IKERVIS

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IKERVIS

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of IKERVIS

IKERVIS (ciclosporin 0.1%) is a specialized, prescription-only eye drop emulsion used to treat severe keratitis (persistent inflammation of the cornea) in adult patients with dry eye disease (DED). It is typically initiated by an ophthalmologist when primary treatments, such as tear substitutes, have failed to adequately improve the condition. IKERVIS is designed to address the underlying chronic inflammation that drives the damage to the ocular surface.


Quick Facts

Property Description
Active Ingredient Ciclosporin
Form Eye drop emulsion (0.1% strength)
Pharmacological Class Topical Immunomodulator / Calcineurin Inhibitor
Common Use Severe keratitis in adult dry eye disease (DED)
Status Prescription Only (Rx)

IKERVIS functions as a topical immunomodulator. Its active ingredient, ciclosporin, works by suppressing the activity of immune cells, specifically T-lymphocytes, on the eye's surface, thereby blocking the inflammatory cycle. This mechanism allows the cornea to heal and reduces the severity of the keratitis. The formulation utilizes a unique cationic nanoemulsion technology, which is designed to enhance drug retention on the eye, supporting its convenient, once-daily application before bedtime.

This specific formulation of ciclosporin has been clinically recognized for its efficacy in the long-term management of chronic dry eye inflammation and the associated management of the condition.

The medicine is administered as one drop once daily. Because IKERVIS works by modulating the body's inflammatory response, the full therapeutic effect develops gradually over time, and continued use requires regular monitoring by a qualified eye care professional.

What side effects are possible with IKERVIS?

Possible Side Effects and Safety Information

The safety profile for IKERVIS is defined by official regulatory classifications of adverse reactions, which are primarily local and ocular. The most frequent reactions are generally expected to be transitory and mild to moderate.

Officially Documented Adverse Reactions

The frequency of side effects is categorized according to regulatory standards (e.g., EMA/ICH frequency bands):

Frequency Category Rate Examples of Documented Reactions
Very Common 1/10 Eye pain, Eye irritation
Common 1/100 to < 1/10 Ocular hyperaemia (eye redness), Increased lacrimation, Vision blurred, Eyelid erythema
Uncommon 1/1,000 to < 1/100 Conjunctivitis, Non-infectious Keratitis, Blepharitis, Headache

Most reported events fall under the System-Organ Class of Eye Disorders. Uncommon reactions include specific infections, such as Bacterial keratitis and Herpes zoster ophthalmicus, as documented in regulatory labeling.

Safety Considerations and Restrictions

Due to the medicine's nature as an immunomodulator, regulatory documents note that long-term use may affect host defenses against local infections and malignancies, and regular eye examination is recommended when the product is used for years. The label mandates specific restrictions and safety notes:

  • Contraindications: Use is restricted in patients with an active or suspected ocular or peri-ocular infection.
  • Contact Lenses: Lenses must be removed prior to application (due to the excipient cetalkonium chloride) and may be reinserted upon waking.
  • Vulnerable Populations: IKERVIS is not recommended for use in children and adolescents below 18 years of age. It is also not recommended during pregnancy, and women of childbearing potential are required to use effective contraception.
  • Driving Ability: The medicine may induce temporary blurred vision that can affect the ability to drive or use machinery immediately after application.

These classifications and restrictions strictly define the medicine's safety profile as established by government health authorities.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents for IKERVIS (ciclosporin 0.1% eye drop emulsion) classify the likelihood of an overdose following topical ocular administration as not likely to occur. Due to the formulation and the low systemic concentrations of ciclosporin achieved after application to the eye surface, the possibility of systemic intoxication is remote. Specific symptoms or clinical signs related to an ocular overdose are not documented in the official prescribing information.

Officially Mandated Actions

The required actions in an overdose scenario are dependent on the exposure route, as strictly defined by regulatory authorities.

Exposure Scenario Official Mandate
Accidental Oral Ingestion Seek immediate medical attention or contact a poison information center. This action is mandated by regulators as the primary emergency situation, even if the person experiences no immediate symptoms.
Excessive Topical Use If too much of the medication is placed in the eye, the required action is to immediately rinse the affected eye(s) with water.
General Overdose Management If any form of overdose occurs, the general regulatory guidance states that the treatment should be symptomatic and supportive.

There is no specific antidote for ciclosporin ophthalmic emulsion documented in the official regulatory prescribing information. The official regulatory focus remains on the specific instruction to seek immediate medical help solely in the event of accidental swallowing of the eye drops.

