From the Guidelines
Cyclosporine is a recommended treatment option for severe dry eyes, as it has been shown to increase tear production and reduce inflammation in the tear glands, with noticeable benefits often appearing after several weeks of consistent use 1.
Key Points to Consider
- The most commonly prescribed form of cyclosporine for dry eyes is Restasis (cyclosporine ophthalmic emulsion 0.05%) or Cequa (cyclosporine ophthalmic solution 0.09%), typically administered as one drop in each affected eye twice daily, approximately 12 hours apart.
- Patients should expect to use the medication consistently for at least 3-6 months, as cyclosporine works gradually to increase tear production by reducing inflammation in the tear glands.
- When applying, remove contact lenses if present, wait 15 minutes before reinserting them, and avoid touching the dropper tip to any surface to prevent contamination.
- Common side effects include temporary burning or stinging upon application, which usually diminishes with continued use.
- Cyclosporine works by inhibiting T-cell activation and inflammatory cytokine production in the lacrimal glands, addressing the underlying inflammatory component of dry eye disease rather than just providing temporary lubrication.
Supporting Evidence
- A study published in Ophthalmology in 2024 found that topical cyclosporine 0.05% demonstrated a statistically significant 10-mm increase in Schirmer test results compared with vehicle at 6 months for those patients whose tear production was presumed to be decreased because of ocular inflammation 1.
- Another study published in British Journal of Dermatology in 2024 recommended the use of topical ciclosporin eyedrops for severe keratitis in dry eye disease that has not responded to treatment with tear substitutes 1.
Important Considerations
- Cyclosporine may be a disease-modifying agent for dry eye syndrome, and its use may be suitable for dermatologists to initiate under agreed local pathways.
- The dose can be decreased to once a day in a portion of the patients after 1 full year of twice-daily therapy without a decrease in beneficial effects.
- A well-planned, long-term, large clinical trial is needed to better assess the effects of topical cyclosporine as a possible disease-modifying agent.
From the FDA Drug Label
CLINICAL PHARMACOLOGY Mechanism of Action Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. Clinical Evaluations Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation.
Cyclosporine can be used for severe dry eyes associated with keratoconjunctivitis sicca, as it has been shown to increase tear production in some patients. Key points include:
- Increased tear production was seen in approximately 15% of patients treated with RESTASIS ophthalmic emulsion versus approximately 5% of vehicle-treated patients.
- This effect was seen in patients whose tear production was presumed to be suppressed due to ocular inflammation.
- No increase in bacterial or fungal ocular infections was reported following administration of RESTASIS 2.
From the Research
Cyclosporine for Severe Dry Eyes
- Cyclosporine is an immunomodulatory drug that has been used to treat severe dry eye disease, with studies showing its efficacy in improving symptoms and ocular surface health 3, 4, 5.
- A study published in 2007 compared the efficacy of topical cyclosporine, punctal occlusion, and a combination of both for the treatment of dry eye, and found that all treatments improved Schirmer scores, with plug-containing regimens favored at 1 and 3 months 3.
- Another study published in 2012 discussed the use of cyclosporin A for the treatment of dry eye, highlighting its anti-inflammatory effects and the development of new delivery systems such as microspheres, implants, and liposomes to enhance its efficiency 4.
- A review of clinical evidence published in 2015 summarized the use of cyclosporine ophthalmic emulsions for the treatment of dry eye, and found that cyclosporine emulsion consistently decreased corneal staining and increased Schirmer scores, with symptom improvement being more variable 5.
- A systematic review published in 2019 assessed the effectiveness and safety of topical cyclosporine A for the treatment of dry eye, and found that the evidence was inconsistent, with some studies showing improvements in symptoms and ocular surface parameters, while others did not 6.
- A study published in 2014 discussed the safety and efficacy of cyclosporine in the treatment of chronic dry eye, and found that cyclosporine was a useful treatment option, with numerous studies showing its safety and efficacy 7.
Key Findings
- Cyclosporine has been shown to improve Schirmer scores and decrease corneal staining in patients with dry eye 3, 5.
- The use of cyclosporine in combination with punctal occlusion may produce the greatest overall improvements in dry eye symptoms 3.
- Cyclosporine may increase the number of conjunctival goblet cells, which could potentially lead to improved tear film stability 6.
- The evidence for the effectiveness of cyclosporine in treating dry eye is inconsistent, and more studies are needed to fully understand its effects 6.
Treatment Options
- Topical cyclosporine 0.05% ophthalmic emulsion (RESTASIS) is an FDA-approved treatment for dry eye 5, 6.
- Other concentrations of cyclosporine, such as 0.09% (Cequa), are also available for the treatment of dry eye 6.
- Cyclosporine can be used in combination with artificial tears or punctal occlusion for the treatment of dry eye 3, 6.