Healthcare Industry News: Macugen
News Release - January 29, 2010
Study Published in the American Journal of Ophthalmology Examines Investigational Use of Macugen in Patients With Branch Retinal Vein Occlusion (BRVO)PALM BEACH GARDENS, FL., Jan 29 --(HSMN NewsFeed)-- Eyetech Inc. announced today the results of a preliminary study assessing the investigational use of Macugen for macular edema secondary to branch retinal vein occlusion (BRVO) that were published in the January issue of the American Journal of Ophthalmology (AJO). The uncontrolled, dose-finding study showed that half of the patients in the study (N=20) gained at least 3 lines of vision by 30 weeks with Macugen injections administered at 6-week intervals, and patients maintained these improvements for the duration of the 54-week study. The response was shown to be rapid after the first injection, with a mean improvement of approximately 2 lines of vision after 1 week. Investigators also observed a reduction in retinal thickness and macular volume at both 0.3 mg and 1.0 mg doses of Macugen, suggesting a positive effect.
"This small study provides early and encouraging evidence that Macugen may be an effective option for the treatment of BRVO," said John Wroblewski, M.D., lead author of the paper. "While these findings are promising, randomized and controlled clinical trials are needed to evaluate the efficacy, optimal treatment interval and duration, and safety of Macugen in patients with BRVO."
After 54 weeks and a mean number of Macugen injections of 7.2, the mean best-corrected visual acuity (BCVA) improved 14 letters over baseline, mean center point thickness decreased 205 Ám, and mean macular volume decreased 2.2 mm3. Similar improvements in mean BCVA were seen with the 0.3 mg and 1 mg doses. At week 1, 47% of eyes had gained at least 10 letters and 18% had gained 15 letters or more. At week 30, 50% of eyes had gained 15 or more letters. These improvements were sustained at 54 weeks.
One retinal detachment and no cases of endophthalmitis or traumatic cataract were seen in the study. There was also no evidence of a sustained effect on intraocular pressure or of an increased risk of systemic adverse events related to VEGF inhibition detected.
About the Study
The study, entitled "Pegaptanib Sodium for Macular Edema Secondary to Branch Retinal Vein Occlusion," was a prospective, randomized, dose-finding non-controlled study conducted at three clinical practices in the United States. Twenty patients who had a 1 to 6 month history of macular edema secondary to BRVO were randomized to receive intravitreal injections of either 0.3 mg Macugen (N=15) or 1 mg Macugen (N=5) at baseline and at weeks 6 and 12, with subsequent injections at 6-week intervals at investigator discretion until week 48. Principal efficacy outcomes were: change from baseline to week 54 in BCVA, center point thickness, central subfield thickness, and macular volume as measured by optical tomography.
About Retinal Vein Occlusion (RVO)
Retinal vein occlusion (RVO) is a blockage in the blood supply from the retina, causing swelling (macular edema) and hemorrhages which often leads to sudden blurring or vision loss in all or part of one eye. It is second only to diabetic retinopathy as a cause of vision loss due to retinal vascular disease. There are two types of RVO: branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). BRVO occurs when one of the branches of the main vein is blocked and CRVO occurs when the main vein of the eye is blocked. Most retinal vein occlusions occur after age 50, although younger patients are sometimes seen with this disorder. The highest rate of occurrence is in individuals in their 60's and 70's.
Macugen, a selective inhibitor of VEGF-165, is approved in the United States for the treatment of neovascular age-related macular degeneration (neovascular AMD) and is administered in a 0.3-mg dose once every six weeks by intravitreal injection. 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 pathological processes that contribute to the vision loss associated with neovascular AMD.
Eyetech Inc. markets and sells Macugen in the United States, and Pfizer Inc. markets and sells Macugen outside of the United States. For full prescribing information about Macugen, please visit http://www.Macugen.com/.
Important Safety Information
Macugen is contraindicated in patients with ocular or periocular infections or with known hypersensitivity to pegaptanib sodium or any other excipient of this product.
Safety or efficacy of Macugen beyond two years has not been demonstrated.
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.
Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in postmarketing experience following the intravitreal administration procedure.
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 two 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.
About Eyetech Inc.
Eyetech Inc. is a unique, independent 100% employee-owned and operated biotechnology company dedicated exclusively to the treatment of sight-threatening diseases of the retina. For more information about Eyetech, please visit http://www.eyetech.com/.
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