Allergan's RESTASIS Approved by the FDA; The First And Only Therapeutic Treatment To Increase Tear Production In Patients With Chronic Dry Eye Due To Ocular Inflammation.

Business Editors & Health/Medical Writers

IRVINE, Calif.--(BUSINESS WIRE)--Dec. 24, 2002

Allergan, Inc. (NYSE:AGN) today announced it has received approval from the United States Food & Drug Administration (FDA) for RESTASIS(TM) (cyclosporine ophthalmic emulsion, 0.05%), the first and only therapy for patients with keratoconjunctivitis sicca (chronic dry eye disease-CDED) whose tear production is presumed to be suppressed due to ocular inflammation. 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.

Dry eye disease, also known as keratoconjunctivitis sicca (KCS), is a painful and irritating condition involving abnormalities and deficiencies in the tear film initiated by a variety of causes. Moderate-to-severe dry eye can be associated with or can lead to inflammation and may result in serious damage to the ocular surface. The incidence increases markedly with age and after menopause in women and in people with systemic diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus and diabetes. In dry eye disease, RESTASIS(TM) is thought to act as a partial immunomodulator with anti-inflammatory effects, however, the exact mechanism of action is not known.

Approximately 60 million people worldwide use artificial tears. It is estimated that over one million suffer from chronic dry eye disease in the United States. Given the large number of individuals suffering from ocular surface disease, it is believed that the therapeutic segment of the chronic dry eye market could grow to be as large as $300-$500 million over the next three to five years.

"Approval for RESTASIS(TM) is great news for patients with tear production deficiencies associated with dry eye disease. This is a culmination of Allergan's research and development team's pioneering work in the field of ocular surface disease," said Lester J. Kaplan, Ph.D., Allergan's President of Research & Development. "We have been the scientific and marketing leader in this area and are very excited about the ability to offer the first therapeutic option for treatment."

In pivotal Phase III studies, RESTASIS(TM) demonstrated statistically significant and clinically relevant increases in Schirmer wetting versus vehicle at 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.

RESTASIS(TM) is contraindicated in patients with active ocular infection and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. RESTASIS(TM) has not been studied in patients with a history of herpes keratitis. The most common adverse event following the use of RESTASIS(TM) 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).

Allergan estimates that RESTASIS(TM) will be launched in the second quarter of 2003 and given the anticipated launch costs and royalties on the product, the profit impact in 2003 is expected to be modest. The company reiterates its expectations of mid-to-high teens growth in net sales and 22% to 25% earning per share growth for 2003. Allergan will provide 2003 sales estimates for RESTASIS(TM) and other key products in its year-end press release at the end of January 2003.

A copy of the RESTASIS(TM) full prescribing information is available at www.Restasis.com.

Forward-Looking Statements

Any of the above statements that refer to Allergan's estimated or anticipated future results and events, including statements regarding the intent, belief or expectations of Allergan and its officers, statements relating to earnings and revenue projections, statements regarding RESTASIS(TM), the timing of its launch, its anticipated therapeutic and commercial performance, and the potential size of the therapeutic dry eye market are forward-looking and reflect the company's current analysis of existing trends and information only. Actual results may differ from current expectations based on a number of factors affecting the company's businesses, including the timing and uncertainty of the results of both research and regulatory processes, and including the research, development, regulatory approval, introduction and consumer acceptance of new products, the challenges inherent in new product marketing such as the unpredictability of market acceptance for a new pharmaceutical product or approved indications, potential difficulties in manufacturing a new product formulation, and difficulties associated with predicting the size and growth potential of a new therapeutic market. These forward-looking statements represent the company's judgement only as of the date of this press release. Actual results could differ materially from those projected in this release. Therefore, the reader is cautioned not to rely on these forward-looking statements. The company disclaims, however, any intent or obligation to update these forward-looking statements. Additional information concerning these factors can be found in press releases as well as in Allergan's public periodic filings with the Securities and Exchange Commission, including Allergan's 2001 Form 10-K and its Form 10-Q for the quarter ended September 27, 2002.

Copies of Allergan press releases and additional information about Allergan are available on the World Wide Web at www.allergan.com, or you can contact the Allergan Investor Relations Department at 714/246-4636.

About Allergan, Inc.

Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator and skin care markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives.