Navigation Links
FDA Gives Nod to First Drug for Diabetic Eye Disease

FRIDAY, Aug. 10 (HealthDay News) -- The U.S. Food and Drug Administration on Friday gave its approval to the drug Lucentis as a treatment for diabetic macular edema (DME), making it the first medicine approved for the ailment.

According to the U.S. Centers for Disease Control and Prevention, DME occurs when fluid enters the macula, the central part of the eye's retina. This causes the macula to expand, blurring vision. Because up to 26 million Americans have either type 1 or type 2 diabetes, this eye condition is a major source of new-onset vision loss, the FDA said. In 2010, 3.9 million diabetic adults had trouble with their vision.

Laser surgery has been the only approved treatment until now for DME.

"Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema," Dr. Renata Albrecht, director of the division of transplant and ophthalmology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "Today's approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease."

Lucentis (ranibuzumab injection) is manufactured by Genentech and given via a monthly injection from a health care professional. It is meant to be taken along with proper blood sugar control, the FDA said. The drug has previously been approved to treat wet age-related macular degeneration, another major cause of vision loss in older individuals, and a condition called "macular edema following retinal vein occlusion," where a blockage of veins in the retina cause fluid to leak into the macula.

According to the FDA, Friday's approval was based on two studies involving 759 patients with DME who were treated and then followed for three years. The studies found that between 34 percent and 45 percent who received Lucentis gained at least three lines of vision on the standard eye chart test, compared to 12 percent to 18 percent of those who did not get the drug.

Side effects included bleeding in the tissue lining the inner part of the eyelids, eye pain, "floaters" and increased pressure within the eye.

More information

For more on diabetes-linked eye disease, including DME, head to the U.S. National Eye Institute.

-- E.J. Mundell

SOURCE: Aug. 10, 2012, news release, U.S. Food ad Drug Administration

Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. U.S. Gives Green Light to Publish Controversial Bird Flu Research
2. Image share project gives patients and physicians anytime, anywhere access to medical images
3. Procedure gives patients with A-fib who cant take blood thinners alternative to reduce stroke
4. UMD team gives drug dropouts a second chance
5. FDA Panel Gives Blessing to New Weight-Loss Drug
6. Amazon Tribe Gives Clues to Heart-Healthy Lifestyles
7. Killer stainless steel: New process gives icon of cleanliness antibacterial coating
8. Aurora Dentist Gives Patients Big Savings With Teeth in a Day Implants
9. OC Firm Gives Back to Young Athletes
10. Study Gives First Evidence That Adult Human Lungs Can Regrow
11. FDA Gives Nod to New Breast Cancer Drug
Post Your Comments:
Related Image:
FDA Gives Nod to First Drug for Diabetic Eye Disease
(Date:6/27/2016)... , ... June 27, 2016 , ... ... edge technology to revolutionize the emergency ambulance transport experience for the millions of ... of how Uber has disrupted the taxi industry through the use of technology. ...
(Date:6/26/2016)... ... , ... PawPaws brand pet supplements owned by Whole Health Supply ... health of felines. The formula is all-natural and is made from Chinese herbs that ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root ...
(Date:6/25/2016)... ... 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to ... a new, often overlooked aspect of head lice: the parasite’s ability to live away from ... common occurrence, but a necessary one in the event that lice have simply gotten out ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... ... crisis. Her son James, eight, was out of control. Prone to extreme mood shifts and ... him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife on ... say he was going to kill them. If we were driving on the freeway, ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Revolutionary technology includes multi-speaker listening to conquer ... in advanced audiology and hearing aid technology, has today ... world,s first internet connected hearing aid that opens up ...      (Photo: ) , ... , TwinLink™ - the first dual communication ...
(Date:6/23/2016)... -- Research and Markets has announced the ... (United States, China, Japan, Brazil, United Kingdom, Germany, France, ... Surgical Procedure Volumes: ... provides surgical procedure volume data in a geographic context. ... analysis of growth drivers and inhibitors, including world population ...
(Date:6/23/2016)... , June 23, 2016  The National ... has joined the health policy research organization as ... Romano , MD, senior vice president and chief ... company,s representative on the NPC Board of Directors. ... pleased that Mallinckrodt has joined us in support ...
Breaking Medicine Technology: