Cyclosporine Eye Drops for Dry Eye: Restasis, Cyclomune and What the Trials Show

Most dry eye products add moisture to the surface of the eye. Cyclosporine eye drops do something different: they calm the inflammation that stops the eye making enough good quality tears in the first place. That makes them one of the few treatments that target the cause of chronic dry eye rather than the symptom. It also makes them slow, and the evidence behind them is more modest than most product pages admit.

This guide explains what the drops do, what the trials actually showed, how the different products compare, including Cyclomune 0.05% and Cyclomune 0.1%, and how to use them so they have a fair chance of working.

The short answer

Cyclosporine eye drops are prescription anti-inflammatory drops for chronic dry eye. The standard regimen for Restasis and its generics is one drop in each eye twice a day, about 12 hours apart. They take months, not days: the main trials measured results at six months. In those trials, about 15 percent of patients reached the headline target of a 10 mm gain in tear production, against about 5 percent on a dummy drop, and the trials also showed improvements in corneal staining and some symptoms. Burning on instillation affects about one user in six. The 0.1% strength was not clearly better than 0.05% in the original trials. Blood levels stay essentially undetectable, so the risks are local rather than body-wide.

What cyclosporine eye drops do, and what they do not

Chronic dry eye is often driven by a cycle of inflammation on the eye surface and in the tear glands. Inflamed glands make fewer and poorer tears, and a dry surface becomes more inflamed. Cyclosporine is a calcineurin inhibitor: when taken by mouth it suppresses the immune system after transplants, but as an eye drop at low strength it acts as a local immunomodulator. The Restasis label says its exact mechanism in the eye is not known, and describes it as thought to act as a partial immunomodulator in patients whose tear production is suppressed by inflammation.

What it does not do is lubricate. Cyclosporine drops do not give the instant relief of an artificial tear, and they are not a rescue drop for a gritty afternoon. Most people keep using lubricants alongside them, especially in the first months.

The cyclosporine eye drop products

Several products contain cyclosporine for dry eye. They differ in strength, vehicle, dosing and where they are approved.

Product	Strength and form	Dosing	Where approved
Restasis and generic cyclosporine 0.05%	0.05% emulsion, preservative-free single-use vials (Restasis MultiDose also exists)	1 drop each eye twice daily, about 12 hours apart	United States (generic since 2022)
Cequa	0.09% solution	Twice daily	United States
Vevye	0.1% solution	Twice daily, about 12 hours apart	United States
Ikervis	0.1% (1 mg/mL) cationic emulsion, single-dose containers	Once daily at bedtime	UK and EU, for severe keratitis in dry eye
Cyclomune 0.05%	0.05%, 3 ml multi-dose bottle	As prescribed, usually twice daily	India, export (Sun Pharma)
Cyclomune 0.1%	0.1%, 3 ml multi-dose bottle	As prescribed	India, export (Sun Pharma)

Sun Pharma, which makes Cyclomune, is also the company behind Cequa in the US. Cyclomune itself is not approved by the FDA, the MHRA or the TGA.

What the Restasis trials showed

The Restasis label summarises four multicentre, randomised, controlled studies in about 1,200 patients with moderate to severe dry eye (keratoconjunctivitis sicca). The headline result, in the label's own words, was a statistically significant increase in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed by inflammation.

Restasis label, clinical studies	Result
Patients studied	About 1,200, moderate to severe dry eye
Timepoint for the main result	6 months
10 mm increase in Schirmer wetting, cyclosporine	About 15% of patients
10 mm increase in Schirmer wetting, vehicle	About 5% of patients
Patients on topical anti-inflammatory drugs or with punctal plugs	No increase in tear production seen
Bacterial or fungal eye infections	No increase reported

This is the part most product pages skip. A 10 mm gain on the Schirmer strip is a large change, and only about one patient in seven reached it, compared with one in twenty on the dummy drop. That is a real, statistically significant effect, but it is not a transformation for most people. Many patients improve by smaller margins on other measures, which is where the next study comes in.

Is 0.1% stronger than 0.05%?

The two identical phase 3 trials that underpin Restasis (PMID 10768324) tested both strengths. A total of 877 patients with moderate to severe dry eye were randomised to cyclosporine 0.05%, cyclosporine 0.1% or vehicle, twice daily for six months.

