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:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one ... an innovative new design of the shoulder pad. The shoulder pad provides optimal ... controlling your pain while using cold therapy. By utilizing ice and water that is ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally ... care, have expanded their existing home health joint venture through an agreement, effective ... operating a joint venture home health company with Asante, delivering clinically integrated care, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. ... recently contributed a medical article to the newly revamped Cosmetic Town journal ... spotlights the hair transplant procedure known as Follicular Unit Extraction (FUE). ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s National ... 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. ... for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... Oct. 12, 2017   Divoti USA will ... to the standard of the latest FDA requirements, which stipulates new ... Anyone in need of Medical ID jewelry such as Medical ... are engraved in terms of the new FDA requirements ... Divoti offers this dark ...
(Date:10/11/2017)... Oct. 11, 2017  Caris Life Sciences ® , ... the promise of precision medicine, today announced that St. ... Precision Oncology Alliance™ (POA) as its 17 th ... St. Jude Crosson Cancer Institute will help develop standards ... of tumor profiling, making cancer treatment more precise and ...
(Date:10/10/2017)... Calif. , Oct. 10, 2017  NDS received FDA 510(k) ... — a medical-grade battery-powered display stand specifically designed for endoscopy environments. ... transform technology into a clinical solution to support the improvement of ... Innovative Design ... Mobile Wireless Solution ...
Breaking Medicine Technology: