Is Tyrvaya nasal spray FDA approved? Your guide to this dry eye treatment

October 9, 2025 •

4 min read

On October 15, 2021, the U.S. Food and Drug Administration (FDA) approved Tyrvaya (varenicline solution) nasal spray, marking the first nasal spray treatment for dry eye disease. So, is Tyrvaya nasal spray FDA approved? Yes, and it offers a novel approach for patients who find using eye drops challenging.

Quick Summary

Tyrvaya is an FDA-approved nasal spray for treating the signs and symptoms of dry eye disease. It works by stimulating natural tear production via a nerve pathway in the nose, offering a unique alternative to traditional eye drops.

Key Points

FDA Approval: Yes, Tyrvaya nasal spray was approved by the FDA on October 15, 2021, for the treatment of dry eye disease.
Unique Mechanism: Instead of drops, Tyrvaya is a nasal spray that activates a nerve pathway in the nose to stimulate the body's natural tear production.
Proven Efficacy: Clinical trials showed that nearly half of patients on Tyrvaya experienced a significant increase in tear production after four weeks of use.
Common Side Effects: The most common side effects are sneezing, cough, and nose or throat irritation, which are typically mild and temporary.
Administration: The spray is administered once in each nostril, twice daily, and requires a specific technique to ensure proper delivery.
Alternative to Eye Drops: Tyrvaya provides a non-ocular, preservative-free alternative for patients who have difficulty with or haven't found relief from traditional eye drops.

What is Tyrvaya and how does it work?

Tyrvaya, with the generic name varenicline solution, is a prescription nasal spray used for the treatment of dry eye disease (DED). Administered through the nose, Tyrvaya utilizes a unique delivery method compared to conventional eye drops.

The mechanism behind natural tear production

Tyrvaya acts on the trigeminal parasympathetic pathway, a neural connection between the nasal cavity and the glands responsible for tear production. By stimulating these nerves intranasally, Tyrvaya prompts the body to increase its own natural tear film production. This differs from artificial tears which provide temporary external moisture; Tyrvaya aims to activate the body's natural tear production process. The resulting tear film includes aqueous, lipid, and mucin layers, vital for eye health and comfort.

Clinical evidence supporting FDA approval

Tyrvaya's FDA approval was based on clinical trial data, including the phase 3 ONSET-2 study, involving participants with moderate to severe dry eye disease. The primary measure of efficacy in these trials was the change in Schirmer's Test Score (STS), which assesses tear production.

Clinical trials showed that Tyrvaya significantly improved tear production compared to a placebo:

In the ONSET-1 and ONSET-2 studies, a notable percentage of patients using Tyrvaya achieved a ≥10-mm increase in STS from baseline, significantly higher than those on placebo.
Some patients reported symptom relief, such as reduced eye dryness, within three to four weeks.
Rapid increases in tear production were observed as early as five minutes after the initial dose in some cases.

These clinical results supported the FDA's decision to approve Tyrvaya for adults with dry eye disease. The FDA's official approval package provides further details.

How to properly use Tyrvaya nasal spray

Correct administration of Tyrvaya is essential for optimal results and minimizing side effects. The manufacturer provides the acronym TEAR as a guide:

Tilt: Angle the applicator toward the ear on the side of the nostril being sprayed. Avoid spraying directly upward into the sinuses.
Elevate: Raise your tongue to the roof of your mouth.
Administer: Press the applicator completely to deliver one spray.
Resist: Do not inhale the mist deeply, as the medication is absorbed by the nasal wall.

Dosage and handling instructions

Dosing: Apply one spray to each nostril twice daily, about 12 hours apart.
Priming: Before initial use, prime the bottle by spraying seven times into the air. If unused for over five days, re-prime with one spray.
Storage: Keep the bottle at room temperature and avoid shaking.
Missed dose: Skip a missed dose and take the next scheduled dose. Do not take a double dose.

