Serious adverse events related to the injection procedure occurring in <1% of intravitreous injections included endophthalmitis (see WARNINGS), retinal detachment, and iatrogenic traumatic cataract.

The most frequently reported adverse events in patients treated with Macugen 0.3 mg for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure (IOP), ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10-40% of patients.

The following events were reported in 6-10% of patients receiving Macugen 0.3 mg therapy:

Ocular: blepharitis, conjunctivitis, photopsia, vitreous disorder.

Non-Ocular: bronchitis, diarrhea, dizziness, headache, nausea, urinary tract infection.

The following events were reported in 1-5% of patients receiving Macugen 0.3 mg therapy:

Ocular: allergic conjunctivitis, conjunctival edema, corneal abrasion, corneal deposits, corneal epithelium disorder, endophthalmitis, eye inflammation, eye swelling, eyelid irritation, meibomianitis, mydriasis, periorbital hematoma, retinal edema, vitreous hemorrhage.

Non-Ocular: arthritis, bone spur, carotid artery occlusion, cerebrovascular accident, chest pain, contact dermatitis, contusion, diabetes mellitus, dyspepsia, hearing loss, pleural effusion, transient ischemic attack, urinary retention, vertigo, vomiting.

Post-Marketing Experience: Anaphylaxis/anaphylactoid reactions including angioedema have been identified during postapproval use of Macugen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

Drug interaction studies have not been conducted with Macugen. Pegaptanib is metabolized by nucleases and is generally not affected by the cytochrome P450 system.

Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.

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