Therapeutic Uses of IKERVIS

What IKERVIS Treats: Main Uses and Benefits

IKERVIS is commonly used to help manage severe keratitis, an inflammatory condition of the cornea, in adult patients with Dry Eye Disease (DED) when initial tear substitute treatment has proven inadequate. The medication is relevant in clinical contexts involving the symptom burden associated with chronic ocular surface irritation.

IKERVIS is applied in situations where patients experience noticeable damage to the corneal surface. The medication is used for managing conditions characterized by periods of heightened symptoms, specifically severe keratitis and chronic ocular surface inflammation.

Sustained Relief and Intervention

IKERVIS is relevant for managing symptom clusters that create noticeable physiological strain, such as chronic pain, intense burning, stinging, and the sensation of a foreign body in the eye. It offers supportive relief that helps patients cope more steadily with difficult episodes, thereby helping to improve day-to-day comfort during symptomatic periods. The medication is commonly used across conditions presenting with heightened symptoms, applied in scenarios where additional management of discomfort is required after initial symptomatic support. It assists with maintaining functional stability in the presence of severe disease, providing supportive relief when symptoms interfere with routine activities.


Quick Fact: Relief for Refractory Symptoms
Primary Use: Severe corneal inflammation (keratitis) in adult DED.
Symptom Focus: Chronic pain, burning, irritation, and foreign body sensation.
Clinical Context: Used after failure of lubrication/tear substitutes.
Main Benefit: Supports functional stability and helps ease the overall symptom load.

Eligibility and Restrictions for Use

Who Can and Cannot Use IKERVIS?

Official eligibility for IKERVIS is strictly defined by regulatory labeling based on age restrictions and absolute contraindications.

Approved Population and Age Eligibility

IKERVIS is approved for use only in adult patients (18 years of age and older) for severe keratitis in dry eye disease that has not improved with tear substitutes. The medicine’s use in children and adolescents below 18 years is not established for this indication. Older adults have been studied and require no dose adjustment.


Absolute Contraindications

Use of IKERVIS is strictly contraindicated if a patient has any of the following conditions:

  • Hypersensitivity to the active substance (ciclosporin) or to any excipient.
  • Ocular or peri-ocular malignancies or premalignant conditions.
  • An active or suspected ocular or peri-ocular infection.

Conditional and Restricted Use

Population/Condition Eligibility Status (Regulatory Wording)
Pregnancy Not recommended (unless benefit outweighs risk).
Childbearing Potential Not recommended without effective contraception.
Ocular Herpes History Use with caution.
Contact Lens Wearers Use not recommended; lenses must be removed before instillation.
Renal/Hepatic Impairment No special considerations are needed due to minimal systemic absorption.

What should I know about interactions with other medicines?

The documented interaction profile for IKERVIS (ciclosporin 0.1% eye drop emulsion) is characterized by its topical route of administration, which results in negligible systemic absorption of the active ingredient. Official regulatory sources explicitly state that no systemic pharmacokinetic interaction studies have been conducted. As a result, there are no established regulatory statements concerning interactions with oral systemic medicines, food, alcohol, or herbal products.

Ophthalmic Product Administration Requirements

Interactions are concentrated on the local application procedure. A procedural requirement exists when IKERVIS is used alongside any other topical ophthalmic medicinal product. To ensure drug retention, all other eye drops must be administered with a mandatory separation of at least 15 minutes apart from IKERVIS. IKERVIS is formally required to be the final medicine administered within any such co-administration regimen.

Pharmacodynamic Considerations

A specific pharmacodynamic interaction is documented regarding the co-administration of IKERVIS with topical corticosteroids in eye drop form. Regulatory documents note that this combination could potentiate the effects of ciclosporin on the immune system, an additive immunosuppressive effect that requires formal caution.

Given the minimal systemic exposure, the official label confirms that no special precautions regarding interaction risk are necessary for specific patient populations, including those with renal or hepatic impairment.

Mechanism of Action

The mechanism of action for IKERVIS is centered on intracellular immunomodulation, specifically targeting the core signaling pathways within T-lymphocytes on the ocular surface.

Molecular Inhibition of Calcineurin

IKERVIS exerts its effect by acting as an indirect inhibitor of the enzyme Calcineurin within T-lymphocytes. The active component, ciclosporin, binds to the protein Cyclophilin A to form a complex that blocks Calcineurin's function. This interaction is a critical first step in modifying the cell's signaling dynamics, serving as a specific biological target for the drug's pharmacodynamic consequences.

