Pegaptanib sodium safe for patients with age-related macular degeneration

May 4, 2005

Pegaptanib sodium (Macugen, Eyetech) is well tolerated in patients with age-related macular degeneration (AMD). No systemic side effects developed and any adverse events were mild, according to Anthony Capone, MD, of Royal Oak, MI. He reported the safety results of the Macugen AMD Study Group at the annual meeting of the Association for Research in Vision and Ophthalmology.

May 4

- Fort Lauderdale, FL - Pegaptanib sodium (Macugen, Eyetech) is well tolerated in patients with age-related macular degeneration (AMD). No systemic side effects developed and any adverse events were mild, according to Anthony Capone, MD, of Royal Oak, MI. He reported the safety results of the Macugen AMD Study Group at the annual meeting of the Association for Research in Vision and Ophthalmology.

Patients received an intravenous injection of pegaptanib sodium every 6 weeks for 54 weeks, and they were evaluated for adverse events, inflammation, intraocular pressure, visual acuity, and blood pressure. Patients had received a mean of 9.6 doses at the end of treatment.

Dr. Capone reported that there was no change in blood pressure over the course of the study and there was no significant worsening from baseline in urinalysis parameters.

"Most of the adverse events were ocular in nature. About 95% of the patients had an ocular adverse event. Most were mild and related to the injection procedure. The most frequent were pain, punctate keratitis, and vitreous floaters. No endophthalmitis, retinal detachment, or traumatic cataract occurred. Transient increases in intraocular pressure developed but were mild and did not result in discontinuation of the drug. Mild anterior chamber inflammation occurred in 7% of patients. Eighteen patients lost 20 or more letters, which was consistent across the study groups," he said. Six deaths occurred, but none were considered related to the study drug.

"Systemic levels of pegaptanib were low. There is no accumulation of the drug over time and no evidence of systemic vascular endothelial growth factor inhibition. There was no clinically significant ocular inflammation. Most ocular adverse events were mild. Adequate drug levels were maintained for 6 weeks at the 0.3 mg dose, which is the dose recommended from the clinical trial. The therapeutic index of the drug seems to be quite favorable," he concluded.