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Ranibizumab News

FDA Approves Genentech’s Lucentis (Ranibizumab Injection) Prefilled Syringe

Posted 17 Oct 2016 by Drugs.com

South San Francisco, CA – October 14, 2016 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis (ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine. Like the Lucentis 0.5 mg vial, the 0.5 mg PFS is approved to treat people with wet age-related macular degeneration (AMD) and macular edema after retinal vein occlusion (RVO). The Lucentis PFS is the first syringe prefilled with an anti-VEGF medicine FDA-approved to treat two eye conditions. “The FDA approval of the Lucentis prefilled syringe marks a new milestone in our ongoing commitment to people affected by vision-threatening eye diseases,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With the PFS, physicians will have a new option for adm ... Read more

Related support groups: Macular Degeneration, Lucentis, Macular Edema, Ranibizumab

Study Compares Drugs for Common Diabetic Eye Disease

Posted 29 Feb 2016 by Drugs.com

MONDAY, Feb. 29, 2016 – People with diabetes are at risk for blurred vision or even a loss of vision from a condition called macular edema. Three drugs for the disease – Avastin, Eylea and Lucentis – vary widely in price, but new research suggests all work equally well for patients with mild vision loss. However, when diabetic macular edema leads to more severe vision loss, researchers found Eylea to be the better choice. The study, funded by the U.S. National Eye Institute (NEI), "will help doctors and their patients with diabetic macular edema choose the most appropriate therapy," study lead author Dr. John Wells said in an institute news release. "The study suggests there is little advantage of choosing Eylea or Lucentis over [much cheaper] Avastin when a patient's loss of visual acuity from macular edema is mild, meaning a visual acuity of 20/40 or better," Wells explained. ... Read more

Related support groups: Eye Conditions, Macular Degeneration, Avastin, Eylea, Diabetes Mellitus, Lucentis, Macular Edema, Bevacizumab, Abnormal Glucose Tolerance, Visual Defect/Disturbance, Diabetic Macular Edema, Ranibizumab, Aflibercept

Drug Lucentis May Fight Diabetic Eye Disease

Posted 13 Nov 2015 by Drugs.com

FRIDAY, Nov. 13, 2015 – The injected drug Lucentis (ranibizumab) appears highly effective at treating proliferative diabetic retinopathy, a common diabetes-related eye disease, new research shows. Investigators say the drug beat a standard treatment, laser therapy, in curbing the vision-robbing ailment. The findings, "provide crucial evidence for a safe and effective alternative to laser therapy against proliferative diabetic retinopathy," NEI Director Dr. Paul Sieving said in a news release from the U.S. National Eye Institute (NEI). The study was funded by the NEI, which described Lucentis as the first major advance in therapy for proliferative diabetic retinopathy in nearly 40 years. The trial was conducted by the Diabetic Retinopathy Clinical Research Network. The results were published online Nov. 13 in the Journal of the American Medical Association and they are also slated for ... Read more

Related support groups: Lucentis, Diabetic Retinopathy, Retinopathy Prophylaxis, Ranibizumab

Drug Avastin Not Linked to Higher Risk of Blindness: Study

Posted 13 Aug 2015 by Drugs.com

THURSDAY, Aug. 13, 2015 – Concerns that eye injections of the drug Avastin increase the risk of a potentially blinding eye infection may be unfounded, a new study finds. Researchers analyzed insurance claims data from across the United States to compare the use of Avastin (bevacizumab) to treat retinal diseases with a much more expensive drug called Lucentis (ranibizumab). The study was conducted in response to reports of Avastin-related eye infections that led the U.S. Food and Drug Administration to propose tight restrictions on the use of the drug for eye conditions. But the findings showed that patients treated with Avastin do not have a higher risk of an eye infection called endophthalmitis than those treated with Lucentis, the study authors said. The researchers looked at more than 296,000 injections of Avastin and more than 87,000 injections of Lucentis. They found the rates of ... Read more

Related support groups: Eye Conditions, Avastin, Lucentis, Bevacizumab, Orbital Infection, Infectious Endophthalmitis, Ranibizumab

Lucentis Approved for Diabetic Retinopathy

Posted 9 Feb 2015 by Drugs.com

MONDAY, Feb. 9, 2015 – A drug to treat the most common eye disease among diabetics has been approved by the U.S. Food and Drug Administration. Lucentis (ranibizumab) has been sanctioned to treat diabetic retinopathy, the leading cause of blindness among adults in the United States, the FDA said in a news release. In 2008, one-third of diabetic adults 40 or older had some form of diabetic retinopathy, the agency said. Lucentis, a once-monthly injection, is designed to be used with other therapies to control blood sugar, blood pressure and cholesterol, the FDA said. In some people with diabetic retinopathy who also have diabetic macular edema, abnormal blood vessels can grow and rupture on the eye's retina, leading to severe vision loss or blindness. The most common side effects of Lucentis include bleeding of the eye's conjunctiva, eye pain, eye floaters and increased eye pressure. More ... Read more

Related support groups: Lucentis, Diabetic Retinopathy, Ranibizumab

FDA Approves Lucentis as First Drug for Diabetic Retinopathy

Posted 8 Feb 2015 by Drugs.com

FRIDAY, Feb. 6, 2015 – The U.S. Food and Drug Administration on Friday approved the drug Lucentis (ranibizumab) to treat diabetic retinopathy in patients with diabetic macular edema. A leading cause of blindness among adults in the United States, diabetic retinopathy is the most common diabetic eye disease, the agency said in a news release. In 2008, 33 percent of adults with diabetes aged 40 or older had some form of diabetic retinopathy. In some patients who have diabetic retinopathy with diabetic macular edema, abnormal new blood vessels grow on the surface of the retina and if the vessels burst severe vision loss or blindness can occur, the agency said. "Diabetes is a serious public health crisis, affecting more patients every year," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "Today's approval gives ... Read more

