Allergan Announces FDA Issues Approvable Letter for COMBIGAN™ (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
IRVINE, Calif.--(BUSINESS WIRE)--Allergan Inc. (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter for COMBIGAN™ (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. An approvable letter outlines the remaining conditions that a company must meet in order to obtain FDA final marketing approval.
“In its approvable letter, the FDA suggested an additional confirmatory study to address certain questions posed by the Agency. Allergan already commenced a clinical study at the end of 2005 that addresses the remaining FDA questions.”
“We remain committed to the program and to working diligently with the FDA on any remaining issues,” said Scott M. Whitcup, M.D., Allergan’s Executive Vice President, Research and Development. “In its approvable letter, the FDA suggested an additional confirmatory study to address certain questions posed by the Agency. Allergan already commenced a clinical study at the end of 2005 that addresses the remaining FDA questions.”
COMBIGAN™ includes two agents known to reduce IOP – ALPHAGAN® (brimonidine tartrate ophthalmic solution 0.2%) and timolol ophthalmic solution 0.5%, a beta-blocker – in one drop. COMBIGAN™ is approved and marketed in Europe, Canada, Brazil and Australia. Glaucoma currently affects approximately three million people in the United States and 65 million people worldwide1 and is the leading cause of preventable blindness in the United States.2 Elevated IOP, or pressure inside the eye, represents a major risk factor for vision loss associated with glaucoma; the higher the IOP, the greater the likelihood of optic nerve damage, which can lead to vision loss and potential blindness. Reducing elevated IOP is the only treatable glaucoma risk factor.
About Allergan, Inc.
With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
This press release contains "forward-looking statements", including the statements by Dr. Scott Whitcup and other statements regarding the potential FDA approval of COMBIGAN™ and the potential outcome of ongoing studies of COMBIGAN™. 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 conditions; challenges inherent in the research and development and regulatory processes; and governmental laws and regulations affecting domestic and foreign operations. Accordingly, Allergan can give no assurance that COMBIGAN™ will be approved by the FDA. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan’s public periodic filings with the Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Allergan’s 2005 Form 10-K for fiscal year 2005 and Allergan’s Form 10-Q for the quarter ended September 29, 2006. Copies of Allergan’s 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 by calling 1-714-246-4636.
1 Glaucoma Research Foundation Web Site. "Glaucoma Facts and Stats" http://www.glaucoma.org/learn/glaucoma_facts.html.
2 The Glaucoma Foundation. “TGF Urges Eye Exams to Detect the Disease Early” January 8, 2006. http://www.glaucomafoundation.org/news_story.php?i=38.