Common side effects of Tyrvaya

Clinical trials identified several common side effects associated with Tyrvaya, primarily related to its nasal delivery.

Sneezing: This was the most frequent side effect, reported by a large majority of patients (82%), and was generally described as mild and brief. No participants stopped treatment due to sneezing.
Cough: Approximately 16% of patients experienced a cough.
Throat Irritation: Irritation in the throat was reported by 13% of trial participants.
Nose Irritation: This affected 8% of patients.

Serious side effects are uncommon. Systemic exposure to the active ingredient, varenicline, is significantly lower with Tyrvaya compared to the oral formulation (Chantix). Proper use according to the TEAR method can help minimize some common side effects.

Comparison of Tyrvaya with other dry eye treatments

Tyrvaya's mechanism of action distinguishes it from other dry eye treatments. The table below compares Tyrvaya with common alternatives like artificial tears and prescription eye drops (e.g., cyclosporine).


Feature	Tyrvaya (varenicline nasal spray)	Artificial Tears (OTC drops)	Prescription Eye Drops (e.g., Restasis)
Mechanism	Stimulates natural tear production via a nasal nerve pathway.	Provides temporary lubrication and moisture to the eye.	Works as an immunosuppressant to gradually increase tear production.
Administration	One spray per nostril, twice daily, into the nose.	Drops applied directly to the eyes, potentially multiple times daily.	Drops applied directly to the eyes, usually twice daily.
Onset of Action	Some report increased tears quickly; significant improvement over weeks.	Immediate, temporary relief.	Results typically take several weeks or months.
Potential Issues	Common side effects include sneezing, cough, throat, and nose irritation. Requires specific administration technique.	Frequent use may be needed; does not address root cause.	Can cause initial burning; takes time to show effect.
Ideal for	Patients preferring a non-ocular method or struggling with drops. Targets tear production deficits.	Mild or occasional dry eye; used as a first step.	Patients with chronic dry eye linked to inflammation.
Insurance	Often needs prior authorization; manufacturer offers savings programs for commercially insured patients.	Typically not covered.	Varies by plan; prior authorization often required.

Is Tyrvaya nasal spray FDA approved? The verdict

Yes, Tyrvaya nasal spray received FDA approval in October 2021 to treat dry eye disease. It represents a novel approach in dry eye treatment by stimulating the body's own tear production through a nasal route, offering an alternative to traditional eye drops. Clinical trials have demonstrated its effectiveness in increasing tear production, making it a new option for managing dry eye symptoms.

Conclusion

Tyrvaya stands as an innovative treatment for dry eye disease, offering a non-ocular method to encourage natural tear production by targeting a specific nerve pathway in the nose. This provides a potentially longer-lasting benefit than temporary solutions like artificial tears. While common, side effects such as sneezing and throat irritation are typically mild and manageable with correct usage. Individuals with dry eye disease should consult their eye care professional to determine if Tyrvaya is a suitable option for their treatment plan.

Frequently Asked Questions

No, Tyrvaya is a prescription medication and is not available over-the-counter. It must be prescribed by an eye care professional.

Some patients experience increased tear production within minutes of the first dose. Significant improvement in signs and symptoms of dry eye may be noticed after several weeks of consistent use.

Yes, Tyrvaya is safe to use with contact lenses in, as it is administered via the nose and does not require application to the eye's surface.

Insurance coverage varies, and many plans require a prior authorization. The manufacturer also offers savings programs for eligible commercially insured patients to reduce out-of-pocket costs.

If you miss a dose, simply skip it and take your next dose at your regularly scheduled time. Do not double the dose to catch up.

Artificial tears provide temporary moisture and lubrication to the eye's surface. Tyrvaya works by stimulating your body to produce its own natural tears, addressing the underlying issue of insufficient tear production.

The manufacturer recommends using the TEAR method: Tilt the tip toward the ear, Elevate the tongue, Administer the spray, and Resist inhaling the mist.