New Dry Eye Therapy Launched

A new dry eye prescription therapy is now available from Allergan, Inc. The company received approval earlier this year from the U.S. Food & Drug Administration (FDA) for RESTASIS, a prescription medication for patients who don’t produce sufficient tears due to eye inflammation associated with chronic dry eye disease (CDED), also known as keratoconjunctivitis.

CDED is a painful and irritating condition involving abnormalities and deficiencies in the tear film. Moderate-to-severe dry eye can lead to inflammation and may result in serious damage to the eye surface. The incidence of CDED increases markedly with age and after menopause in women and in people with systemic diseases such as Sjögren's syndrome, rheumatoid arthritis, lupus and diabetes. It is estimated that over one-million Americans suffer from chronic dry eye disease.

In pivotal Phase III studies, RESTASIS demonstrated significant increases in Schirmer wetting over six months. The Schirmer test measures the amount of tears produced in the eye. Increased tear production was not demonstrated in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Tears are secreted by the lacrimal and accessory glands and perform vital functions in the eye such as lubrication of the eyelids and surface of the eye, defense against bacteria, and flushing away foreign particles.

"The announcement that the FDA has approved Allergan’s RESTASIS is a landmark for patients, the company and the FDA,” said Michael A. Lemp, MD, member of the SSF Board of Directors. "This is the first therapeutic product, i.e., one that treats the disease tissue rather than treating symptoms, approved by the FDA. It represents the culmination of many years of research by Allergan and will provide patients with a treatment directed to controlling inflammation and restoring tear producing cells to their more natural state."

The most common adverse event following the use of RESTASIS was ocular burning (17%). Other events reported in 1% to 5% of patients included conjunctival hyperemia (red eye), discharge, epiphora (excessive tearing), eye pain, foreign body sensation, pruritus (itching), stinging, and visual disturbance (most often blurring).

RESTASIS hit the market in April 2003. A copy of the RESTASIS full prescribing information is available at www.restasis.com.

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