Recent News and Articles on the Keywords: lucentis + 105,000 + web  Related to the article below (Last Update: 8/5/2008)

? Macular Degeneration Clinical Trial WHOI, IL - Aug 4, 2008 In 2006, the FDA approved a new drug, called LUCENTIS? (ranibizumab), for the wet form of AMD. The drug is injected into the eye about every four weeks. ... Drug restores blind woman's sight Stuff.co.nz, New Zealand - Aug 2, 2008 Jones paid $10000 for four injections of Lucentis, a drug designed specifically for the treatment of wet macular degeneration. ... Calgary Herald Costly drug poses dilemma Calgary Herald,  Canada - Jul 28, 2008 Earlier this month, physicians treated Pyke with a new drug -- Lucentis -- that has had remarkable success in combating the effects of wet macular ... Costly drug poses dilemma Canada.com all 3 news articles » Study Looking At Treatment Of Macular Degeneration KDKA, PA - Aug 1, 2008 "Lucentis was derived from a monoclonal antibody against VEGF similar to Avastin," Martin explains. "Avastin was already FDA approved for treatment of ... Three patients who are going blind overturn NHS drug ban Telegraph.co.uk, United Kingdom - Jul 22, 2008 A course of 14 monthly injections with Lucentis can costs up to ?28000. A deal was struck between the PCT and the drug's makers Novartis so the three ... Pensioners win sight drug battle BBC News Pensioners win treatment after court battle for sight-saving drug guardian.co.uk Patients win sight treatment battle The Press Association Coventry Telegraph - UK Express all 12 news articles » Easy to see proper policy Calgary Herald,  Canada - Jul 31, 2008 Sight is a very precious gift, and that's why the Alberta government should not hesitate to fund an expensive drug called Lucentis that has shown dramatic ... Success for Coventry trio's fight on sight saving drug funding Coventry Telegraph, UK - Aug 1, 2008 SIGHT-SAVING drug Lucentis will be funded in Coventry following the success of a legal battle by three campaigners from Warwickshire. ... BBC News Call for sight treatment agreement The Press Association - Jul 11, 2008 The National Institute for Clinical Excellence (Nice) has issued a determination recommending that Lucentis should be funded by PCTs in appropriate cases, ... Patients challenge ban on sight-saving NHS treatment Telegraph.co.uk Appeal over blindness drug BBC News Warwickshire trio challenge NHS in sight treatment row Birmingham Post RedOrbit - InTheNews.co.uk all 22 news articles » Letters to the Telegraph Telegraph.co.uk, United Kingdom - Jul 27, 2008 She cannot obtain the drug Lucentis from her primary care trust to treat this disease until she contracts the condition in both eyes, by which time she ... Sight saving treatment denied Stourbridge News,  UK - Jul 30, 2008 Mrs Cheslin needs the drug Lucentis which will prevent her from going blind, but currently under Dudley PCT guidelines this treatment is not offered on the ...

FDA Approves New Biologic Treatment for
Wet Age-Related Macular Degeneration

The Food and Drug Administration (FDA) today approved Lucentis (ranibizumab injection) for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD). Lucentis is the first treatment which, when dosed monthly, can maintain the vision of more than 90 percent of patients with this type of AMD. Lucentis is a new molecular entity (NME), meaning it contains an active substance that has never before been approved for marketing in any form in the United States. Lucentis will be the first FDA--approved product to provide prescription information in the new format for prescription drug package inserts, to provide professionals and consumers clear and concise prescription information.

 "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," said Dr. Andrew von Eschenbach, Acting Commissioner of Food and Drugs. "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, a retinal disease causing severe and irreversible vision loss, is a major cause of blindness in individuals older than 55 years. Untreated, the majority of eyes affected with wet AMD may become functionally impaired. Wet AMD, which accounts for 10 percent of all AMD, is responsible for 80 percent of the associated vision loss.

The vision loss in wet AMD is caused by the growth of abnormal leaky blood vessels that eventually damage the area of the eye responsible for central vision. Lucentis is designed to block new blood vessel growth and leakiness, which ultimately lead to disease progression and such vision loss.

Lucentis, a biologic product, administered by injection into the eye, was shown to be safe and clinically effective in three multicenter, randomized studies of patients representative of the population usually affected with AMD. In clinical trials, nearly 95 percent of the participants who received a monthly injection maintained their vision at 12 months compared to approximately 60 percent of patients who received the control treatment.

Approximately one-third of patients in these trials had improved vision at 12 months. In a single study carried out for 24 months, these findings have been maintained with continued monthly dosing. The most commonly reported adverse events included conjunctival hemorrhage, eye pain, floaters, increased eye pressure and inflammation of the eye.  Serious adverse events were rare and often related to the injection procedure including endophthalmitis (severe inflammation of the interior of the eye), intraocular inflammation, retinal detachment, retinal tear, increased eye pressure and traumatic cataract.

Lucentis is manufactured by Genentech, Inc. in South San Francisco, California.