The sBLA submission is based on results from the RISE and RIDE Phase 3 clinical trials. Both trials investigated the safety and efficacy of Lucentis for diabetic retinopathy. A clinically significant proportion of patients treated with Lucentis demonstrated meaningful improvements in their disease at two years compared to patients given sham injections (control group). Benefits of Lucentis were maintained during the third year of treatment.
Currently there are no ocular medications approved for the treatment of diabetic retinopathy.
Lucentis is already approved for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and diabetic macular edema (DME).
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