Safety & Tolerability

MACUGEN^® (pegaptanib sodium injection) has a proven safety and tolerability profile.

Excellent Patient Acceptance of MACUGEN

• In clinical studies, only 1% of patients receiving MACUGEN 0.3 mg discontinued treatment because of adverse events^1,2
• A mean of 8.4 out of a possible 9 treatments (93%), were administered to patients through 54 weeks¹
• A mean of 15.6 and 16.3 of a possible 17 treatments of MACUGEN 0.3 mg and usual care, respectively, were administered to patients through week 102¹
• 92% of all injections occurred within 1 week of the scheduled dose (MACUGEN 0.3 mg and usual care included)¹

Most Frequently Reported Adverse Events Occurring in

≥15% of Patients Receiving MACUGEN Through Week 102¹

• In clinical studies, 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 intraocular pressure (IOP), ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10% to 40% of patients¹
• Increases in 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 appropriately¹
• Only 1% of patients discontinued MACUGEN 0.3 mg due to adverse events through week 54¹
• 4% of patients from week 54 to week 102

Infrequent Serious Adverse Events

• Of 7545 injections of all 3 doses of MACUGEN given to 892 patients, serious adverse events occurred infrequently and were related to the injection procedure¹
• Serious adverse events related to the injection procedure occurring in <1% of intravitreal injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract

Serious Adverse Events Related to Injection Procedure: Patients Receiving All Doses of MACUGEN Through
Week 102

No Damage to Normal Retinal or Choroidal Vessels

• MACUGEN is a pharmacologic treatment that is not physically destructive to the retina. Throughout the studies, there was no clinical or angiographic evidence of damage to normal vasculature seen with MACUGEN¹