Navigation Links
FDA Gives Nod to First Drug for Diabetic Eye Disease
Date:8/10/2012

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:
*Name:
*Comment:
*Email:
Related Image:
FDA Gives Nod to First Drug for Diabetic Eye Disease
(Date:10/13/2017)... EDWARDSVILLE, Ill. (PRWEB) , ... ... ... University Edwardsville School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and ... educated healthcare professionals on guideline updates for the primary prevention of cardiovascular ...
(Date:10/13/2017)... OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... or dementia. However, many long-term care insurance companies have a waiver for care if ... the 90-day elimination period, when the family pays for care, is often waived, so ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed ... geared towards children of all ages; it is a non-competitive, non-timed event, which is ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance (FHC), an ... showcase a range of technology and learning solutions at the 68th Annual American ... to be held October 14–18, 2017 at the Mandalay Bay Resort in Las ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... NEW YORK , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: ... data solutions, today announced that its MyDario product is expected to appear ... listings for when The Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, The ... ...
(Date:9/23/2017)... Janssen Biotech, Inc. (Janssen) announced today that ... U.S. Food and Drug Administration (FDA) for the Biologics ... treatment of moderately to severely active rheumatoid arthritis (RA). ... needed to further evaluate the safety of sirukumab in ... "We are disappointed ...
(Date:9/19/2017)... ANN ARBOR, Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical ... the precise destruction of targeted tissues, announced three leadership team developments today:   ... Josh Stopek, PhD ... ... Veteran medical device executive ...
Breaking Medicine Technology: