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news.Genentech's two Phase III trials -RISE and RIDE - of Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME) have met primary endpoints and showed that the patients who received Lucentis were able to read 15 additional letters from the eye chart as compared to the number of letters they could read at the beginning of the study.
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RISE and RIDE Phase III studies are double-masked, randomized, multicenter, sham injection-controlled, 36-month (sham injection-controlled for 24 months) and were intended to evaluate the efficacy and safety of Lucentis in patients with DME.
The results of the trial suggested that the patients who were given Lucentis, demonstrated rapid and sustained improvement in vision as compared to those who received placebo (sham) injections.
Additional data demonstrated that the patients who received Lucentis were more likely to achieve 20/40 vision and experience less progression of the underlying diabetic retinopathy disease.
Genentech intends to file a supplemental biologics license application (sBLA) with the US Food & Drug Administration for Lucentis in DME later this year.
Retina-Vitreous Associates Medical Group in Los Angeles David Boyer said these studies showed that Lucentis helped improve vision even in patients without tight glucose control, and fewer patients who received Lucentis progressed to more advanced stages of diabetic retinopathy.