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Macugen® (pegaptanib sodium injection) is a novel selective anti-VEGF inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). Macugen was approved by the Food and Drug Administration (FDA) in December 2004 and has been shown to be effective for long-term use. Eyetech Inc. markets and sells Macugen in the United States and Pfizer Inc. markets and sells Macugen outside of the United States. Please visit www.macugen.com to learn more about Macugen.
Important Safety Information
MACUGEN is contraindicated in patients with ocular or periocular infections or with known hypersensitivity to pegaptanib sodium or any other excipient in this product.
Safety or efficacy of MACUGEN beyond 2 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 <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.