Suppression of Pro-Inflammatory Signaling

The inhibition of Calcineurin prevents the activation and nuclear translocation of the transcription factor NF-AT, which, in turn, suppresses the gene expression of major pro-inflammatory cytokines (e.g., IL-2). This mechanistic cascade directly limits the cell's ability to proliferate and release inflammatory mediators. This physiological change contributes to the modulation of immune responses within the local environment.

Interruption of the Chronic Inflammatory Cascade

The sustained suppression of T-cell activity and cytokine production effectively interrupts the self-perpetuating inflammatory cascade mediated by these immune cells. This mechanism leads to the progressive modulation of the physiological environment on the ocular surface, contributing to a regulated state within the targeted pathways. The resulting physiological effect is time-dependent, reflecting the turnover needed to fully modulate the immune-driven inflammatory response.

Dosage and Administration Information

How IKERVIS is Used: Official Dosing and Administration

IKERVIS (ciclosporin 0.1% eye drop emulsion) is administered according to a specific, standardized protocol for the long-term management of severe keratitis in adult dry eye disease. Treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.


Administration and Dosage Regimen

Feature Official Instruction
Route of Administration Ocular use (applied directly to the eye).
Dose and Frequency One drop per affected eye, once daily.
Timing Instillation is specifically advised to occur at bedtime.
Missed Dose If a dose is missed, treatment should continue the next day; a double dose must not be used to compensate.

Procedural Instructions and Constraints

The emulsion, which comes in a single-dose container, must be gently shaken before use. Following instillation, patients are instructed to perform nasolacrimal occlusion and close the eyelids for 2 minutes to help reduce the drug’s systemic absorption and increase its local effect on the ocular surface.

When using IKERVIS alongside other topical ophthalmic medicines, there must be an interval of at least 15 minutes between applications, and IKERVIS should always be instilled last. Furthermore, contact lenses must be removed before applying the drops at night and may only be reinserted upon waking the following morning.

Treatment is intended to be long-term, but the response to therapy must be reassessed by a specialist at least every 6 months.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Evaluating the Efficacy and Safety Profile

Studies have examined the role of Ikervis (ciclosporin) in the management of the target condition, which is severe keratitis in adult patients with dry eye disease not improving despite treatment with tear substitutes. Research evaluated whether the drug influenced the duration of symptom improvement.

Key Findings on Symptom Evaluation

  • The results reported by clinical trials showed that the drug was explored as a possible approach for the study of short-term symptoms.
  • Studies assessed the drug's effect on the frequency and severity of episodes, focusing primarily on corneal staining as a measure of disease severity.
  • Research evaluated the onset and magnitude of improvement following administration of the medication. Studies compared the drug's influence against that of a placebo.

Exploring Treatment Approaches

Research evaluated the influence of the treatment on outcomes in the studied population. This area of research focused on whether the use of the drug altered the overall response related to ocular surface health.

  • Dosing and Administration: Studies explored various administration conditions in relation to the treatment's effect. The research examined the use of the solution once daily and its reported effects on the study participants.
  • Patient Response Variability: Findings from the research were mixed, with some studies reporting a pronounced effect in certain subgroups, while others showed a less noticeable change in symptoms. It is not yet clear whether the treatment has a uniform effect across all individuals. The research reported on the tolerability profile of the drug in study participants, with eye irritation and pain being among the most common adverse events observed in trials.

Key Studies & References IKERVIS 1 mg/mL eye drops, emulsion - Summary of Product Characteristics (SmPC)

Frequently Asked Questions (FAQ)

Common questions about IKERVIS (FAQ)


Q: How quickly does IKERVIS typically start working to relieve symptoms?

A: IKERVIS is a type of medicine called an immunomodulator, which means it works by gradually modifying the underlying inflammatory response. According to official product information, the full therapeutic effect develops over time. Clinical studies generally evaluated the condition’s response over a period of six months or more.


Q: Can I use IKERVIS with other over-the-counter artificial tears?

A: Yes, IKERVIS can be used alongside other topical ophthalmic medicines, which includes artificial tears. Regulatory documents require that all other eye drops be administered at least 15 minutes before applying IKERVIS. Official guidance requires that IKERVIS be the final medicine instilled in any co-administration regimen.


Q: Does IKERVIS interact with common medications like blood pressure pills or NSAIDs?

A: Official product information notes that because IKERVIS is applied topically to the eye, only a minimal amount of the active ingredient, cyclosporine, is absorbed into the bloodstream. Due to this minimal systemic exposure, regulatory documents indicate no systemic interactions have been established or formally studied with oral medications.


Q: Do I need to wait a certain time before using other eye drops after IKERVIS?

A: When co-administering multiple eye drops, official guidance specifies that IKERVIS must be the final drop instilled in any co-administration regimen. A minimum of 15 minutes is still required to separate all applications.


Q: Is IKERVIS supposed to reduce the redness in my eyes?

A: IKERVIS is intended to reduce the underlying inflammation associated with severe dry eye disease. While this may lead to an improvement in symptoms, it is noted that ocular hyperaemia (eye redness) is also a common, temporary side effect that can occur after instillation, according to official safety information.


Q: What does the research say about stopping IKERVIS and the return of symptoms?

A: IKERVIS is indicated for the long-term management of chronic inflammation. Official documents suggest that if treatment is discontinued, the specific corneal inflammation may no longer be controlled. If discontinuing IKERVIS, it is important to follow the guidance of the prescribing specialist regarding monitoring and follow-up.


Q: What does IKERVIS feel like when you put it in?

A: It is common to experience some local sensations when using IKERVIS. According to regulatory documentation, eye pain and eye irritation are very common side effects reported during the instillation process. These sensations are commonly reported as transitory and typically lessen shortly after application.


Q: Why does IKERVIS come in single-use vials?

A: IKERVIS is provided in single-dose containers as a sterile, preservative-free emulsion. This packaging helps maintain the product's sterility, as each vial is designed for a single use only. Any remaining medicine must be discarded immediately after use.


Q: How long can a single vial of IKERVIS be kept after opening?

A: The single-dose container of IKERVIS is intended for one application only. For safety and sterility, all regulatory instructions state that any unused emulsion remaining in the vial must be discarded immediately after you have used the drops, and it should not be saved or reused for a later application.


Q: What happens if I accidentally put too many IKERVIS drops in my eye?

A: According to official safety information, a topical overdose is not likely to occur after using the drops on the eye. If you accidentally use more than one drop, it is generally advised to rinse the eye with water. If there is any concern about overdose, consulting a healthcare professional is recommended.


Q: Are there any cosmetic side effects like changes in eyelash growth?

A: Official safety documents include a comprehensive list of all observed adverse events in clinical trials. The list of adverse events reported in official product information does not include changes in eyelash growth as a side effect for IKERVIS.


Q: How does the active ingredient in IKERVIS specifically target dry eye?

A: The active ingredient, ciclosporin, is a topical immunomodulator. It works by suppressing the activity of immune cells called T-lymphocytes on the eye's surface. This suppression is part of the drug’s intended action to manage the chronic inflammation associated with severe keratitis in dry eye disease.


Q: What research or clinical trials support the use of IKERVIS?

A: The benefits and safety of IKERVIS were assessed through several clinical trials reviewed by regulatory bodies. The main study used to support its approval involved 246 patients with severe dry eye disease, where it was compared with the vehicle (the drops without the active medicine) over a six-month period.


Q: Does IKERVIS have any known interactions with alcohol or caffeine?

A: Due to the minimal systemic absorption of IKERVIS, no formal studies were conducted on systemic interactions with food, alcohol, or herbal products. Therefore, there are no established regulatory statements concerning these specific interactions.


Q: Is it normal for my vision to be slightly cloudy right after putting in the drops?

A: Blurred vision is listed as a Common side effect in regulatory documents that occurs immediately after the eye drops are used. This effect is short-lasting, and you should wait until your vision clears before engaging in activities like driving or operating machinery.


Q: Do I need to tell my dentist I am using IKERVIS?

A: General guidance from regulatory sources suggests informing any healthcare professional who treats you, including doctors, dentists, or pharmacists, about all medicines you are taking. This ensures they have full visibility into your current medications.


Q: Is the vehicle/carrier solution in IKERVIS different from other eye drops?

A: Yes, IKERVIS utilizes a specific formulation known as a cationic nanoemulsion. This advanced technology is designed to enhance the retention of the medication on the surface of the eye, which helps support its convenient, once-daily application.

How should IKERVIS be stored and disposed of?

How to Store and Dispose of IKERVIS

IKERVIS storage and disposal are governed by official requirements to maintain the integrity of the emulsion.

Storage Conditions

Requirement Specification
Temperature Store the unopened product below 25°C (77°F). Do not freeze.
Protection Store in the original aluminium pouch to protect the single-dose containers from light and evaporation.
Safety Keep IKERVIS out of the sight and reach of children.

Handling and Disposal

The product is provided in single-dose containers for single use only. Once an individual container is opened, any remaining emulsion must be discarded immediately after use and must not be saved. All unused or expired medicinal product and waste material must be disposed of in accordance with local requirements for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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