Two issues are important for practitioners to note as they begin to prescribe Restasis. First, the proposed mechanism of action is important, and the recommendations for use are specific. Second, in addition to providing the required information about dosing, mechanism of action and potential side effects, the product package insert also includes contact lens management advice.
No Easy Answers
While the exact action mechanism is unknown, it is thought that Restasis decreases the inflammatory reaction in dry eye disease by inhibiting T-cells (partial immunomodulation) and by preventing pro-inflammatory cytokine release (anti-inflammatory effect). This dampening of the inflammatory process takes place on the ocular surface as well as at the lacrimal gland, allowing tear function and production to return to normal levels.
In Phase III FDA studies, Restasis demonstrated statistically significant increases in Schirmer wetting at six months-tear production increased. While the fine print is not specific, data indicates that Restasis may be the preferred treatment for patients with aqueous deficient dry eye, or those with reduced Schirmer scores.
This means you should perform a Schirmer test prior to prescribing this medication. If the Schirmer score is normal (and we could argue what constitutes normal), this medication may not induce the optimal response. Does that mean you should not use this medication with evaporative dry eye? There is no easy answer to this question. Clearly, as with all medications, there will be some cases where the medication does not produce the desired results. Your advice to the patient should take this into consideration.
Restasis and Contact Lenses
While the insert clearly says that Restasis should not be instilled with contact lenses on the eye, it also provides contact lens management advice-patients with decreased tear production typically should not wear contact lenses.
I believe pretty strongly in my ability to decide who should and who should not wear contact lenses. Fitting contact lenses is
challenging in patients with dry eye disease. It is true that decreased tear production can limit comfortable contact lens wearing time. However, it is possible that patients can achieve adequate contact lens wear without damage to the ocular surface or increased ocular infection risk.
Could using this anti-inflammatory medication pre- and postcontact lens wear provide a comfortable environment for a contact lens? Sure. With proper patient and doctor motivation, appropriate expectations and adequate follow-up, the addition of Restasis could be “what the doctor ordered.”
This does not mean that Restasis should be prescribed with wild abandon, as often occurs with a new medication. Restasis is a new weapon in our existing armamentarium. Decide carefully if it is right for the patient. Consult insurance formulae, and discuss expectations. Most of all, prescribe responsibly for your patients.The Restasis website (www. restasis.com) reports the drug is available as of early April 2003. Restasis will be sold as a sealed tray-package of 32 single-use vials. Each 0.9ml vial contains 0.4m1 of the medication, and the recommended dosing is two times per day (12 hours apart). Restasis can be used with artificial tears, allowing a 15-ininute interval between products. CLS
Dr. Nichols is assistant professor of clinical optometry at The Ohio State University College of Optometry in the area of dry eye research.
Contributor: Kelly Kinney Nichols