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? 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. ... 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 ... XOMA to Announce Second Quarter 2008 Financial Results and Host ... MarketWatch - Aug 4, 2008 ... plaque psoriasis, LUCENTIS(r) (ranibizumab injection) for wet age-related macular degeneration and CIMZIA(r) (certolizumab pegol) for Crohn's disease. ...XOMA pSivida Quarterly Highlights Business Wire (press release), CA - Jul 31, 2008 The study is designed to provide preliminary information on the potential of Medidur FA to maintain the efficacy established with Lucentis while reducing ...PSDV - ASX:PVA - ALIM New treatments for macular degeneration Casa Grande Valley Newspapers, AZ - Jul 16, 2008 Lucentis (ranibizumab), also FDA-approved, blocks all forms of VEGF. Studies have found that some patients treated with Lucentis re-gained some of the ... Wall Street Journal Blogs Q2 Earnings Coming Soon: J&J, Amgen, Merck, Pfizer and Genentech Wall Street Journal Blogs, NY - Jul 11, 2008 The eye drug Lucentis hasn?t lived up to some early expectations, largely because eye doctors figured out they can apparently get similar results much more ...AMGN - DNA Mesoblast Limited (ASX:MSB) Announce Pre-clinical Trials Show ... ABN Newswire (press release), Australia - Jul 10, 2008 ... effective at reducing blood vessel leakage after laser-induced damage as Genentech's Lucentis, the most effective FDA-approved anti-VEGF agent in use. ...ASX:MSB Genentech's Q2 2008 earnings transcript BloggingStocks - Jul 14, 2008 Our short-term growth will also be affected by our ability to obtain approvals for new indications, in particular for Avastin, Lucentis and Rituxan. ...DNA Genentech profits up 5%, Avastin/Sutent studies stopped Pharma Times (subscription), UK - Jul 15, 2008 Lucentis (ranibuzumab), for wet age-related macular degeneration, also rose 3% to $216 million, a welcome return to growth following previous declines that ...DNA Regeneron Reports Second Quarter 2008 Financial and Operating Results MarketWatch - Jul 31, 2008 In February 2008, the Company received marketing approval from the US Food and Drug Administration (FDA) for ARCALYST(R) (rilonacept) Injection for ...REGN

Wet age-related macular degeneration: FDA has approved Lucentis

The FDA ( Food and Drug Administration ) has approved Lucentis ( Ranibizumab injection ) for the treatment of patients with neovascular (wet) age-related macular degeneration ( AMD ).

Age-related macular degeneration, 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 age-related macular degeneration may become functionally impaired.
Wet age-related macular degeneration, which accounts for 10 percent of all AMD, is responsible for 80 percent of the associated vision loss.

The vision loss in wet age-related macular degeneration 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 age-related macular degeneration.
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, intraocular inflammation, retinal detachment, retinal tear, increased eye pressure and traumatic cataract.

Source: FDA, 2006