PRTODAY / NewswireToday Free press release distribution service network

More news: Research
Written by / Agency / Source: Genentech, Inc.

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

FDA Advisory Committee Unanimously Recommends Approval of Lucentis for Treatment of Diabetic Macular Edema (DME) - Genentech announced that the U.S. Food & Drug Administration Dermatologic & Ophthalmic Drugs Advisory Committee voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis® for treatment of diabetic macular edema
FDA Advisory Committee Unanimously Recommends Approval of Lucentis for Treatment of Diabetic Macular Edema (DME)

 

NewswireToday - /newswire/ - Silver Spring, MD, United States, 2012/07/26 - Genentech announced that the U.S. Food & Drug Administration Dermatologic & Ophthalmic Drugs Advisory Committee voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis® for treatment of diabetic macular edema. SIX: RO, ROG; OTCQX: RHHB

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Research Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food & Drug Administration (FDA) Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (10-0) to recommend approval of the 0.3 mg dose of Lucentis® (ranibizumab injection) for treatment of diabetic macular edema (DME). The majority of DODAC (8-2) also recommended the 0.5 mg dose.

The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so.

"The committee's recommendation is an important step towards the goal of helping to redefine the standard of care for Americans with diabetic macular edema," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA¿s decision."

DME is an eye condition in people with diabetes characterized by retinal swelling and blurred vision. It is a major cause of vision loss and blindness estimated to affect more than 560,000 people in the United States.1,2 The current standard of care for DME in the U.S. is laser surgery, which primarily serves to slow the progression of vision loss and help stabilize vision.3

The DODAC recommendation was based on a review of data from Genentech's Phase III trials, RIDE and RISE, which evaluated the efficacy and safety of Lucentis in people with DME. The primary endpoint was the percentage of patients who could read an additional 15 letters or more on the standard eye chart after 24 months of treatment compared to the percentage in a control group.

Lucentis was first approved by the FDA for treatment of wet age-related macular degeneration (AMD) in 2006 and for macular edema following retinal vein occlusion (RVO) in 2010.

About RIDE and RISE
RIDE and RISE are two identically-designed, parallel, double-masked, sham treatment-controlled trials in a total of 759 patients, who were randomized into three groups to receive monthly treatment with 0.3 mg Lucentis, 0.5 mg Lucentis or sham injection (control group). Primary outcomes were evaluated at 24 months. In the third year of the studies, patients from the control group had the option to cross over to receive monthly treatment with 0.5 mg Lucentis; patients originally randomized to 0.3 mg or 0.5 mg Lucentis continued to receive the same dose and all patients were followed for 12 additional months. In an ongoing open-label extension of RIDE and RISE, all patients are eligible to receive 0.5 mg Lucentis as needed, and continue to be followed.

About DME
DME is swelling of the macula, the central part of the retina responsible for sharp, central vision.1 DME begins with diabetes, which can cause damage to blood vessels in the eye over time. When this happens, a patient is said to have diabetic retinopathy, the most common diabetic eye disease. The damaged blood vessels can leak blood and fluid, causing swelling and blurred vision and sometimes blindness.1

Among Americans aged 40 years and older, more than 4.2 million have diabetic retinopathy, according to the 20052008 National Health and Nutrition Examination Survey (NHANES) conducted by the National Center for Health Statistics.4 A subsequent analysis estimates that 560,500 have DME.2 It has also been estimated that up to 10 percent of people with diabetes will get DME during their lifetime.5

Nearly 26 million Americans have diabetes, which has become the leading cause of new cases of blindness in adults aged 20-74.6

About Lucentis

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.

In wet AMD, these new blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula. Lucentis administered monthly in wet AMD clinical trials demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) treated monthly with Lucentis in those trials maintained (defined as losing < 15 letters) vision.

In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula. In Phase III clinical trials studying macular edema following RVO, results showed that Lucentis administered monthly demonstrated an early (day seven) and sustained vision improvement of three lines or more on the study eye chart during the six-month controlled treatment period.

As of May 31, 2012, Lucentis has received regulatory approval for the treatment of visual impairment due to DME in more than 70 countries, for the treatment of wet AMD in more than 100 countries and for treatment of RVO in more than 70 countries.

Lucentis was discovered by Genentech and is being developed by Genentech and Novartis for diseases or disorders of the eye. Genentech retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.