• Both strengths beat vehicle on two objective signs: corneal staining and categorised Schirmer values.
• The 0.05% strength also beat vehicle on three subjective measures: blurred vision, the need for artificial tears, and the doctor's global assessment of response.
• The authors reported no dose-response effect. Doubling the strength did not produce a bigger benefit.
• Both strengths had a good safety profile, with no significant topical or systemic safety findings.

That is why 0.05% became the US standard. Newer 0.1% products such as Vevye and Ikervis use different vehicles designed to deliver the drug better, and Ikervis is dosed once daily, so their strength cannot be compared number for number with an older 0.05% emulsion. Strength alone is not the story; the formulation matters as much.

Cyclomune 0.05% or Cyclomune 0.1%?

For most people starting treatment, the evidence supports 0.05%, taken twice daily, as the default. It matches the strength of Restasis and its generics, and the original trials found no extra benefit from 0.1% in the same type of vehicle. An eye doctor may prefer 0.1% for more severe surface disease, or when copying a regimen used with Vevye or Ikervis. Do not switch strengths or frequency on your own because the drops seem slow; slowness is expected, and doubling up is not supported by the evidence and is likely to add to the burning.

How long before cyclosporine eye drops work?

Expect months. The main trial results were measured at six months, and the UK Ikervis labelling asks prescribers to reassess response at least every six months. Some people notice less grittiness or less reliance on artificial tears within a few weeks, but a fair trial is three to six months of consistent twice daily use. A common reason these drops seem to fail is stopping in the first month, because they sting and nothing seems to be happening yet.

How to use cyclosporine eye drops properly

1. Wash your hands. If the product is an emulsion, turn the vial or bottle upside down a few times until it looks uniformly white.
2. Remove contact lenses first. They can go back in 15 minutes after the drop.
3. Pull the lower lid down gently and instil one drop, without touching the tip to the eye, lashes or any surface.
4. Repeat in the other eye, about 12 hours after the previous dose for twice daily products.
5. If you use artificial tears or other eye drops, leave 15 minutes between products.
6. Single-use vials are opened and discarded after each dose, even if some liquid remains.

Chilling is not needed for Restasis, which the label says to store at 15 to 25 degrees Celsius. For Cyclomune and other bottles, follow the carton's storage and discard-after-opening instructions.

Burning and other side effects

The Restasis label reports ocular burning as the most common adverse reaction, at 17 percent. Other reactions in 1 to 5 percent of patients were redness of the eye surface, discharge, watering, eye pain, foreign body sensation, itching, stinging and blurred vision. After approval, rare hypersensitivity reactions including eye and face swelling were reported, along with superficial eye injuries from the vial tip touching the eye.

Newer formulations report different figures. In the Vevye label, based on 738 trial subjects, instillation site reactions affected 8 percent and temporary reductions in visual acuity 3 percent. Trials of different products are not directly comparable, but the pattern is consistent: the drops can be uncomfortable, and the discomfort is local.

Burning often eases as the eye surface heals over the first weeks. If it is intolerable, talk to your eye doctor rather than simply stopping; options include a different formulation or a short supporting treatment.

Does the drug get into the rest of the body?

Very little. In the Restasis label, blood cyclosporine levels in every sample over up to 12 months of twice daily use were below the measurable limit of 0.1 ng/mL, with no accumulation. The Vevye label reports the same finding. For comparison, people taking oral cyclosporine after an organ transplant are monitored at blood levels hundreds of times higher. This is why cyclosporine eye drops do not carry the kidney and blood pressure warnings of the tablets.

Using cyclosporine with artificial tears

Lubricants and cyclosporine work well together, as long as you leave 15 minutes between them. A reasonable pattern is cyclosporine morning and night, with a lubricant during the day as needed. Options include Refresh Tear (carboxymethylcellulose), Trehalube (sodium hyaluronate), Moisol (hypromellose) and, for night-time, the thicker GenTeal gel. The label notes that people using punctal plugs in the trials did not show increased tear production on cyclosporine, which is worth discussing with your eye doctor if you already have plugs.

