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Lucentis News

FDA Approves Genentech’s Lucentis (ranibizumab) for all Forms of Diabetic Retinopathy

Posted 19 Apr 2017 by Drugs.com

South San Francisco, CA – April 17, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among adults aged 20 to 741 and affects nearly 7.7 million people in the U.S.2 With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye. In February 2015, Lucentis received FDA approval for the treatment of diabetic retinopathy in people with DME based on data from ... Read more

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

FDA Approves Genentech’s Lucentis (ranibizumab) for Myopic Choroidal Neovascularization

Posted 10 Feb 2017 by Drugs.com

South San Francisco, CA – January 5, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the U.S. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006. This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT). At three months, average visual acuity gains for patients treated with ... Read more

Related support groups: Eye Conditions, Lucentis, Myopic Choroidal Neovascularization, Ranibizumab

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

Newer Drugs Helping Older People With Eye Disease

Posted 21 May 2016 by Drugs.com

FRIDAY, May 20, 2016 – New medications are boosting quality of life for many older people with age-related macular degeneration (AMD), a new study indicates. The drugs Avastin and Lucentis have significantly increased the number of people with AMD whose vision remains good enough to do daily activities, such as read standard print or drive, researchers found. Age-related macular degeneration is the leading cause of vision loss among older Americans, the U.S. National Eye Institute (NEI) says. Ten years ago, the best available treatment for AMD was photodynamic therapy, which used an intravenous drug and laser treatment to seal off leaking blood vessels in the eye that cause AMD, the researchers explained. However, one year after diagnosis, less than 15 percent of patients who received photodynamic therapy alone had 20/40 vision, which is typically good enough to read standard print or ... Read more

Related support groups: Macular Degeneration, Avastin, Lucentis, Visual Defect/Disturbance

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, Abnormal Glucose Tolerance, Bevacizumab, Diabetic Macular Edema, Visual Defect/Disturbance, 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, Ranibizumab, Retinopathy Prophylaxis

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, Ranibizumab, Infectious Endophthalmitis

Study Compares Drugs for Diabetes-Linked Eye Disease

Posted 18 Feb 2015 by Drugs.com

WEDNESDAY, Feb. 18, 2015 – A vision-robbing condition called diabetic macular edema can strike people with diabetes. Now, a new study compared three leading drugs for the condition – Avastin, Eylea and Lucentis – and found that Eylea came out on top, at least for patients with "moderate" vision loss. The study, funded by the U.S. National Eye Institute (NEI), "will have a dramatic impact on patient care," said Dr. Mark Fromer, an ophthalmologist at Lenox Hill Hospital in New York City. He was not involved in the new research. According to the NEI, about 750,000 Americans suffer from diabetic macular edema. The condition occurs in people with a type of diabetes-related eye disease called diabetic retinopathy. "Diabetic macular edema is the most common reason for visual loss in the 7.7 million Americans with diabetic retinopathy," Fromer noted. "Macular edema occurs when abnormal blood ... Read more

Related support groups: Eylea, Lucentis, Diabetic Retinopathy, Diabetic Macular Edema, Retinopathy Prophylaxis

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

Lucentis Approved for Diabetic Macular Edema

Posted 10 Aug 2012 by Drugs.com

FRIDAY, Aug. 10 – Lucentis (ranibizumab injection) has been approved by the U.S. Food and Drug Administration to treat diabetic macular edema (DME), an eye condition that could threaten a diabetic person's sight, the agency said Friday in a news release. The condition occurs when fluid leaks into the macula, the center of the eye's retina. This leads to macular swelling, causing blurred vision. Diabetes is the leading cause of new cases of blindness among people aged 20 to 74, the FDA said, citing statistics from the U.S. Centers for Disease Control and Prevention. Commonly reported side effects of Lucentis include bleeding of the eye's conjunctiva tissue, eye pain, floaters and increased pressure inside the eye. Lucentis, marketed by San Francisco-based Genentech, was approved previously for wet age-related macular degeneration, and another form of macular edema. More information The ... Read more

Related support groups: Lucentis, Macular Edema

Eye Antibiotics Can Cause Drug-Resistant Bacteria: Study

Posted 12 Sep 2011 by Drugs.com

MONDAY, Sept. 12 – Repeated use of antibiotics among patients who receive eye injections for such ophthalmic conditions as age-related macular degeneration can lead to the emergence of drug-resistant germs, according to a new study. More than eight million people in the United States are affected by age-related macular degeneration, and its treatment involves monthly injections that are typically followed by antibiotics to prevent such complications as inflammation of the eye. Researchers from Vanderbilt University School of Medicine in Nashville found, however, that long-term use of antibiotics after eye injection therapy may promote the growth of hard-to-treat germs. "Repeated exposure of ocular flora [microbes living on or inside the body] ... may select for resistant bacterial strains and cultivate 'superbugs' with multiple-drug resistance ..." the study's authors wrote a news ... Read more

Related support groups: Macular Degeneration, Vigamox, Zymar, Sulfacetamide Sodium, Povidone Iodine, Boric Acid, Azasite, Lucentis, Stye, Polytrim, Polymyxin B/Trimethoprim, Tobrex, Silver Nitrate, Ciloxan, Ocuflox, Natacyn, Zymaxid, Zirgan, Besivance, Trifluridine

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

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Macular Degeneration, Diabetic Retinopathy, Macular Edema, Diabetic Macular Edema, Myopic Choroidal Neovascularization

Lucentis Patient Information at Drugs.com