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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
A landmark study by the National Institutes of Health determines that Lucentis is highly effective as a treatment for diabetic retinopathy.
Compared with laser therapy for the treatment of proliferative diabetic retinopathy, Lucentis (ranibizumab injection) was found to be an effective alternative treatment, according to a large study funded by the National Institutes of Health (NIH). An NIH press release attests that “the findings demonstrate the first major therapy advance in nearly 40 years.”
The study examined Lucentis compared with a laser therapy called panretinal or scatter photocoagulation, which has been considered the “gold standard” treatment for retinopathy caused by diabetes since the 1970s. Lack of blood flow to the retina as a result of swelling prompts the production of vascular endothelial growth factor (VEGF) and the formation of new blood vessels in the eye-both of which can cause retinal occlusion and increased bleeding.
The study enrolled 305 participants (394 eyes) over 55 clinical trial sites, and laser therapy was compared with Lucentis injections. For those in the study who had diabetes-related retinopathy in both eyes, both treatments were given (one eye was assigned laser treatment, while the other was treated with Lucentis). Some participants were candidates for both therapies in a single eye, as the Lucentis helped clear fluid build-up in the patients in the laser group; slightly half of eyes in the laser group were given Lucentis to clear issues of diabetic macular edema.
After two years of treatment, researchers determined that Lucentis helped improved vision from baseline “by about a half a line on an eye chart” compared with virtually no improvements in vision in the laser group. Although some subjects lost some side vision with injections, there was substantial loss with side vision in the laser group. The rate of virectomy, which is a procedure used to remove excess vitreous humor in the eye, was performed fewer times in the Lucentis group.
Importantly, results from the study also suggest that Lucentis may help prevent diabetic macular edema. Among the subjects without macular edema, fewer people receiving Lucentis injections went on to develop signs of the condition than did the subjects in the laser-only group (9% vs. 28%, respectively).
First marketed as a drug to treat macular edema, Lucentis is an anti-VEGF agent. FDA expanded the approved use for Lucentis to treat diabetic retinopathy in patients with diabetic macular edema in February 2015, and the specific indication received a breakthrough therapy designation from the agency.
According to a spokesperson at Genentech, which is the manufacturer of Lucentis, the patents for the drug will begin to expire starting in 2019. Two biosimilar manufacturers, Formycon and Pfenex, already have biosimilars for Lucentis in development.