Eyetech Pharmaceuticals announced yesterday approval of Macugen in Brazil for the Treatment of Neovascular Age-Related Macular Degeneration.
The therapy is being presented as the first treatment that helps preserve vision in all subtypes of neovascular AMD by slowing vision loss.
The approval for Macugen was granted by Brazil's National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária).
The therapy was approved in the United States in December 2004 and in Canada in May 2005. Eyetech and Pfizer Inc co-promote Macugen in the U.S.
Eyetech has granted Pfizer the exclusive rights to commercialize Macugen in countries outside the U.S., including Brazil, pursuant to a royalty-bearing licensing agreement.
Macugen is the first in a new class of ophthalmic drugs to specifically target vascular endothelial growth factor (VEGF), a protein that acts as a signal in triggering the abnormal blood vessel growth and leakage that is the hallmark of neovascular AMD.
Macugen specifically binds to VEGF 165, a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the primary pathological processes thought to be responsible for the vision loss associated with neovascular AMD. Thus, Macugen helps preserve vision by slowing vision loss.
Neovascular AMD is the leading cause of irreversible severe vision loss in patients older than 60 years of age in developed countries. More than 500,000 people worldwide lose their sight annually from the disease.
In Brazil, nearly 7 million people live with some form of AMD and more than 135,000 new cases are reported each year, with the incidence likely to increase significantly with a growing aging population.
Macugen is administered in a 0.3 mg dose once every six weeks by intravitreal injection. It is expected to be available in the Brazilian market later this year. Macugen has also been filed for approval in the European Union, Australia and Switzerland.
Macugen is indicated in the United States for the treatment of neovascular age-related macular degeneration, and in Canada for subfoveal choroidal neovascularization (CNV) secondary to neovascular AMD.
Macugen is a pegylated anti-VEGF aptamer, which binds to vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the pathological processes that contribute to the vision loss associated with neovascular AMD.
Macugen is contraindicated in patients with ocular or periocular infections.
Intravitreal injections including those with Macugen have been associated with endophthalmitis. Proper aseptic injection technique - which includes use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent) - should always be utilized when administering Macugen.
In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur.
Increases in intraocular pressure (IOP) have been seen within 30 minutes of injection with Macugen. Therefore, IOP as well as the perfusion of the optic nerve head should be monitored and managed appropriately.
Serious adverse events related to the injection procedure occurring in less than 1% of intravitreal injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.
Most frequently reported adverse events in patients treated for up to 2 years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased IOP, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10% to 40% of patients.
Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that specializes in the development and commercialization of novel therapeutics to treat diseases of the eye.
Eyetech's initial focus is on diseases affecting the back of the eye. Eyetech is commercializing and further developing Macugen (pegaptanib sodium injection) with Pfizer Inc for the treatment of neovascular AMD. Macugen is also being studied for other indications including diabetic macular edema and retinal vein occlusion.
Eyetech Pharmaceuticals, Inc. - www.eyetk.com
Macugen - www.macugen.com