Allergan, Inc., has announced that the U.S. Food and Drug Administration (FDA) has approved OZURDEX® as a new treatment option for diabetic macular edema (DME) in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). OZURDEX® is a sustained-release biodegradable steroid implant that demonstrated long-term efficacy without the need for monthly injections.[i]
DME currently impacts more than 560,000 Americans.[ii] It is an eye condition that can occur in people with diabetes (types 1 and 2) and causes fluid to leak into the part of the eye where focusing occurs (macula), causing blurred vision, vision loss and eventual blindness.[iii] The OZURDEX® implant uses the proprietary and innovative NOVADUR® solid polymer delivery system - a biodegradable implant that releases medicine over an extended period of time - to suppress inflammation, which plays a key role in the development of DME.[i]
"DME is a common cause of vision loss in patients with diabetes," said Scott M. Whitcup, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, Allergan. "OZURDEX® exemplifies our continued commitment to the development of innovative therapies for difficult-to-treat retinal diseases and offers a new treatment option to improve vision for certain patients with DME."
The FDA approval of OZURDEX® for this indication is based on the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) study. MEAD includes two multi-center 3-year sham-controlled, masked, randomized clinical studies assessing the proportion of patients with 15 or more letters improvement in best-corrected visual acuity (BCVA) from baseline. The most common adverse events in the studies included cataracts and elevated intraocular pressure (IOP). An increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles.[i]
"DME is a complicated disease to treat," said Pravin Dugel, M.D., Clinical Associate Professor of Ophthalmology, Keck School of Medicine at the University of Southern California, Managing Partner of Retinal Consultants of Arizona, and clinical investigator in the MEAD clinical trial. "OZURDEX® provides long-term improvement of DME without the need for monthly injections, which helps these patients who are also managing the other conditions common with diabetes." The OZURDEX® implant is already indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) and for the treatment of non-infectious uveitis affecting the posterior segment of the eye.[i]
About Diabetic Macular Edema
DME is a growing public health problem due to the increasing prevalence of diabetes.[iii] According to the U.S. Centers for Disease Control and Prevention, as of 2010, 25.8 million people - 8.3 percent of the U.S. population - have diabetes; 1.9 million new cases of diabetes were diagnosed in people aged 20 years or older in 2010.[iv] A high level of health care utilization is not surprising given the overall health status of this population.[v]
FDA Approved Uses for OZURDEX® (dexamethasone intravitreal implant) 0.7mg OZURDEX® (dexamethasone intravitreal implant) is a prescription medicine that is an implant injected into the eye (vitreous) and used:
- To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- To treat adults with non-infectious inflammation of the uvea (uveitis) affecting the back segment of the eye
- To treat adults with diabetic macular edema who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic).
Important Safety Information
OZURDEX® should not be used if you have any infections or diseases in the eye, or surrounding eye area, including most viral diseases of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases.
OZURDEX® should not be used if you have advanced glaucoma.
OZURDEX® should not be used if you have a posterior lens capsule that is not intact.
You should not use OZURDEX® if you are allergic to any of its ingredients.
Injections into the vitreous in the eye, including those with OZURDEX®, are associated with serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, and retinal detachments. Your eye doctor may monitor you regularly after the injection.
Use of corticosteroids may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of ocular herpes simplex.
There may be a risk of the implant moving into the front chamber of the eye if you had the posterior capsule of the lens removed or if you have a tear in the capsule.
The most common side effects reported in patients for retinal vein occlusion and uveitis include: increased eye pressure, conjunctival blood spot, eye pain, eye redness, ocular hypertension, cataract, vitreous detachment, and headache.
The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid and high blood pressure.
After repeated injections with OZURDEX®, a cataract may occur. If this occurs, your vision will decrease and you will need an operation to remove the cataract and restore your vision. You may develop increased eye pressure with OZURDEX® that will need to be managed with eye drops, and rarely, with surgery.
In the days following injection with OZURDEX®, you may be at risk for potential complications including in particular, but not limited to, the development of serious eye infection or increased eye pressure. If your eye becomes red, sensitive to light, painful, or develops a change in vision, you should seek immediate care from your eye doctor. You may experience temporary visual blurring after receiving an injection and should not drive or use machinery until your vision has resolved.
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