Corneal Consultants of Colorado, P.C.: Restasis Ophtalmic Emulsion


For Chronic Dry Eye: Restasis® Ophtalmic Emulsion from Allergan
Chronic Dry Eye can be caused by a functional problem in the tear-producing gland of the eye. This can result in a declining quantity of tears. High risk factors for this condition include those individuals with health factors such as hormonal changes associated with aging and menopause, autoimmune diseases such as arthritis, lupus and Sjögren's syndrome. Medical conditions such as diabetes also can contribute to its onset. Environmental, occupational and lifestyle factors, such as allergies, smoke, dry air, dust, the wearing of contact lenses for extended periods of time or prolonged computer use can aggravate Chronic Dry Eye, but they are not the cause. A cause of Chronic Dry Eye can be a dysfunction of the tear-producing gland which can result in reduced production of tears.

RESTASIS OPHTALMIC EMULSION®

WHAT IS CHRONIC DRY EYE?

Chronic Dry Eye, sometimes called Dry Eye Disease, is known by the scientific name keratoconjunctivitis sicca. It is a common condition that can result in localized inflammation on both the eye surface as well as the tear-producing glands. Over time, inflammation can decrease the eye's ability to produce tears that protect the surface of the eye and keep it moist and lubricated. This, in turn, can lead to damage to the eye's surface. If left untreated, severe forms of the condition can lead to more serious problems, including increased risk of infection and possibly vision impairment.

Chronic Dry Eye may be caused by a decreased ability to produce tears, which are needed

to protect the surface of the eye.

Chronic Dry Eye affects millions of Americans

Up to 25% of all visits to Eye Care Professionals are due to dry eye, making it one of the

most common complaints seen by Eye Care Professionals1

How is Chronic Dry Eye Diagnosed?

Patients may present with eyes that feel dry, or they may state that they areusing artificial tears frequently throughout the day. Eye Care Professionals may want to perform one or more of these tests:

Schirmer's Test is performed by placing filter paper inside the lower lid of the eye. After a

few minutes, the paper is removed and tested for moisture content

Tear break-up time (the amount of time a tear maintains a coat over the eye) can be

measured with or without fluorescein stain

Surface eye staining with either rose Bengal, Lissamine green, or fluorescein dyes will stain

the damaged area of the ocular surface

Only an Eye Care Professional can diagnose this condition

WHAT IS RESTASIS®?

RESTASIS® Ophtalmic Emulsion is the only eye drop proven to increase tear production in

patients with Chronic Dry Eye. Increased tear production was not seen in patients taking

topical anti-inflammatory drugs or using tear duct plugs

HOW IS RESTASIS® DIFFERENT FROM ARTIFICIAL TEARS?

Artificial tears provide temporary relief

In patients with Chronic Dry Eyes, RESTASIS® Ophtalmic Emulsion works by increasing the

production of your eyes' own tears. Artificial tears do not increase tear production

HOW FREQUENTLY DOES A PATIENT APPLY RESTASIS®?

RESTASIS® Ophtalmic Emulsion only needs to be applied twice a day-- one drop in each eye

approximately 12 hours apart

HOW LONG WILL A PATIENT HAVE TO USE RESTASIS®?

Patients may benefit from increased tear production as long as they're on RESTASIS®

Ophtalmic Emulsion therapy

IS RESTASIS® WELL TOLERATED?

RESTASIS® Ophtalmic Emulsion has been studied in clinical trials and has shown no

systemic absorption or interaction with other drugs

The most common side effect experienced by some patients is a burning sensation

(approximately 1 in 5) when first applying RESTASIS® Ophtalmic Emulsion

HOW SHOULD PATIENTS WHO WEAR CONTACT LENSES USE RESTASIS®?

People with decreased tear production typically should not wear contact lenses

RESTASIS® Ophtalmic Emulsion should not be administered while wearing contacts

Patients must remove contact lenses 15 minutes before applying RESTASIS®

ARE THERE ANY REASONS WHY PATIENTS SHOULDN'T USE RESTASIS®?

RESTASIS® Ophtalmic Emulsion should not be used in patients with active infections of the

eye

RESTASIS® has not been studied in patients with a history of active herpes viral infections

of the eye

RESTASIS® Ophtalmic Emulsion is contraindicated in patients with known or suspected

allergies to any of the ingredients in the formulation

IS RESTASIS® COVERED BY MANAGED CARE PLANS?

Nearly 90% 0f formularies recognize and cover RESTASIS® Ophtalmic Emulsion

RESTASIS® Ophtalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking anti-inflammatory drugs or using punctal plugs.

RESTASIS® is contraindicated in patients with active ocular infections and has not been studied in patients with a history of herpes keratitis. The most common adverse event was ocular burning (upon instillaton) --17%.

Other events reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).

References: 1. Stevenson D, Tauber J, Reis BL. The Cyclosporin A Phase 2 Study Group, Efficacy and safety of cyclospori, A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial. Ophthalmology. 2000; 107: 967-974. 2. NDC, Data on file, January 2003-January 2004.

© 2004 Allergan, Inc., Irvine, CA 92612

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