Tyrvaya nasal spray is used to treat dry eye disease. Tyrvaya increases natural tear production by activating the trigeminal nerves within the nose to relieve dry eye symptoms.

Dry eye disease is often a long-term condition where there are problems with the tear film that normally protects and lubricated the eyes. Dry eye disease causes symptoms of stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue, and it may lead to inflammation and damage to the cornea. Natural tears are a complex mixture of proteins, growth factors, and antibodies. Tyrvaya is used to increase the amount of natural tear film to improve the symptoms of dry eye. 

Tyrvaya (varenicline solution) is a highly selective cholinergic agonist (mode of action). Tyrvaya became an FDA-approved medicine on Oct. 18, 2021.

How effective is Tyrvaya?

Tyrvaya improved the Eye Dryness Score by -13.9 mm more than the placebo, which means that it was statistically significantly better at improving dry eyes than the placebo.

The clinical trial called ONSET-1 (NCT03636061) studied the effectiveness of Tyrvaya for dry eye. The study found that patients who used the 0.03 mg nasal spray twice daily for 28 days had a statistically significant improvement in tear film production when compared to the placebo group. The effectiveness was measured by the mean change from baseline in Eye Dryness Score. The higher the EDS score, the dryer the eyes. If the score decreases during treatment, then the eyes are less dry and more lubricated.

The results of ONSET-1 clinical trial show the mean change from baseline in Eye Dryness Score (EDS) at week 4: 

• Tyrvaya-treated patients -18.9 mm
• placebo-treated patients  -5.4 mm
• Difference between Tyrvaya patients and placebo patients was - 13.9 mm

• Use the nasal spray exactly as your healthcare provider tells you to use it.
• Tyrvaya is a nasal spray that is sprayed into the nose.
• Do not shake the bottles.
• Spray one spray into each nostril two times daily (about 12 hours apart).
• Two nasal spray bottles are a one-month supply. You should finish the first bottle before opening the next bottle.
• Click here for detailed Instructions for Use

Usual Nasal Spray dose: 

Use one spray in each nostril twice daily (approximately 12 hours apart).

Before using this medicine tell your doctor or prescriber about your medical conditions. 

Pregnancy
Tell your healthcare provider if you are pregnant, planning a pregnancy, or become pregnant. It is not known if Tyrvaya will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or are planning to breastfeed. It is not known if Tyrvaya passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

If you miss a dose, skip that dose and take your next dose at your regular scheduled time. Do not take an extra dose to make up for a missed dose.

Common Tyrvaya side effects may include sneezing (82%), cough (16%), throat (13%), and nose irritation (8%). Most side effects reported were mild, and less than 2% of patients stopped treatment in clinical trials due to side effects. 

These are not the only possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

There are no known drug interactions with Tyrvaya.

How should I use Tyrvaya?

• See the Instructions for Use at the end of this Patient Information leaflet for information about the right way to use Tyrvaya.
• Tyrvaya increases tear production in the eye after being sprayed in the nose.
• Use the nasal spray exactly as your healthcare provider tells you to use it.
• Do not shake the bottles.
• Spray 1 time in each nostril, 2 times daily (about 12 hours apart).
• A 1-month supply consists of 2 nasal spray bottles. Finish 1 bottle before opening the second.
  Tyrvaya comes in glass bottles with a white nasal pump and blue dust cover.
• If you miss a dose, skip that dose and take your next dose at your regular scheduled time. Do not take an extra dose to make up for a missed dose.

Dosing information

- Administer one spray in each nostril twice daily (approximately 12 hours apart).

Use: treatment of the signs and symptoms of dry eye disease