Introduction

There are many causes of dry eyes, and this very uncomfortable condition can cause long-term damage to the surface of the eye. Because the tears contain not just salt water, but several other ingredients that have been shown to have a positive effect on reducing the growth of bacteria, a lack of adequate tears is a real threat. The sooner this condition is treated, the better.

If there are indications that the tear film is inadequate, and especially if the patient suffers from inflammatory disease such as lupus or acne rosacea, or if the eyecare specialist suspects the decrease in quantity of the tears is due to underlying inflammation, there is a treatment available called Restasis. Many clinicians believe that inflammation is the underlying cause of most dry eye cases.

Restasis is not a lubricant or replacement eye drop, but a prescription medicine, 0.05% cyclosporine, which helps the eyes regain and recover the ability to produce more tears. In other words, it can lead to the eyes producing more of their own tears, a better solution in the long term than trying to replace them artificially. Inflammation can cause a decrease in the signals which tell the lacrimal glands to produce more tears, which leads to reduced tear quantity. By treating the inflammation, Restasis can help rebalance the amount of tears available in the eye.

Before Restasis was approved for the treatment of dry eyes, four clinical studies were done in over one thousand patients with moderate to severe dry eyes. Of those patients using Restasis (The control group was given only the eye drop, without the active ingredient of Restasis.) a significant increase in the production of tears was found after six months of use. The effect was present in about 15% of the patients treated.

Ocular lubricants and replacement tears certainly have their place in the treatment of dry eyes. For one thing, they can almost always give patients immediate relief of symptoms, but, unfortunately, their effects are only temporary, sometimes lasting only minutes, and patients must use them often for effectiveness. It can be difficult for the average person to keep using them during daily life. Restasis treats the tear deficiency by reducing the inflammation. It is the only therapeutic eye drop for dry eyes that is not an eye lubricant or replacement, but an anti-inflammatory drug.

With regular use over time, the eye should begin to manufacture more of its own tears, relieving symptoms. Patients should be aware, however, that relief will not be instant, but might not be noticeable for up to three to six months. Meanwhile, it is important to continue its daily use, as instructed by the eyecare specialist.

There are two factors which may interfere with successful use of Restasis: the first is the cost of the medication, and the second is its side effects.

Cost

Restasis is packaged in single-use vials, in packs of 30 or 60 vials. The manufacturer, Allergan, recommends that one drop should be used in each eye, twice a day, about 12 hours apart. Patients are instructed to open a new vial, insert one drop into each eye immediately after opening, and to discard any remaining fluid and the vial. Following these instructions, the patient will use two vials of Restasis a day, so one package of 60 vials will be a one-month supply.

Insurance coverage for Restasis varies by insurer, and patient co-pay amounts vary widely. Without insurance drug coverage, a package of 60 one-use vials, costs about $350.00. There are several programs that help patients get the medication at a lower cost, utilizing coupons and reduced pricing for qualifying persons. Most individuals who have drug coverage under their medical insurance will have co-pay amounts of $20 to $50 per month, but this does vary widely.

Once full effectiveness has been reached, some patients may be able to retain their increased production of tears, even if they discontinue the medication completely, while others must continue to use at least one drop per day. A majority of patients must continue to use the drug at full dosage of two drops per day, indefinitely.

Some clinicians feel comfortable instructing their patients to use one single-use vial each day, opening the new one in the evening, storing it in the closed package overnight and using the remaining medication the next morning. This will have the effect of cutting the cost of the drug in half, at once. Caution and care must be used, however, as the contents are not preserved and, once opened, can be contaminated, especially if the dropper tip touches the eye when it is used the first time. To decrease the chance of infection, clinicians also tell their patients to refrigerate the package, which also helps to alleviate some of its side effects. (See below.)

Side Effects

The most common side effect of Restasis is burning, followed by redness, foreign body sensation, eye pain, blurred vision and eye watering. Patients also have reported headache, sore throat and sinus problems.

Allergan recommends that Restasis be stored at room temperature, however, most patients find that refrigerating it helps reduce the burning and other effects listed above.

Punctal occlusion, a technique of pinching the corners of the eyes near the nose immediately after using the drops for about 30 seconds, is also helpful in reducing the burning sensation, as well as keeping the drop in the eye itself and not allowing it to drain immediately into the back of the throat or into the nasal passages.

Conclusions and Overview

Finding the right combination of dosage and minimizing of side effects is important for successful treatment with Restasis. It is, as yet, the only prescription medication used for the treatment of dry eyes, but it is important to understand that it will only be helpful to those whose symptoms are caused by underlying inflammation. For those patients, however, results are reported to be positive for long-term relief, and some clinicians do feel that most cases of dry eye do have an underlying inflammatory component as their cause.

Other methods can also help increase success with Restasis, such as concurrent treatment with other anti-inflammatory drops like Lotemax, especially early in the therapeutic cycle when immediate relief is being sought by all concerned parties. The prescribing information for Restasis recommends that other eye drops be used at least 15 minutes apart from Restasis so that one drop doesn’t wash the other away before it can take effect.

It is recommended that contact lenses be inserted at least 15 minutes after Restasis has been used.

One of the most helpful methods for dry eye treatment is the use of punctal plugs, which help keep the patient’s own tears in the eye longer; Allergan states that Restasis has not been shown as effective here, but this may only be due to a lack of testing in this population.

When used consistently, Restasis can be effective in the long-term successful treatment of patients with moderate to severe dry eyes; it should be considered as one of several effective ways to help these patients towards much better comfort and the protection of their own tears for their own eyes.