FDA Approves Lucentis For Wet Age-Related Macular Degeneration

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Main Category: Eye Health / Blindness
Article Date: 30 Jun 2006 - 20:00 PDT

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The FDA has approved Lucentis (ranibizumab) for the treatment of neovascular wet age-related macular degeneration (AMD). 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 means its active ingredient has been approved for the first time in the USA.

Lucentis will also be the first product approved by the FDA which provides prescription information in the new format for prescription drug package inserts. This gives health care professionals and patients clear and easy to follow prescription information.

Dr. Andrew von Eschenbach, Acting Commissioner of Food and Drugs, 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."

AMD is a significant cause of blindness for people over 55. People with untreated wet AMD eventually 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.

Lucentis is given by ocular administration - injection into the eye. Clinical trials showed that almost 95% of patients with wet AMD suffered no vision loss for 12 months with Lucentis treatment. This compared to 60% of patients who were on a placebo. 30% of the Lucentis-treated patients actually experienced improved vision after 12 months.

A smaller trial showed Lucentis protected wet AMD patients' vision for 24 months.

Side effects

-- conjunctival hemorrhage
-- eye pain, floaters
-- increased eye pressure
-- inflammation of the eye
Serious adverse events were rare

Lucentis is made by Genentech Inc.
http://www.gene.com

Written by: Christian Nordqvist
Editor: Medical News Today


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