Steroid drops as a starting bridge

Because cyclosporine is slow, eye specialists sometimes combine it with a short course of a mild steroid drop at the start, such as loteprednol or fluorometholone, then continue cyclosporine alone for long-term control. Steroid eye drops can raise eye pressure and contribute to cataract with prolonged use, so they belong under medical supervision with pressure checks, not in open-ended self-treatment. The label observation that patients already on topical anti-inflammatory drugs did not show increased tear production is another reason these decisions should sit with a clinician.

Cyclosporine with glaucoma drops

The Ikervis labelling notes limited experience in people with glaucoma and advises regular monitoring, particularly with beta blocker drops, which can themselves reduce tear secretion. Several glaucoma drops also contain preservatives that irritate the eye surface. If you use both types, space them at least 15 minutes apart and tell whoever manages your glaucoma. Our guide to glaucoma eye drop types explains which classes are involved.

Who should not use cyclosporine eye drops

• Anyone with a known allergy to cyclosporine or any ingredient in the formulation.
• Anyone with an active or suspected eye or eyelid infection, a contraindication in the Ikervis labelling.
• People with a history of herpes eye infection should use it only with caution and specialist supervision.
• Children: safety and effectiveness of Restasis have not been established below age 16.

Older adults showed no overall difference in safety or effectiveness in the Restasis trials.

Pregnancy and breastfeeding

Because cyclosporine eye drops are not detected in the blood after normal use, the Restasis label states that use in pregnancy is not expected to expose the baby to the drug. For breastfeeding, the label notes that the presence of cyclosporine in milk after eye use has not been studied and advises caution. Discuss either situation with your doctor before starting.

Bottles vs single-use vials

Restasis vials are sterile, preservative-free and single-use, which removes the risk of contaminating a bottle over weeks of use. Multi-dose bottles such as Cyclomune are more convenient and far cheaper, but need more care: never touch the tip, keep the cap on, and throw the bottle away on the date the carton gives after opening, even if some remains. If you have a very sensitive eye surface, ask whether the product contains a preservative.

How long does a 3 ml bottle last?

The Restasis label puts one drop at about 28 microlitres. On that basis a 3 ml bottle holds roughly 100 drops. At one drop per eye twice a day, that is four drops a day, or roughly three and a half to four weeks of use, before allowing for drops that miss the eye. In practice, plan on one bottle per month and replace it when the carton's after-opening limit is reached, whichever comes first.

What it costs

In the US, retail prices for generic cyclosporine 0.05% vials were around $265 for 30 vials and $523 for 60 vials in 2026, with discount card prices much lower, from roughly $50 to under $100 for a month at some pharmacies. Brand Restasis costs more. Insurance coverage varies. Internationally, Cyclomune 0.05% and 0.1% sit at a small fraction of those prices; ours are listed in the eye care range.

US readers should note that generic cyclosporine eye drops are commercially available domestically, and that a US Customs rule with an October 22, 2026 compliance date changes how international mail containing prescription medicines is processed. Check the current position before ordering from abroad.

Warning signs that need prompt care

• Eye pain that does not settle, or any sudden change in vision.
• A sticky or coloured discharge, which may suggest infection.
• Swelling of the eyelids, face, lips or tongue, or difficulty breathing.
• Redness that is worsening rather than improving after the first few weeks.

For other eye treatments and how to buy them safely, see our guide to buying eye care medicine online safely.

References

• Restasis (cyclosporine ophthalmic emulsion) 0.05%, US prescribing information: sections 1, 2, 4, 5.1, 5.2, 6.1, 6.2, 8.1, 8.2, 8.4, 11, 12.3, 14 and 16
• Vevye (cyclosporine ophthalmic solution) 0.1%, US prescribing information: sections 1, 2, 5, 6.1 and 12.3
• Ikervis 1 mg/mL eye drops, emulsion: UK Summary of Product Characteristics (electronic Medicines Compendium), sections 4.1 to 4.4
• Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group. PMID 10768324

Medical disclaimer: this article is for information only and is not medical advice. Cyclosporine eye drops are prescription medicines. Chronic dry eye has several causes, and some need different treatment, so get an eye examination before starting. Seek prompt care for eye pain, a change in vision, discharge or facial swelling.