, in the press release.

The nasal spray was investigated in the ONSET-1, ONSET-2, and MYSTIC clinical trials among more than 1000 patients with mild, moderate, or severe dry eye disease. In the ONSET-1 and ONSET-2 trials, most patients were female, with a mean standard age of 61 and a mean baseline eye dryness score of 59.3. Use of artificial tears was allowed during the studies.

Investigators measured basal tear production by change from baseline in anesthetized Schirmer’s score and eye dryness was measured by change from baseline in Eye Dryness Score. According to the press release, patients treated with Tyrvaya showed statistically significant improvements in tear film production as assessed using the anesthetized Schirmer’s score at week 4.

Furthermore, 52% achieved a 10 mm or greater increase in Schirmer’s score from baseline in the ONSET-1 study and 47% achieved a 10 mm or greater increase in the ONSET-2 study, compared to 14% and 28% of vehicle-treated patients, respectively. Of the patients treated with Tyrvaya, the mean change in Schirmer’s score was 11.7 mm and 11.3 mm compared to 3.2 mm and 6.3 mm in the vehicle treated patients in the ONSET-1 and ONSET-2 studies, respectively, at week 4.

In the Controlled Adverse Environment of the ONSET-1 study, the observed mean change from baseline in Eye Dryness Score at week 3 was -16 mm in Tyrvaya-treated patients compared to -4.4 mm in vehicle-treated patients, meeting the endpoint. In the ONSET-2 trial, the observed mean change from baseline in Eye Dryness Score at week 4 was -10.3 mm in Tyrvaya-treated patients compared to -7.4 mm in vehicle-treated patients. This finding did not meet the endpoint.

The most common adverse reaction reported in 82% of patients was sneezing. According to the press release, events reported in 5% to 16% of patients included cough, throat irritation, and nose irritation. The nasal spray will be available with a prescription in November 2021.

“I see many patients in my practice whose lives are impacted by dry eye disease,” said Ed Holland, MD, director of cornea services at Cincinnati Eye Institution, in the press release. “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 4 weeks is incredible for the dry eye patient.”

REFERENCE

Oyster Point Pharma Announces FDA Approval of Tyrvaya (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease.News release. Oyster Point; October 18, 2021. Accessed October 18, 2021. https://investors.oysterpointrx.com/news-releases/news-release-details/oyster-point-pharma-announces-fda-approval-tyrvayatm-varenicline