The experimental drug ranibizumab (Lucentis™, Genentech) has improved vision in patients with the “wet” form of age-related macular degeneration (AMD), a serious eye disease of the elderly. In a one-year trial, vision improved on an eye chart in 25% to 34% of patients; only 5% of patients receiving a placebo improved by the same amount.
Lucentis™ appears to be the first drug that can improve vision in patients with AMD; until now, other treatments have been able to only slow or stabilize the condition.
In May, Genentech reported preliminary data but did not state the percentage of improvement. Some researchers also questioned whether the studied patients were representative of AMD patients in general. In one trial, the drug was associated with an elevated risk of uveitis.
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Lucentis™ is a modified form of the company’s cancer drug bevacizumab (Avastin), which blocks protein factors that promote the growth of blood vessels. Bevacizumab is not readily absorbed into the retina; thus, Lucen-tis™ was developed as a separate drug. Genentech and some doctors say that risks associated with the drug should be minimal, because Lucentis™ is injected directly into the eye instead of being administered systemically, like bevacizumab.
Genentech plans to ask the FDA to grant “fast-track” status to win an earlier approval based on the one-year data, although Lucentis™ is unlikely to win regulatory approval until at least mid-2006.