FDA Approves Lumigan 0.01% Ophthalmic Solution

Allergan, Inc. Receives FDA Approval for Lumigan 0.01% as First-Line Therapy Indicated for the Reduction of Elevated Intraocular Pressure in Glaucoma Patients

IRVINE, Calif.--(BUSINESS WIRE)--Aug 31, 2010 - Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Lumigan 0.01% is an optimized reformulation of Lumigan (bimatoprost ophthalmic solution) 0.03%.

"The approval of Lumigan 0.01% provides doctors with an efficacious, safe and well-tolerated IOP-lowering medication for glaucoma patients who are either starting treatment or are changing their medication regimen," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development, Chief Scientific Officer. "Lumigan 0.01% exemplifies Allergan's commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure."

Lumigan 0.01% is a once-daily prescription eye drop that provides effective and sustained IOP lowering. In a three-month study of patients with open-angle glaucoma or ocular hypertension with an average baseline of 23.5 mm Hg, Lumigan 0.01% lowered IOP up to 7 mm Hg from baseline, with only one-third the drug exposure of Lumigan 0.03%.1 The most common side effects of Lumigan 0.01% are hyperemia (red eyes), eyelash growth and ocular pruritis (itchy eyes).

"Once-a-day prostaglandins are becoming a therapy of choice based on their efficacy, systemic safety and ease of use," said L. Jay Katz, M.D., Director of the Glaucoma Service at Wills Eye Hospital and Professor of Ophthalmology at Jefferson Medical College. "Based on its efficacy and tolerability, Lumigan 0.01% should be considered early in the treatment continuum as an alternative to other prostaglandins or therapies."

Lumigan 0.01% will be available in the fourth quarter of 2010, and is the newest addition to Allergan's comprehensive glaucoma portfolio.

About Glaucoma

Glaucoma, a group of eye diseases characterized by damage to the optic nerve, is a leading cause of preventable blindness in the United States.2 It is estimated that 3 million Americans have glaucoma, but only half of those know they have it.3 The total number of glaucoma cases worldwide is estimated to be 65 million.3 One of the risk factors of glaucoma is elevated IOP, or pressure inside the eye. A healthy eye produces fluids, called aqueous humor, at the same rate fluids are drained. If the aqueous humor is not removed rapidly enough or the eye fills too rapidly, pressure builds up in the eye, which can result in glaucoma. This high pressure distorts the shape and damages the optic nerve. Maintaining healthy IOP levels may slow the progression of the disease and help prevent loss of vision.

Indication and Usage

Lumigan 0.01% and 0.03% (bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Dosage and Administration

Lumigan 0.01% offers an easy once-a-day dosing regimen. The recommended dosage is one drop in the affected eye(s) once daily in the evening. The dosage of Lumigan 0.01% should not exceed once daily since it has been shown that more frequent administration of bimatoprost may decrease the IOP-lowering effect.1

Important Safety Information

Warnings and Precautions:
Pigmentation
Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.

Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.

Intraocular Inflammation
Lumigan 0.01% and 0.03% should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. Lumigan 0.01% and 0.03% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Adverse Reactions:

In clinical studies with bimatoprost ophthalmic solutions (0.01% or 0.03%) the most common adverse event was conjunctival hyperemia (range 25% – 45%). Approximately 0.5% to 3% of patients discontinued therapy due to conjunctival hyperemia with 0.01% or 0.03% bimatoprost ophthalmic solutions. Other common events (>10%) included growth of eyelashes and ocular pruritus.

Full Prescribing Information is available at www.allergan.com.

Forward-Looking Statements

This press release contains "forward-looking statements," including statements by Drs. Whitcup and Katz, and other statements regarding the safety, effectiveness, approvals, adverse events and market potential of Lumigan 0.01%. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2009 Form 10-K and Allergan's quarterly reports on Form 10-Q for the quarters ended March 31, 2010 and June 30, 2010. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations department by calling (714) 246-4636.

About Allergan, Inc.

Allergan, Inc. is a multi-specialty health care company established 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have more than 8,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics and medical devices, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, obesity, urologics, medical aesthetics and dermatology, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

Marks owned by Allergan, Inc.

_______________________________

1 Lumigan 0.01% Prescribing Information.

2 The Glaucoma Foundation. Available at: http://www.glaucomafoundation.org/news_detail.php?id=117. Accessed April 29, 2008.

3 Glaucoma Research Foundation. "Glaucoma Facts and Stats" Available at: http://www.glaucoma.org/learn/glaucoma_facts.html. Accessed April 29, 2008.

Contact: Allergan Contacts
Caroline Van Hove (714) 246-5134 (media)
Crystal Muilenburg (714) 246-5842 (media)
Jim Hindman (714) 246-4636 (investors)
Joann Bradley (714) 246-4766 (investors)
Emil Schultz (714) 246-4474 (investors)

Posted: September 2010

View comments

Hide
(web4)