Eysuvis

Short-Term Relief of Dry Eye

Eysuvis is used to treat the signs and symptoms of dry eye disease. It is specifically designed for short-term use to manage flares, which are episodes where symptoms like pain, redness, and irritation become more severe.

Common situations where this medication might be prescribed include:

• Rapid relief of inflammation during a dry eye flare.
• Reducing eye surface irritation caused by environmental triggers.
• Managing discomfort when other dry eye treatments are not sufficient for sudden symptom spikes.

Because it is a corticosteroid, it is generally used for a limited time, typically up to two weeks, to minimize the risk of side effects associated with long-term steroid use in the eyes.

How Eysuvis Works

Eysuvis contains loteprednol etabonate, a type of medication known as a corticosteroid. It is specifically used for the short-term treatment of dry eye disease symptoms by targeting the underlying inflammation that occurs on the surface of the eye.

When the eyes are chronically dry, the surface can become irritated and inflamed. This inflammation leads to common symptoms such as redness, burning, and itching. Eysuvis works by entering the cells on the eye's surface and blocking the production of certain chemicals that trigger the inflammatory response.

The medication helps manage symptoms through the following actions:

• Inhibiting the release of substances that cause swelling and redness.
• Reducing the activity of inflammatory mediators in the eye tissue.
• Soothing the ocular surface to provide relief during dry eye flares.

Eysuvis is formulated with specific technology designed to help the active ingredient penetrate the tear film and reach the surface of the eye more effectively. Additionally, loteprednol is often described as a soft steroid because it is designed to be broken down quickly by the body after it performs its function. This rapid metabolism is intended to help lower the risk of certain side effects, such as increased pressure inside the eye, which can be more common with other types of steroid eye drops.

Common Side Effects

The most common side effect reported with Eysuvis is pain or stinging at the site of application. Other frequent side effects may include:

• Blurred vision
• A feeling that something is in the eye (foreign body sensation)
• Headache
• Eye discharge or itching

Serious Side Effects

While less common, Eysuvis can cause serious side effects, especially if used for longer than the recommended duration. These may include:

• Increased eye pressure: Prolonged use of corticosteroid eye drops can raise the pressure inside the eye (intraocular pressure), which may lead to glaucoma or damage to the optic nerve.
• Cataracts: Long-term use of steroids in the eye may contribute to the formation of cataracts.
• Delayed healing: This medication may slow down the healing process after eye surgery or injury.
• Secondary infections: Steroid use can weaken the eye's ability to fight infections, potentially leading to fungal, viral, or bacterial eye issues.

If you experience sudden vision changes, severe eye pain, or signs of a new eye infection, contact a healthcare professional immediately. It is important to have your eye pressure monitored if you use this medication for more than 10 days.

Infection Risks

Eysuvis should not be used by individuals with most viral diseases of the cornea and conjunctiva, including herpes simplex keratitis, vaccinia, and varicella. It is also contraindicated for those with mycobacterial infections of the eye or fungal diseases of ocular structures. Using corticosteroids can mask or worsen existing infections and may increase the risk of secondary infections by suppressing the body's immune response.

Intraocular Pressure

Prolonged use of corticosteroid eye drops may lead to increased intraocular pressure (IOP), which can cause glaucoma and damage to the optic nerve. If this medication is used for 10 days or longer, a healthcare professional should monitor the pressure inside the eye.

Cataract Formation

Long-term use of topical corticosteroids is associated with the development of posterior subcapsular cataracts.

Delayed Healing

The use of steroids after cataract surgery may slow the healing process. In conditions that cause thinning of the cornea or sclera, the use of topical steroids has been known to cause perforation of the eye.

Contact Lens Use

The preservative in Eysuvis may be absorbed by soft contact lenses. Contact lenses should be removed before administering the drops and should not be reinserted during the treatment period for dry eye disease flare-ups.

Pregnancy

There are no adequate or well-controlled studies regarding the use of Eysuvis in pregnant women. In animal studies, high oral doses of loteprednol etabonate (the active ingredient in Eysuvis) were shown to cause harm to the developing fetus. However, when used as an eye drop, very little of the medication is absorbed into the bloodstream compared to oral administration.

Because of the lack of human data, Eysuvis should be used during pregnancy only if a healthcare provider determines that the potential benefit to the mother justifies the potential risk to the fetus.

Breastfeeding

It is not known whether Eysuvis passes into human breast milk after being applied to the eye. While corticosteroids taken by mouth or injection can pass into breast milk and potentially affect a nursing infant's growth or hormone production, topical eye drops result in much lower levels of the drug in the body.

Caution is recommended when using this medication while breastfeeding. Individuals should discuss the potential risks and benefits with their healthcare provider to determine the best course of action for their specific situation.

Dosage Forms

Eysuvis is available as a sterile ophthalmic suspension. This is a liquid medication intended for topical application to the eye.

Available Strengths

This medication is provided in a single concentration:

• 0.25% loteprednol etabonate

The suspension is supplied in a plastic dropper bottle designed for ocular use.

FDA Approval Status

The U.S. Food and Drug Administration (FDA) approved Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% in October 2020. It was the first corticosteroid specifically approved for the short-term treatment of dry eye disease.

Approved Indications

Eysuvis is indicated for the short-term treatment of the signs and symptoms of dry eye disease. The clinical trials supported its use for up to two weeks of continuous treatment.

Regulatory Considerations

• Drug Class: Eysuvis is classified as a corticosteroid.
• Boxed Warnings: This medication does not have any FDA boxed warnings.
• REMS: There is no Risk Evaluation and Mitigation Strategy (REMS) required for this drug.

Regulatory labeling includes warnings common to ophthalmic corticosteroids, such as the risk of increased intraocular pressure, delayed healing, and the potential for secondary infections or cataracts with prolonged use. Because of these risks, the FDA-approved labeling specifies that the medication is intended for short-term use.

Brand-Name Status

Eysuvis is currently available only as a brand-name medication. There is no generic version of this specific 0.25% loteprednol etabonate suspension. Brand-name drugs generally have a higher retail price than generic alternatives.

Factors Affecting Price

Several factors influence the out-of-pocket cost for Eysuvis:

• Insurance Coverage: Health insurance plans vary in how they cover brand-name ophthalmic drops. The cost will depend on the plan's formulary, deductible, and copayment or coinsurance requirements.
• Pharmacy Choice: Prices may differ between local retail pharmacies and mail-order pharmacy services.
• Medicare: Coverage for Eysuvis under Medicare Part D or Advantage plans varies by specific provider and plan tier.

Financial Assistance

The manufacturer may offer savings cards or patient assistance programs to help reduce costs for eligible individuals. These programs are often intended for patients with commercial insurance or those who meet specific income requirements. Patients are encouraged to check with the manufacturer or their pharmacist for current availability and eligibility criteria.