Related support groups: Lucentis, Diabetic Retinopathy, Ranibizumab

FDA Approves Lucentis (ranibizumab) to Treat Diabetic Retinopathy

Posted 6 Feb 2015 by Drugs.com

February 6, 2015 – The U.S. Food and Drug Administration today expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME). Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years. In 2008, 33 percent of adults with diabetes aged 40 years or older had some form of DR. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. Severe vision loss or blindness can occur if the new blood vessels break. Lucentis is administered by a physician as an injection into the eye once a ... Read more

Related support groups: Lucentis, Diabetic Retinopathy, Ranibizumab

FDA Approves Lucentis (ranibizumab injection) for Treatment of Diabetic Macular Edema (DME)

Posted 13 Aug 2012 by Drugs.com

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug 10, 2012 - Genentech, a member of the Roche Group, today announced that Lucentis (ranibizumab injection) was approved by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema (DME), an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness. Diabetes is now the leading cause of new cases of blindness in American adults1 and DME is estimated to affect more than 560,000 Americans with the disease.2 Lucentis is the first and only FDA-approved medicine for DME, a condition for which the standard of care has not changed significantly in more than 25 years. To date, the standard of care in the U.S. for DME has been laser surgery, which slows the rate of vision loss and helps stabilize vision, but has demonstrated only limited ability to restore lost vision.3 “For t ... Read more

Related support groups: Lucentis, Ranibizumab

Newer Therapies for Eye Disorder Not Tied to Heart Problems

Posted 12 Oct 2010 by Drugs.com

TUESDAY, Oct. 12 – Use of the drugs bevacizumab (Avastin) and ranibizumab (Lucentis) to treat age-related macular degeneration (AMD) doesn't appear to increase the risk of cardiovascular problems or death, a new study suggests. AMD is the most common cause of irreversible vision loss among older Americans. About 12 percent of cases are neovascular ("wet") AMD, which occurs when new blood vessels form in the eyes. Neovascular disease accounts for more than 80 percent of cases of severe vision loss in people with AMD. Bevacizumab is a chemotherapy drug that's used off-label to treat neovascular AMD. Ranibizumab is a U.S. Food and Drug Administration-approved treatment for the condition. Both drugs, which are injected into the eye and block blood vessel growth, are newer treatments for the disorder. Other approved treatments for AMD are photodynamic (laser) therapy and eye injections of ... Read more

Related support groups: Macular Degeneration, Avastin, Lucentis, Bevacizumab, Ranibizumab

FDA Approves Lucentis (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion

Posted 23 Jun 2010 by Drugs.com

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jun 23, 2010 - Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO). The FDA approved this new indication after a six-month Priority Review. "This approval provides an important new medicine for people experiencing the unexpected vision loss associated with macular edema following RVO," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. "In the Lucentis RVO clinical trials significantly more people treated with monthly Lucentis showed sustained vision improvement during the six-month study with an effect seen as early as seven days." About the Studies The BRAVO study assessed the safety and efficacy profile of Lucentis in a ... Read more

Related support groups: Macular Degeneration, Lucentis, Macular Edema, Ranibizumab

Drug a New Treatment Option for Diabetic Eye Disease

Posted 29 Apr 2010 by Drugs.com

WEDNESDAY, April 28 – A new drug may be the first new treatment in 25 years for a common diabetes-linked eye condition called diabetic macular edema (DME), researchers report. Lucentis (ranibizumab) was originally developed to treat age-related macular degeneration. But researchers say it can also improve vision in people with DME, a common form of diabetic retinopathy. The study of 691 patients with DME found that 50 percent of those who received Lucentis eye injections, plus laser treatment if necessary, had substantial improvement in vision one year after treatment, compared with 28 percent of patients who received laser treatment alone. Results were similar after two years. For 25 years, laser treatment has been the standard of care for DME, the main cause of vision loss in people with diabetes. The study, published online in the journal Ophthalmology, was conducted by the Diabetic ... Read more

Related support groups: Lucentis, Diabetic Retinopathy, Ranibizumab

Drug-Laser Combination Proves Effective For Diabetic Blindness

Posted 28 Apr 2010 by Drugs.com

Drug-Laser Combination Proves Effective For Diabetic blindness [Los Angeles Times] From Los Angeles Times (CA) (April 28, 2010) Apr. 28--For the first time in a quarter of a century, researchers have identified a new treatment for diabetic macular edema, a potentially blinding disorder that affects about 1 million Americans, researchers said Tuesday. The treatment uses a drug called ranibizumab, which when administered in combination with laser phototherapy is twice as effective at reversing vision loss as laser therapy alone. Laser therapy to prevent leakage of blood vessels in the retina has been the gold standard since it was introduced in 1985. The findings were reported online in the journal Ophthalmology. Nearly 50% of those who received both the drug and phototherapy had a visual improvement of at least two lines on an eye chart, compared with 28% of those receiving only ... Read more

Related support groups: Lucentis, Macular Edema, Diabetic Retinopathy, Ranibizumab

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Macular Degeneration, Diabetic Retinopathy, Macular Edema, Diabetic Macular Edema

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Lucentis

Ranibizumab Patient Information at Drugs.com