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news.OSI Pharmaceuticals and Pfizer have initiated a phase IV trial that will explore the safety and efficacy of Macugen as a maintenance therapy for patients who have received prior neovascular age-related macular degeneration treatment and experienced improvement in the disease.
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Neovascular age-related macular degeneration (AMD) is a chronic, progressive disease that may require ongoing management. The 54-week trial will enroll up to 1000 patients at 100 sites across the US.
Nearly 70,000 patients have already been treated with Macugen, which offers proven efficacy and safety for up to two years in the treatment of neovascular AMD with six-week dosing. Safety may be an important consideration when choosing a maintenance therapy.
Neovascular AMD research suggests that the chronic suppression of VEGF (vascular endothelial growth factor) may be important in minimizing the risk of recurrent macular swelling and bleeding that may result in irreversible vision loss. By specifically targeting and suppressing VEGF 165, Macugen has been shown to reduce blood vessel growth and preserve vision by slowing vision loss.
“The introduction of anti-VEGF therapy marked a new era in the management of neovascular AMD, yet we still have much to learn,” said Dr Anthony Adamis, chief scientific officer, (OSI) Eyetech. “The LEVEL trial will provide further insight into Macugen's potential role in new treatment regimens for neovascular AMD.”