FDA approves Genentech’s drug for the treatment of blindness

The Food and Drug Administration has approved Genentech’s Lucentis (ranibizumab) drug for the treatment of neovascular wet age-related macular degeneration (AMD), a disease that's a major cause of blindness in people over 55.

After getting approved, Lucentis has become the first product approved by the FDA which provides prescription information in the new format for prescription drug package inserts. This offers health care professionals and patients clear and easy to follow prescription information.

A clinical study by the biotech drug maker Genentech Inc. revealed that almost 95% of patients with wet AMD suffered no vision loss for 12 months with Lucentis treatment. A considerable portion of patients had vision improve. This compared to 60% of patients who were treated with placebo. 30% of the Lucentis-treated patients actually experienced improved vision after nearly one year.

"Lucentis provides new hope for patients ... because it is the first therapy to provide a benefit in vision for a significant number of patients," said Arthur Levinson, Genentech's chairman and CEO, in a statement announcing the approval.

The once-a-month injection maintains the vision of over 90% of people with this kind of AMD. Lucentis is a new molecular entity. This denotes its active ingredient has been approved for the first time in the USA. The drug inhibits formation and leakage of new blood vessels in the back of the eye, the major cause of blindness in the disease, age-related macular degeneration.

People with untreated wet AMD ultimately become severely disabled. 10% of all AMD is wet-AMD. However, 80% of AMD associated vision loss is due to wet-AMD. With wet AMD the area of the eye responsible for central vision becomes damaged as a result of the growth of abnormal leaky blood vessels. Lucentis blocks the growth of these leaky blood vessels.

Dr. Andrew von Eschenbach, Acting Commissioner of FDA, said "This approval is of great importance for the 155,000 Americans who are diagnosed each year with AMD, a common cause of severe and irreversible vision loss in older adults. At a time when our elderly population is rapidly increasing, this product preserves quality of life for those affected by this disease, helping them to regain the ability to participate in everyday activities such as reading and driving."

The National Eye Institute reckons that 1.7 million people have the advanced form of AMD in the United States.

South San Francisco Calif. based Genentech said it would begin shipping the drug very soon and intends to market the drug to nearly 1,500 U.S. retina specialists.

Meanwhile, shares of Biotechnology Company Genentech closed higher Friday, after the FDA approved its age-related blindness treatment, Lucentis.

On the New York Stock Exchange, Genentech shares ascended $ 1.67, or 2.1%, to end the day at $ 81.80. American depositary shares of Swiss drug maker Novartis AG, which assisted Genentech with late-stage drug development in exchange for exclusive international rights to the drug, closed up 51 cents at $ 53.92.