FDA-Approved Dry Eye Treatments: Which Uses Are Approved?
Compare FDA-approved dry-eye medicines and their labeled uses, including Tryptyr, plus how OTC tears and device clearance differ from drug approval.
U.S. FDA-approved prescription treatments for dry eye include Restasis, Cequa, Vevye, Xiidra, Miebo, Eysuvis, Tyrvaya and Tryptyr. Their approved uses differ: some increase tear production, several treat dry-eye signs and symptoms, and Eysuvis is limited to short-term treatment.
Approval is not a ranking of which treatment works best. The useful question is whether the medicine’s approved use—and the problem it targets—matches your eye examination.
Last reviewed for U.S. treatment information: November 4, 2026.
Prescription treatments and their approved uses
In labeling, signs are findings an examiner can measure, such as staining that shows damage to the eye’s surface. Symptoms are what you feel, such as dryness or discomfort. “Keratoconjunctivitis sicca” is a medical term for dry eye.
The product-name links below lead to prescribing information. These are labeled regimens, not instructions to start treatment yourself.
| Treatment | FDA-approved use, in plain language | Labeled dosing |
|---|---|---|
| Restasis: cyclosporine emulsion 0.05% | Increases tears when tear production is presumed to be suppressed by inflammation associated with dry eye | One drop in each eye twice daily, about 12 hours apart |
| Cequa: cyclosporine solution 0.09% | Increases tear production in people with dry eye | One drop in each eye twice daily, about 12 hours apart |
| Vevye: cyclosporine solution 0.1% | Treats the signs and symptoms of dry-eye disease | One drop in each eye twice daily, about 12 hours apart |
| Xiidra: lifitegrast solution 5% | Treats the signs and symptoms of dry-eye disease | One drop in each eye twice daily, about 12 hours apart |
| Miebo: perfluorohexyloctane solution 100% | Treats the signs and symptoms of dry-eye disease | One drop four times daily into affected eye(s) |
| Eysuvis: loteprednol etabonate suspension 0.25% | Treats dry-eye signs and symptoms for up to two weeks | One to two drops in each eye four times daily |
| Tyrvaya: varenicline nasal spray | Treats the signs and symptoms of dry-eye disease | One spray in each nostril twice daily, about 12 hours apart—not an eye drop |
| Tryptyr: acoltremon solution 0.003% | Treats the signs and symptoms of dry-eye disease | One drop in each eye twice daily, about 12 hours apart |
The Restasis label also notes that increased tear production was not seen in patients already taking topical anti-inflammatory drugs or using punctal plugs. That is a limitation of the reported benefit, not a direction to stop another treatment yourself.
FDA-approved generic versions of Restasis also exist. Restasis, Cequa and Vevye contain the same active drug but have different concentrations and formulations; they are not three names for one identical product.
Tryptyr joined the U.S. options on May 28, 2025. Its approval does not mean it replaces older treatments.
What makes these options different?
Dry eye can involve too little tear production, tears evaporating too quickly, or tears that do not work properly. The National Eye Institute says treatment depends on the cause.
- Inflammation-related treatment: Cyclosporine products and lifitegrast act on immune or inflammatory pathways. Their shared role does not make their formulations or approved indications identical. (Restasis label, Xiidra label)
- Evaporation: Miebo forms a layer at the tear-film surface that is expected to reduce evaporation. Its label says the exact mechanism in dry-eye disease is unknown; this is different from directly unblocking eyelid oil glands. (Miebo label)
- Tear stimulation: Tyrvaya is believed to activate a nerve pathway through the nose. Tryptyr stimulates TRPM8 receptors—cold-sensitive receptors associated with tear production. Both labels note uncertainty about the exact mechanism in dry eye. (Tyrvaya label, Tryptyr label)
Eysuvis is a corticosteroid, not an open-ended maintenance drop. Steroids can raise eye pressure, delay healing or worsen certain infections. Its initial prescription requires an eye examination, and renewal requires examination and an eye-pressure evaluation. Do not extend or restart a course on your own. (Eysuvis safety information)
Are over-the-counter artificial tears FDA-approved?
Many OTC lubricating drops are legally marketed under an FDA monograph rather than individually approved through a drug application. A monograph sets conditions for ingredients, strengths, labeling and use. Meeting that framework is different from FDA approving a particular branded dry-eye medicine. (FDA regulatory pathways, ophthalmic monograph)
That does not make artificial tears an inferior choice for everyone. They are the most common treatment for mild dry eye, according to the National Eye Institute. Their labeling generally concerns lubrication and temporary relief of dryness-related burning or irritation—not the same approved uses as the prescriptions above. For practical selection, see how to choose dry-eye drops.
What about office procedures?
Medical devices have separate FDA pathways, including 510(k) clearance, De Novo classification and premarket approval. Clearance and approval are not interchangeable terms. (FDA explanation)
For a heat- or light-based procedure, ask the clinic for the exact device name, its FDA decision and its labeled indication. A claim about one device is not authorization for every similar procedure or every cause of dry eye. Our IPL treatment guide addresses candidacy and procedure-specific questions.
Safety checks before choosing
Tell your prescriber about contact lenses, other eye drops, pregnancy or breastfeeding, and any history of glaucoma or eye infection. None of the prescription eye drops in the table should be applied while wearing contacts. Their linked labels require a 15-minute wait before reinsertion, except Miebo, which requires at least 30 minutes. Follow the instructions for your exact product.
Ask what side effects to expect and when treatment will be reassessed. For example, Tryptyr’s label reports pain on instillation in 50% of treated trial participants, while Tyrvaya commonly causes sneezing. Trial percentages from different products cannot establish which is best tolerated for you. (Tryptyr label, Tyrvaya label)
This is general information, not a diagnosis or prescription. Seek same-day eye care for sudden vision changes, eye pain or significant light sensitivity rather than assuming the problem is dry eye. These can signal a more serious eye problem. (Urgent symptom guidance)