CardiovascularAllergan Receives FDA Approval For ACUVAIL(TM) Ophthalmic Solution For The Treatment Of Pain And Inflammation Following Cataract Surgery
Allergan, Inc. (NYSE: AGN) announced that the United States Food and Drug Administration (FDA) has approved ACUVAIL(TM) (ketorolac tromethamine ophthalmic solution) 0.45%, an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery. Cataracts are a leading cause of blindness among older adults and cataract surgery is the most frequently performed surgical procedure in the United States, with more than 3 million procedures performed each year.1
ACUVAIL(TM) is formulated at pH 6.8, enabling deionized drug delivery on the corneal surface. ACUVAIL(TM) contains carboxymethylcellulose (CMC), a viscous molecule also found in Allergan"s REFRESH(R) Brand Tears that enables the drug to adhere to the ocular surface and enhances patient comfort.
With ACUVAIL(TM), patients benefit from the drug"s comprehensive inhibition of the COX-1 and COX-2 enzymes. Studies show that those enzymes should be blocked in order to inhibit the development of prostaglandins, which are considered to be the primary s of pain and inflammation following cataract surgery.
"Building on Allergan"s 60-year expertise in eye care, we are pleased to provide physicians and their patients with an advanced and effective NSAID option for the treatment of pain and inflammation following cataract surgery," said Scott Whitcup, M.D., Allergan"s Executive Vice President, Research and Development and Chief Scientific Officer. "With its preservative-free formulation, optimized tolerability and twice-daily dosing convenience, we anticipate that ACUVAIL(TM) will be a valuable addition to the overall management of cataract surgery patients."
The efficacy of ACUVAIL(TM) ophthalmic solution was assessed in two multi-center, randomized, double-masked, parallel group comparison studies involving more than 500 patients receiving either ACUVAIL(TM) or vehicle. In the clinical studies, the efficacy of ACUVAIL(TM) was defined as complete clearance of anterior chamber inflammation measured by summed inflammation score (SOIS) and ocular pain relief following cataract extraction with posterior chamber intraocular lens (IOL) implantation. Results of these studies demonstrated that at day seven, nearly twice as many patients receiving ACUVAIL(TM) solution had an SOIS score of zero when compared to patients treated with vehicle (32 percent versus 17 percent). In addition, patients were shown to have a significantly higher incidence of clearing of anterior chamber inflammation at day 14 versus patients receiving vehicle (53 percent versus 26 percent). ACUVAIL(TM) was also shown to be significantly superior to vehicle in resolving ocular pain post-cataract surgery. On day one post-cataract surgery, the percentage of ACUVAIL(TM) patients with pain scores of zero was 72 percent, compared to 40 percent for patients in the vehicle group.
"As an ophthalmic surgeon, I rely on effective therapies that provide my patients with an optimal experience and improve visual outcomes," said Eric Donnenfeld, M.D., F.A.C.S., Ophthalmic Consultants of Long Island. "ACUVAIL(TM) is an enhanced ketorolac compound and the first preservative-free, twice-daily ophthalmic NSAID that demonstrates complete elimination of inflammation for patients undergoing cataract surgery."
ACUVAIL(TM) is expected to be available to physicians and patients in the United States in September 2009.
About Cataracts
Cataracts are a leading cause of blindness among older adults in the United States. The exact cause of cataracts is unknown. Most often, cataracts are part of the aging process. As people age, they are at greater risk of developing a cataract. More than 20 million Americans age 40 and older have cataracts and more than half of all Americans have cataracts by the time they are 80 years old.
A cataract is a clouding of the eye"s lens, which blocks or changes the passage of light into the eye. The lens of the eye is located behind the pupil and the colored iris, and is normally transparent. The lens helps to focus images onto the retina - which transmits the images to the brain. A person"s vision may become blurry or dim because the cataract stops light from properly passing through to the retina.
Risk factors for cataracts include intense heat or long-term exposure to UV rays from the sun; certain diseases, such as diabetes; inflammation in the eye; hereditary influences; events before birth, such as German measles in the mother; long-term steroid use; eye injuries; eye diseases; and smoking.
Although stronger eyeglasses or brighter lighting may help relieve symptoms of a cataract in the early stages, surgery is the only cure and the most common form of treatment. Cataract surgery is the most frequently performed surgical procedure in the United States, with more than 3 million procedures performed each year. Typically covered by medical insurance, including Medicare, the surgery is usually done as an outpatient procedure under local anesthesia. The procedure consists of an ophthalmologist making a tiny incision to remove the cloudy lens and replacing it with a permanent artificial lens.
INDICATIONS AND USAGE
ACUVAIL(TM) ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery.
DOSAGE AND ADMINISTRATION
One drop of ACUVAIL(TM) should be applied to the affected eye twice-daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of the postoperative period.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ACUVAIL(TM) solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
WARNINGS AND PRECAUTIONS
Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs. With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ACUVAIL(TM) ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening.
Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.
ADVERSE REACTIONS
The most common adverse events were reported in 1-6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred. Some of these events may be the consequence of the cataract surgical procedure.
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.
Forward-Looking Statements
This press release contains "forward-looking statements," including the statements by Dr. Whitcup and Dr. Donnenfeld, statements regarding research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding ACUVAIL(TM). 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 new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. 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 2008 Form 10-K and Allergan"s Form 10-Q for the quarter ended March 31, 2009.
© 2009 Allergan, Inc. Irvine, CA 92612. (R) and (TM) marks owned by Allergan, Inc.
1 Allergan Data on File
Allergan, Inc