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Published on 6/30/2006 in the Prospect News Biotech Daily.

Genentech's Lucentis receives FDA approval for treatment of wet AMD

By Lisa Kerner

Charlotte, N.C., June 30 - Genentech, Inc. said the Food and Drug Administration has approved its Lucentis (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD) following a six-month priority review.

The company expected to ship the product starting Friday, according to a news release.

Lucentis inhibits the formation and leakage of new blood vessels in the back of the eye.

According to phase 3 clinical trial results, 95% of patients treated with Lucentis maintained their vision, with 40% of patients reporting vision improvement of at least three lines (15 letters) on the study eye chart.

"Lucentis provides new hope for patients with wet AMD because it is the first therapy to provide a benefit in vision for a significant number of patients," chairman and chief executive officer Arthur D. Levinson said in a company news release.

AMD, a major cause of painless central vision loss, affects 1.7 million people in the United States.

South San Francisco, Calif.-based Genentech discovers, develops, manufactures and commercializes biotherapeutics for unmet medical needs.


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