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Pegaptanib effective against neovascular AMD at 1 year, studies find
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Pegaptanib appears to be an effective therapy for neovascular age-related macular degeneration, according to a study recently published in the New England Journal of Medicine.
The study reports 1-year results of two concurrent trials of pegaptanib, which received U.S. regulatory approval in December as Macugen (pegaptanib sodium injection, Eyetech Pharmaceuticals, Pfizer) for the treatment of all subtypes of wet AMD. The long-term safety of the drug has not yet been established, the study authors noted.
Evangelos S. Gragoudas, MD, and colleagues in the VEGF Inhibition Study in Ocular Neovascularization (VISION) Clinical Trial Group conducted the concurrent, prospective, randomized, multicenter clinical trials.
Intravitreous injections of 0.3 mg, 1 mg or 3 mg of pegaptanib or sham treatment were administered every 6 weeks over a period of 48 weeks. The primary endpoint was the percentage of patients who lost fewer than 15 letters of visual acuity at 54 weeks.
Efficacy was demonstrated, with no dose-response relationship, for all three doses investigated, according to the published study.
Trials were conducted at 117 sites in Australia, Canada, Europe, Israel, South America and the United States. To be included, patients had to be at least 50 years old and have subfoveal choroidal neovascularization secondary to AMD with a range of best corrected visual acuity of 20/40 to 20/320 in the study eye and of 20/800 or better in the contralateral eye. A total of 1,208 patients were enrolled; at least 1,190 received at least one study treatment.
Among patients receiving the 0.3 mg dose of pegaptanib, 70% lost fewer than 3 lines of vision at 54 weeks, compared with 55% of patients in the control group.
According to a press release from Pfizer, the co-marketer of Macugen, “further analysis showed that the results were consistent regardless of disease subtype and lesion size, and Macugen reduced the risk of progression to legal blindness in the treated eye by half at the end of 1 year.” The per-injection rates of endophthalmitis, retinal detachment and traumatic lens injury were similar to rates identified in a comprehensive review of more than 15,000 intravitreous injections, the study authors said.