FDA Approves Ozurdex
Allergan Receives FDA Approval for Ozurdex Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease
IRVINE, Calif.--(BUSINESS WIRE)--Jun 18, 2009 - Allergan, Inc. today announced that the United States Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Retinal vein occlusion (RVO), including BRVO and CRVO, is the second most common retinal vascular disease after diabetic retinopathy1 and is a significant cause of vision loss.
Ozurdex is a first-of-its kind therapy administered via intravitreal injection delivering dexamethasone, a highly potent corticosteroid, via Allergan's proprietary and innovative NOVADUR solid polymer delivery system. Via the NOVADUR delivery system, Ozurdex, a biodegradable implant which enables the extended release and effect of dexamethasone, is placed in the vitreous cavity in the back of the eye treating the macular edema associated with RVO, thereby improving a patient's visual acuity.
With Ozurdex, patients can achieve high concentrations of dexamethasone to reduce macular edema associated with RVO, while relying on the delivery of a consistent low level of dexamethasone to maintain edema control and enhance safety.
"Ozurdex represents the first injectable, sustained-release, potent steroid implant that provides prolonged efficacy and a favorable safety profile. In the clinical studies, 20 to 30 percent of patients suffering from this severe retinal condition experienced a 3-line improvement in best-corrected visual acuity with an onset of effect within the first two months following therapy2," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. "With our nearly 60-year leadership and research investment in eye care, we are pleased to enter the retina market and provide physicians and their patients with the first FDA-approved drug treatment for macular edema following retinal vein occlusion."
The efficacy of Ozurdex was assessed in two multi-center, double-masked, randomized parallel studies involving approximately 1,300 patients. In each individual study and in a pooled analysis, time to achieve a ≥ 15 letter (3-line) improvement in best-corrected visual acuity (BCVA) cumulative response rate curves were significantly faster with the Ozurdex implant compared to sham (p < 0.01) with Ozurdex treated patients achieving a 3-line improvement in BCVA earlier than sham-treated patients.2
The onset of effect with Ozurdex, defined as a ≥ 15 letter (3-line) improvement in BCVA, occurred within the first two months after implantation in approximately 20 to 30 percent of subjects. The duration of effect persisted approximately one to three months after onset.2
"RVO is a common condition in patients 40 years of age and older and if left untreated can lead to vision loss. In the United States alone, more than 150,000 new cases of RVO are diagnosed each year3," said Mark S. Blumenkranz, M.D., professor and chairman, department of ophthalmology, Stanford University, Palo Alto, California. "This new therapy provides physicians with a meaningful advancement in treating RVO, offering a convenient option to patients through its unique extended delivery profile."
Ozurdex will be administered as an in-office procedure. The treatment is expected to be available to physicians and patients in the United States in the third quarter of 2009.
About Macular Edema Caused by Retina Vein Occlusion (RVO)
Macular edema is an eye disease where the macula swells and thickens due to fluid accumulating or leaking from retinal veins into the macula, located at the back of the eye. When the macula thickens, vision may become impaired. If swelling is caused by retinal vein leakage over a prolonged period of time, permanent visual loss may result. Macular edema may be caused by chronic diabetic retinopathy or more acute events such as RVO.
Clinical signs of RVO include hemorrhages in the retina, retinal edema or swelling, retinal vein tortuosity (twisting) and dilation, and the appearance of "cotton-wool spots" or white patches in the retina.
Systemic risk factors associated with RVO include hypertension, diabetes mellitus, cerebrovascular disease, cardiovascular disease, increased body mass index, reduced high-density lipoprotein cholesterol levels, smoking, thyroid disorder and peptic ulcer.4 Ocular risk factors associated with RVO include glaucoma or ocular hypertension, shorter axial length, and focal arteriolar narrowing and arteriovenous (AV) nicking.4
Indications and Usage
Ozurdex is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Dosage and Administration
For ophthalmic intravitreal injection only.
The intravitreal injection procedure should be carried out under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.
Important Safety Information
Ozurdex is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitits), vaccinia, varicella, mycobacterial infections and fungal diseases. It is also contraindicated in patients with advanced glaucoma and in patients with known hypersensitivity to any components of this product or to other corticosteroids.
Warnings and Precautions
Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex. Corticosteroids should not be used in active ocular herpes simplex.
The most common ocular adverse reactions reported by greater then 2% of the patients in the first six months included increased intraocular pressure (25%), conjunctival hemorrhage (20%), eye pain (7%), conjunctival hyperemia (7%), ocular hypertension (4%), cataract (4%), and vitreous detachment (3%), and headache (3%).
Full prescribing information is available at www.allergan.com.
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 approximately 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.
This press release contains "forward-looking statements", including the statements by Dr. Whitcup and Dr. Blumenkranz and other statements regarding research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding the Ozurdex implant. 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. 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 1-714-246-4636.
© 2009 Allergan, Inc. Irvine, CA 92612. ™ marks owned by Allergan, Inc.
1 Héron E., Marzac C., Feldman-Billard S., Girmens J., Paques M. , Delarue R. , Piette J., Casadevall N., Hermine, O. (2007). Endogenous Erythroid Colony Formation in Patients with Retinal Vein Occlusion. Ophthalmology, 114, Issue 12, 2155 - 2161.
2 Data on File, Allergan, Inc.
3 Data on File, Allergan, Inc.
4 Cugati, S., Wang, J. J., Rochtchina, E., & Mitchell, P. (2006). Ten-year incidence of retinal vein occlusion in an older population: the Blue Mountains Eye Study. Arch. Ophthalmol., 124, 726-732.
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: June 2009
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