Eylea far better for DME patients, NIH study reports

Aflibercept is reportedly superior to ranibizumab and bevacizumab when treating some patients with diabetic macular edema (DME), according to a National Institutes of Health (NIH)-sponsored clinical trial.

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The study, published Thursday in the New England Journal of Medicine, concluded that aflibercept (Eylea, Regeneron Pharmaceuticals) was associated with greater improvements in visual acuity when compared with the other two drugs in patients who began the trial with the worst eyesight. When the initial visual-acuity loss was mild, there were no apparent differences among the groups, the study concluded.

“In this comparative-effectiveness, randomized clinical trial of center-involved DME causing decreased visual acuity, treatment with intravitreous aflibercept, bevacizumab (Avastin), or ranibizumab (Lucentis, both from Genentech/Roche) was associated with a substantial improvement in mean visual acuity by 1 month, with the improvement sustained through 1 year with the use of a standardized re-treatment protocol,” the researchers wrote. “On average, greater improvement was seen with aflibercept than with the other agents.”

The National Eye Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, and the Department of Health and Human Services also sponsored the study.

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About 660 patients with DME at 89 clinical sites were randomly assigned to receive one of the three treatments once every 4 weeks for the trial. Patients in the study averaged 61 years in age and had some form of diabetes for about 17 years.

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The primary endpoint of the study was the mean change in visual acuity from baseline to 1 year, with adjustments for baseline visual acuity.

Results showed patients in the aflibercept group had a mean improvement in best-corrected visual acuity (BCVA) from baseline of 13 letters, compared with 11 letters for the ranibizumab group and 10 letters from the bevacizumab group. Additionally, 42% of patients in the aflibercept group had improvement of at least 15 letters in BCVA versus baseline, compared with 32% of ranibizumab patients and 29% of the bevacizumab group.

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“The magnitude of the greater effect of aflibercept lacked clinical applicability because it was dependent on initial visual acuity,” the researchers noted.

However, when researchers studied patients who began the study with the worst eyesight (20/50 and worse), aflibercept presented a difference that was significant and clinically meaningful.

Patients in this subgroup analysis who had baseline visual acuity worse than 20/50 had a mean change from baseline in BCVA of 19 letters in the aflibercept group, while those in the ranibizumab group had 14 letters and those in the bevacizumab had 12 letters.

Two-thirds of patients who received aflibercept gained at least 15 letters in BCVA from baseline, as opposed to 50% of patients in the ranibizumab group and 41% of patients in the bevacizumab group.

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John A. Wells, MD, chairman of the study and a retina specialist in West Columbia, SC, told the New York Times the results seem to suggest that patients with 20/50 vision or worse could consider aflibercept as the preferred drug.

“(Aflibercept) provided significantly greater efficacy, despite one fewer injection and fewer laser treatments than comparators," said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories. "The improvements with (the treatment) relative to alternative anti-VEGF therapies were particularly apparent in the group with moderate or worse vision loss at the start of the trial, where there was a greater opportunity to demonstrate gains in vision."

Genentech released a statement Wednesday on the results, declaring that the company is looking forward to better understanding the data and whether differences in baseline characteristics influenced the results, particularly in patients with worse vision.

“Overall, for the total population, (ranibizumab) improved vision for people with DME, even with less frequent dosing (compared to labeled recommendations), and some gained up to 14 letters-nearly three lines on an eye chart, which is more than we observed in our pivotal trials for DME,” a Genentech spokesperson pointed out. “The majority of people with DME, about 75%, are diagnosed with less severe vision loss (20/40 vision or better), and the study showed that (ranibizumab) is comparable in this group of people.”

The spokesperson also noted that the difference reported between ranibizumab and aflibercept in a small group of patients with more severe vision loss has not been reported in previous studies and needs further evaluation to understand the potential impact of factors, such as the duration and severity of their diabetes and their overall health.

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“For more than 14 years, (ranibizumab’s) safety and efficacy has been studied in more than 9,080 patients, across eight pivotal and 21 clinical trials, lasting up to 5 years in wet age-related macular degeneration, macular edema after retinal vein occlusion, DME, and diabetic retinopathy in people with DME,” Genentech added in a prepared statement. “Based on the totality of evidence in support of its efficacy and well-characterized safety profile, as well as the depth and breadth of clinical experience in treating these complex retinal diseases, Genentech believes (ranibizumab) is an important treatment choice for physicians and patients.”