Infection from Avastin Injection Overstated, Says Study

"Eye injections of the drug Avastin, used to treat retinal diseases, bring no greater risk of endophthalmitis, a potentially blinding eye infection, than injections with the much more expensive drug Lucentis made by the same company, according to new research." That's the word from a Science Digest post. Read more.

FDA Approves Lucentis for Diabetic Retinopathy

The U.S. Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME), according to the drug's manufacturer Genentech. DME impacts nearly 750,000 Americans, about 10 percent of people with DR. The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials. For a few years, physicians have used the drug "off label" to treat DR. Read more.

The Rise of the Expensive Lucentis

"When the drug maker Genentech introduced a major product in 2006, it found itself in an awkward position: persuading eye doctors to start using its new more expensive drug instead of a popular cheaper version that the company already sold," according to a New York Times post. "Ophthalmologists had been enthusiastically using the company’s cancer drug Avastin, which cost about $50 a dose, to treat a common eye disease in the elderly, wet macular degeneration. Then Genentech introduced Lucentis, a nearly equivalent drug that cost $2,000 a dose and was approved specifically to treat the disease.Use of Lucentis took off..." Read more.

Is Vision Care a Priority? Not So

The Canadian Council of the Blind (CCB) says vision care isn't the healthcare priority it should be for the governments, given that one in four elderly Canadians will experience vision problems. The Council's poll showed more than two-thirds of Canadians feel regular eye exams and vision care should be covered as part of provincial health plans. The council also applauds provincial governments for adding Lucentis to their Drug Formularies for the treatment of Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO). CCB does not approve the use of "off label" drugs in eye treatments. We support drugs approved by Health Canada for eye conditions. A new study has raised safety issues with this use so CCB is calling on the government to ensure patient safety is put before costs by only providing the treatment approved by Health Canada. This is an example of how vision care is often not given the priority or resources it should by our health system. Read more.

Across the water in Ireland, Eircom reports that “figures from the HSE obtained by the Association of Optometrists Ireland (AOI) show the waiting time for a follow up eye examination is 47 months in Kildare. The waiting time was recently reported to be three years in Dublin and is at least two years in other parts of the country. The AOI's optometric adviser, Lynda McGivney-Nolan, said the school eye screening system was failing children - they were being treated too late and were not been tested sufficiently for reading vision difficulties.” Read more.

In the U.S., vision care for children theoretically should improve with the implementation of the Affordable Care Act (ObamaCare), which mandates coverage for children’s vision care. Many of the insurance programs in the health exchanges do not provide for refractive care for adults.

NICE Approves Lucentis for Treatment of Myopic CNV

Medical News Today reports that "in a Final Appraisal Determination (FAD) published October 25, The National Institute for Health and Care Excellence (NICE) has recommended that Lucentis (ranibizumab) be approved for use within the NHS in England and Wales as an option to treat people with visual impairment due to choroidal neovascularisation associated with pathological myopia (myopic CNV)6. Myopic CNV is the growth of abnormal leaky blood vessels in the back of the eye in high myopia (severe near sightedness)." Read more.

New Drug Treatment for AMD

Medical News Today says that “a team of ophthalmologists at the University of Iowa has shown that a third drug, Eylea, can ease leaking and vision problems for wet AMD patients. In a study involving 31 AMD patients at the UI Hospitals and Clinics, researchers report that half of the eyes treated with Eylea had reduced fluid after three monthly injections. Moreover, in some cases subsequent bimonthly injections with Eylea were deemed as effective as monthly injections of Avastin and Lucentis over a similar time period, meaning fewer visits by patients and less cost.” Read more.

AMD Genes Don't Predict Response to Lucentis or Avastin

“New findings from a landmark clinical trial show that although certain gene variants may predict whether a person is likely to develop age-related macular degeneration (AMD), a potentially blinding eye disease that afflicts more than nine million Americans, these genes do not predict how patients will respond to Lucentis and Avastin, the two medications most widely used to treat the 'wet' form of AMD,” says Science Daily. “This new data from the Comparison of AMD Treatment Trials (CATT), published online in Ophthalmology, the journal of the American Academy of Ophthalmology, found no significant association between four gene variants and outcomes that measured the patients' responses to treatment.” Read more.

Lucentis Approved to Treat Diabetic Macular Edema

"The U.S. Food and Drug Administration...gave its approval to the drug Lucentis as a treatment for diabetic macular edema (DME), making it the first medicine approved for the ailment," reports U.S. News and World Report. "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." Read more.