Lucentis Safety

Lucentis is a prescription medicine given by injection into the eye, and it has side effects. Lucentis is not for everyone. Lucentis should not be used in patients who have an infection in or around the eye or are allergic to Lucentis or any of its ingredients.

Some Lucentis patients have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. Other uncommon serious side effects include inflammation inside the eye and increased eye pressure. These can make a patient's vision worse. Some patients have increases in eye pressure within one hour of an injection. A patient's eye doctor should check the eye pressure and eye health during the week after a Lucentis injection.

Uncommonly, Lucentis patients have had serious, sometimes fatal problems related to blood clots such as heart attacks or strokes.

If a patient's eye becomes red, sensitive to light, painful, or there is a change in vision, patients should call or visit their eye doctor right away.

The most common side effects in the eye are increased redness in the whites of the eye, cataracts, and eye pain, small specks in vision, and the feeling that something is in the eye. The most common non-eye-related side effects are nose and throat infections, headache, joint pain, lung/airway infections, and nausea.

Lucentis is for prescription use only.

Please visit lucentis.com for the Lucentis full prescribing information, and additional important safety information.

About Genentech

Founded more than 30 years ago, Genentech (gene.com) is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

References:
1. National Eye Institute. Facts about Diabetic Retinopathy [resource on the internet [updated 2012 Jun; cited 2012 Jun 11]. Available at: nei.nih.gov/health/diabetic/retinopathy.asp#1b.

2. Bressler NM, Varma R, Doan Q, et al. Prevalence of Visual Impairment from Diabetic Macular Edema and Relationship to Eye Care from the 2005-2008 National Health and Nutrition Examination Survey (NHANES) [abstract]. The Retina Society 45th Annual Scientific Meetings, Washington, DC; October 4−7, 2012 (accepted for presentation). NHANES database search by Genentech; data on file.

3. Early Treatment Diabetic Retinopathy Study (ETDRS) Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol 1985;103:1796-806.

4. Zhang X, Saaddine JB, Chou CF, et al. Prevalence of diabetic retinopathy in the United States, 2005¿2008. JAMA 2010; 304:649¿56.

5. Ali, F.A. A review of diabetic macular edema. Digital Journal of Ophthalmology, vol. 3, no. 6, 1997.

6. [CDC] Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention [resource on the internet; updated 2011; cited 2012 May 25].

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Research Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: Genentech, Inc.

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+] / [Company listed above is a registered member of our network. Content made possible by PRZOOM / PRTODAY indexing services]

 
 
# # #
 
 
  Your Banner Ad showing on ALL
Research articles,
CATCH Visitors via Your Competitors Announcements!


FDA Advisory Committee Unanimously Recommends Approval of Lucentis for Treatment of Diabetic Macular Edema (DME)

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

Genentech |
Publisher Contact: Press Office - Gene.com 
650-225-1000 press[.]gene.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Genentech, Inc. securities in any jurisdiction including any other companies listed or named in this release.

Research via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From Genentech, Inc. / Company Profile


Read Research Most Recent Related Newswires:

DSM-Niaga Ready for Commercial Scale Production of 100%-recyclable Carpets
DSM Dyneema Introduces Whole New Level of Cut Protection with Black Dyneema® Diamond Technology
DSM Presents Sustainable and Healthy Dairy Solutions At FoodTech 2016
Frost & Sullivan Highlights GENEWIZ's Commitment to Providing Cutting-edge Services in the Life Science Research Services Market
DSM to Present its Latest Advances in Skin Biochemistry At IFSCC Conference
DSM Launches ForTii® Ace Next Generation High Performance Polyamides
DSM Launches New Cultures to Reduce Cheese Ripening Time
DSM Launches New 3C Technology to Reinvigorate Omega-3 Supplements Category
DSM to Highlight its Health and Indulgence Solutions for Baked Goods At IBIE
DSM Welcomes EU Novel Foods Approval for Heart Health Antioxidant
DSM Dyneema Successfully Defends Key Patent Against Competitor Challenge
DSM Expands its Automotive Electronics Portfolio with High-flow Akulon PA66
BD Expands Portfolio of Reproductive and Sexually Transmitted Infections Solutions
BD Announces New Software Release for Pyxis Enterprise Solution
DSM Opens its Asia Pacific Personal Care Technical & Application Center in Shanghai

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  BizJobs.com

Visit  La Bella Bakery Artisan Bakery Arizona





 
  ©2016 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)