(OSI) Eyetech, Pfizer launch phase IV pegaptanib maintenance trial in neovascular AMD

(OSI) Eyetech Pharmaceuticals Inc. and Pfizer Inc. have initiated a phase IV trial that will study whether use of pegaptanib sodium injection (Macugen) following neovascular age-related macular degeneration (AMD) therapy provides a balance in long-term safety and efficacy. Called LEVEL (EvaLuation of Efficacy and safety in maintaining Visual acuity with sEquential treatment of neovascuLar AMD), the 54-week trial will comprise up to 1,000 patients at 100 sites across the country.

Nearly 70,000 patients have been treated already with pegaptanib sodium, which offers proven efficacy and safety for up to 2 years in the treatment of neovascular AMD with 6-week dosing. According to retrospective Medicare data, patients with neovascular AMD are typically older, with significantly more co-morbid conditions such as hypertension, diabetes, lipid disorders, stroke, and heart attack than those who do not have neovascular AMD.

"Armed with a growing number of treatment options, we should explore new regimens that may be capable of providing beneficial patient outcomes while addressing long-term safety and dosing considerations," said Thomas R. Friberg, MD, professor of ophthalmology and bioengineering at the University of Pittsburgh Medical Center, and a lead investigator in the LEVEL trial.

Neovascular AMD research suggests that 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, pegaptanib sodium has been shown to reduce blood vessel growth and preserve vision by slowing vision loss. In addition, pegaptanib sodium has an excellent long-term safety profile that has been evaluated in controlled clinical trials up to 2 years. Patients were then followed for a third year of treatment in an uncontrolled extension study.

"The introduction of anti-VEGF therapy marked a new era in the management of neovascular AMD, yet we still have much to learn," said Anthony P. Adamis, MD, chief scientific officer, (OSI) Eyetech. "Macugen has proven efficacy and safety. The LEVEL trial will provide further insight into the potential role of pegaptanib sodium in new treatment regimens for neovascular AMD."