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NEJM research recommends use of aflibercept (Eylea) as first-line therapy in patients with a VA of 20/50 or worse

Research, published in the New England Journal of Medicine (NEJM), has concluded that aflibercept is more effective than bevacizumab and ranibizumab at improving vision for patients that present with initial visual acuity (VA) of 20/50 or worse. The study, conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) at 89 clinical sites, randomly assigned 660 adults (mean age, 61±10 years) with diabetic macular edema, involving the macular centre, to receive intravitreous aflibercept (trade name Eylea) at a dose of 2.0 mg (224 participants), bevacizumab (trade name Avastin) at a dose of 1.25 mg (218 participants), or ranibizumab (trade name Lucentis) at a dose of 0.3 mg (218 participants). The results showed that for patients presenting with mild visual acuity loss, 20/40 or better, there appeared to be no difference among the drugs in terms of improvement in the VA score or the number of injections required. In contrast, in eyes with a VA of 20/50 or worse, there was a clear advantage with aflibercept which achieved a mean improvement in VA of 19, compared to bevacizumab, with a mean improvement of 12, and ranibizumab, with a mean improvement of 14. All drugs required a similar number of injections.

 

The Diabetic Retinopathy Clinical Research Network (DRCR.net), funded by the National Eye Institute (NEI), is a collaborative network which facilitates multicenter clinical research of diabetic retinopathy, diabetic macular edema and associated conditions. The collaboration currently includes over 109 participating sites and approximately 320 physicians across the United States. An accompanying editorial in the NEJM highlighted that approximately 75% of patients with DME present with a visual acuity of 20/40 or better and, as no significant differences in safety or efficacy among drugs was found in this group, the cost of treatment then becomes a major consideration in choosing therapy. The editorial outlined that the per dose cost per patient for bevacizumab ($50), ranibizumab ($1,200), and aflibercept ($1,950), indicated that bevacizumab should be considered as “first-line therapy in patients with a visual acuity of 20/40 or better”. The situation however for patients who present with a visual acuity of 20/50 or worse, is quite different in that afliubercept is providing a clear advnatgae over bevacizumab and ranibizumab. As such the editorial recommends that “aflibercept should be considered as first-line therapy in these patients, with bevacizumab as the alternative given the lack of a significant difference in visual outcome between bevacizumab and ranibizumab and the large difference in cost between the two drugs.”

 

Commenting on the research, George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron, the manufacturer of aflibercept, stated, “in this independent, government-sponsored diabetic macular edema study, EYLEA provided significantly greater efficacy, despite one fewer injection and fewer laser treatments than comparators.  The improvements with EYLEA 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.”