FDA Committee Approves Use of Lucentis for DME

Genentech says the U.S. Food & Drug Administration (FDA) Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously to recommend approval of the 0.3 mg dose of Lucentis (ranibizumab injection) for treatment of diabetic macular edema (DME). The majority of DODAC (8-2) also recommended the 0.5 mg dose. The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so. Read more.

The Consequences of the Avastin/Lucentis Debate

"For both drugs, vision was slightly better with monthly injections, rather than with less frequent or "as-needed" injections. However, study authors were also quick to note that since as-needed dosing requires fewer drug injections into the eye, some patients, following consultation with their eye doctor, may elect not to choose monthly injections, balancing relative risks and cost." Read more on Medical News Today.

NEI Weighs In on the Avastin-Lucentis Debate

At two years, Avastin (bevacizumab) and Lucentis (ranibizumab injection), two widely used drugs to treat age-related macular degeneration (AMD), improve vision when administered monthly or on an as needed basis, although greater improvements in vision were seen with monthly administration for this common, debilitating eye disease, according to researchers supported by the National Institutes of Health.

Avastin and Lucentis Yield Similar Improvements, Says Study

Two drugs commonly used to treat age-related macular degeneration (AMD) yield similar improvements in vision for patients receiving treatments on a monthly or as-needed basis, according to a study from researchers at the Center for Preventive Ophthalmology and Biostatistics (CPOB) at the Perelman School of Medicine at the University of Pennsylvania. The year-two results of the Comparison of AMD Treatment Trials (CATT) support the findings from the first year of the study that evaluated the effects of Avastin (bevacizumab) - the off-label drug most frequently used to treat AMD - and Lucentis (ranibizumab), a drug approved by the FDA in 2006 for the treatment of AMD. Full long-term results of the CATT, a two-year clinical trial, are published in the current issue of Ophthalmology. Read more.

UK's NICE Reject Lucentis

"Novartis AG's (NVS) eye care drug Lucentis has been rejected by Britain's health costs watchdog because of the medicine's high cost and doubts about its effectiveness in treating macular oedema," according to a Wall Street Journal post. "Macular oedema occurs when fluid collects in the retina, causing damage to vision. The U.K.'s National Institute for Health and Clinical Excellence, or NICE, Thursday said its independent appraisal committee was unable to recommend the injectable therapy "because of gaps and uncertainties in the evidence on the effectiveness of Lucentis compared with other treatments" and because of the drug's cost." Read more.

NSAID and Lucentis Could Help with AMD

According to a paper published in the September issue of Retina, The Journal of Retinal and Vitreous Diseases, a pilot study suggests that the topical nonsteroidal anti-inflammatory (NSAID) eye drop of Xibrom  (bromfenac ophthalmic solution) 0.09%, administered twice daily may have an additive effect when used with intravitreal Lucentis (ranibizumab injection) in reducing retinal thickness in neovascular age-related macular degeneration, or NV AMD.Read more of the company's press release.

Brits Don't Approve Lucentis

MedicalNewsToday reports that "NICE (National Institute for Clinical Excellence) in the UK has decided not to recommend Lucentis (ranibizumab) for diabetic macular edema (British spelling: oedema) treatment. NICE approves or turns down treatments that will be covered by the NHS (National Health Service), the UK's universal health care system. Patients will still be able to get Lucentis prescriptions for diabetic macular edema, but at a much higher personal cost (private prescription)." Read more.

Lucentis Helps Improve Vision

The National Eye Institute announced the results of a Lucentis trial:

Evidence has accumulated that abnormal blood vessel growth in diabetic retinopathy is caused by a protein, vascular endothelial growth factor (VEGF). This trial compared the effectiveness of laser therapy alone to laser therapy combined with Lucentis, a drug that prevents VEGF from stimulating abnormal blood vessel growth. The study involved 690 patients at 52 clinical sites within the DRCR.net. Nearly 50 percent of patients who received the combination of Lucentis and laser treatment experienced substantial visual improvement after one year, compared with only 28 percent who received laser treatment alone.

Lucentis-Avastin Debate Still Rages

MedicalNewsToday weighs in on the Lucentis-Avastin debate: "Genentech (Hoffman - La Roche) manufactures two critically important pharmaceuticals, Lucentis and Avastin, which are both used for treatment of several common eye diseases - including age-related macular degeneration (AMD). Despite considerable clinical similarity, the price difference between these drugs is substantial, with Lucentis generally costing up to 100 times the equivalent treatment with Avastin. A National Institutes of Health (NIH) clinical trial titled, "Comparison of AMD Treatment Trials" (CATT), is currently under way to compare the safety and efficacy of the two drugs, and the results may have far-reaching economic implications for Genentech, patients, Medicare, and third party payors."