The wait is over: FDA approves nasal spray TYRVAYA for dry eye disease

TYRVAYA is the first and only nasal spray approved for treating dry eye disease and could provide significant relief for many dry eye sufferers. The medication is now available with a prescription.

After years of research, testing, and clinical trials, Oyster Point Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved TYRVAYA, (varenicline solution) Nasal Spray 0.03 mg for treating the signs and symptoms of dry eye disease. Oyster Point Pharma has been expecting to hear from the FDA this past week, and now the wait is finally over.

TYRVAYA, formerly known as OC-01, is believed to bind to cholinergic receptors in the nose to help activate the parasympathetic nervous system, thus increasing basal tear production to improve the signs and symptoms of dry eye disease. This medication provides a new and convenient way to administer dry eye treatment without further irritating the ocular surface. Many patients struggle to consistently use eye drops throughout the day, and therefore, TYRVAYA’s nasal administration may provide a new level of relief for those suffering with the condition.

In the company press release today, Jeffrey Nau, the CEO of Oyster Point Pharma commented:

In any therapeutic area, it’s always an exciting moment when you follow the science and develop a truly innovative pharmaceutical treatment option for patients that addresses an important unmet medical need. In conjunction with the FDA, it has been an honor to work alongside my colleagues at Oyster Point to bring TYRVAYA Nasal Spray to the dry eye disease community.

Jeffrey Nau, Ph.D., MMS, president and CEO of Oyster Point Pharma

The FDA approval comes after years of research and clinical trials (ONSET-1, ONSET-2, MYSTIC) in over 1,000 patients, which helped to prove the medication’s safety and efficacy for commercialization. Of patients treated with TYRVAYA in clinical trials, the mean change in Schirmer’s score was 11.7 mm and 11.3 mm as compared to 3.2 mm and 6.3 mm in the vehicle treated patients at week 4. The most common adverse reaction was sneezing, which occurred in 82% of patients taking the medication. In 5-16% of patients, cough, throat irritation, and nose irritation were reported.

TYRVAYA Nasal Spray will be available with a prescription in November 2021.

The TYRVAYA Nasal Spray will be available with a prescription this November 2021 in two multidose nasal spray bottles. Each nasal spray bottle will provide treatment for 15 days when used twice per day, 12 hours apart, in each nostril. Samples for eye care professionals providing treatment for 15 days will also be made available.

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.

Ed Holland, M.D., Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati

Patients can start reaching out to their eye care providers for more information on TYRVAYA. Prescribing information, patient information, instructions for use, and details on costs and savings support can be found by visiting tyrvaya.com.