Today, the UK’s National Institute for Health and Clinical Excellence (NICE) issued a final guidance recommending Novartis’ Lucentis (ranibizumab) as an option for treating visual impairment for patients with diabetic macular edema.

After Novartis submitted a revise Patient Access Scheme and updated analyses showing the drug’s superior relative effect, NICE conducted a rapid review of the original guidance that was published in November 2011.

The final guidance recommends the drug as an option for treating visual impairment due to diabetic macular edema only if the eye has central retinal thickness of 400 micrometers or more at the start of treatment and the manufacturer provides the drug with the discount agreed in the patient access scheme revised in 2012.

NICE recommended that patients currently taking the drug whose disease does not meet the above criteria should continue treatment until they and their clinician consider it appropriate to stop.

“NICE is pleased to recommend ranibizumab as a treatment option for some people with visual impairment caused by diabetic macular edema. In November 2011, NICE published guidance which did not recommend the drug as an effective use of NHS resources. However, following the submission of a revised patient access scheme, we have conducted a rapid review of the original guidance. The manufacturer also included updated analyses showing that ranibizumab could be expected to have a superior relative effect among people with central retinal thickness greater than 400 micrometers,” Professor Carole Longson, Health Technology Evaluation Center Director at NICE said in a statement.

Ranibizumab is an injectable drug that works by preventing production of vascular endothelial growth factor (VEGF), which decreases the build-up of excessive fluid which disrupts sharp vision that can lead to severe visual impairment in the affected eye.

Source: National Institute for Health and Clinical Excellence

Last Updated: 2/27/13; 3:00PM EST

A new study suggests that people who take aspirin regularly are at a higher risk of developing neovascular (wet) age-related macular degeneration (AMD), a leading cause of blindness among people over the age of 50.

According to the report published Jan. 21 in the online edition of the journal JAMA Internal Medicine, regular aspirin users, who took aspirin once a week or more,  had almost triple the chance of developing wet AMD.  After adjusting for age, sex, smoking, history of cardiovascular disease, systolic blood pressure, and body mass index, people who took aspirin regularly had an odds ratio of developing the disease equal to 2.46 compared to those who didn’t take aspirin regularly.

The Australian study analyzed data from a 15- year prospective cohort consisting of 2,389 participants who had eye tests after five, ten and fifteen years. Almost eleven percent of the participants took aspirin regularly. Researchers found that of these regular aspirin users, almost 25 percent developed wet AMD after 15 years.

The 15-year cumulative incidence was 9.3 percent in those who were regular users compared to only 3.7 percent in nonusers. Researchers deemed these results small, but statistically significant; however study senior researcher, Jie Jin Wang, noted that these results need to be balanced with morbidity and mortality of untreated cardiovascular disease.

Currently, aspirin is one of the most effective cardiovascular disease preventives, and use has recently been associated with a decreased risk of dying from cancer; however regular use has also been associated with adverse side effects such as internal bleeding and potential risk of damaging eyesight.  An estimated 19 percent of adults in the US report using aspirin regularly, and its use increases with age.

Professor Wang said that this research is something doctors may want to discuss with patients who are at high-risk for developing wet AMD.

Furthermore, a Macular Society spokeswoman said, “The evidence is now accumulating about the association of aspirin and wet AMD, however it is not overwhelming at this point.”

“For patients at risk of cardiovascular disease, the health risks of stopping or not prescribing aspirin are much higher than those of developing wet AMD,” she said. “Patients who are taking aspirin because their doctor has prescribed it should not stop taking it without consulting their doctor first.

Wet AMD causes the patient to see a dark spot, or spots, in the center of their vision due to blood or fluid under the macula. About 1.8 million Americans are currently living with the disease.

Source: JAMA Internal Medicine

Last Updated: 1/22/13; 11:00AM EST

The National Institute for Health and Clinical Excellence (NICE) issued final draft guidance recommending Novartis’ Lucentis (ranibizumab) as an option for treatment of visual impairment related to diabetic macular oedema (DMO) after the company agreed to offer a discounted price of the drug.

Novartis submitted new analyses after NICE rejected Lucentis in 2011 because the drug didn’t provide enough benefit to justify its cost. The new analyses showed the drug’s superior relative effect for a sub-group of people with DMO. According to NICE, the drug is now recommended if the eye has a central retinal thickness of 400 micrometers or more at the beginning of treatment and if the manufacturer provides an agreed upon discounted price.

Novartis agreed to reduce the price of the drug; however the amount of the discount is confidential. Lucentis costs roughly $1,210 for each injection and is given on a monthly basis until the patient’s vision is stable for three months. The drug is already approved by NICE for treatment of wet age-related macular degeneration.

A final guidance has not yet been issued by NICE. The final guidance is expected to be published in February 2013.

“NICE is pleased to recommend ranibizumab as a treatment option for some people with visual impairment caused by diabetic macular oedema in new draft guidance. In November 2011, NICE published guidance which did not recommend the drug as an effective use of NHS resources. However, following the submission of a revised patient access scheme, we have conducted a rapid review of the original guidance. The manufacturer also included updated analyses showing that ranibizumab could be expected to have a superior relative effect among people with central retinal thickness greater than 400 micrometers,” Carole Longson, Professor and Director at the Health Technology Evaluation Center at NICE said.

According to new research, older adults who regularly use aspirin for ten years or more have an increased risk of developing an age-related eye disorder.

In a research published in the Journal of the American Medical Association, researchers found that the risk of developing wet age-related macular degeneration was roughly twice as high for those taking aspirin regularly for a decade before researchers detected in an eye exam compared with those who didn’t take aspirin regularly.

The Beaver Dam Eye Study consisted of 4,926 participants who were between the ages of 43 and 86 years old at the baseline examination. Participants had examinations every five years for a 20 year period. The participants were asked if they regularly used aspirin at least twice a week for over three months.

The authors concluded that aspirin use five years prior to observed incidence wasn’t related with incident early or late age-related macular degeneration; however regular use of aspirin ten years prior was associated with a small but statistically significant increase in the risk of incident late and neovascular age-related macular degeneration.

Aspirin is often used for pain relief as well as for cardioprotective effects. Roughly 19 percent of adults take aspirin regularly to relieve pain, arthritis and prevent heart attacks, the authors wrote. The authors said that more studies are needed to fully understand how aspirin may contribute to the eye disorder.

There are roughly 9.1 million people over the age of 40 who suffer from the condition in the US, with 90 percent having the dry type, which causes vision to slowly become blurry and the rest with the wet type, which results in all blindness from the disease.

Source: The Journal of the American Medical Association

Last Updated: 12/19/12; 11:20AM EST