Genentech, Inc.’s LUCENTIS™ (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD) has recently been approved by the USFDA.
The approval came after a Priority Review period of six months. Following the approval, Genetech started the shipment of the product.
"Lucentis provides new hope for patients with wet AMD because it is the first therapy to provide a benefit in vision for a significant number of patients," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer.
"In my opinion, the Lucentis approval stands out as one of the most important medical developments in ophthalmology during my 25 years in the field because it has the potential to reverse vision loss associated with wet AMD," said Eugene de Juan, M.D., president, American Society of Retina Specialists.
The approval of the FDA was based on data from two large PHASE III clinical trials (MARINA and ANCHOR) which resulted to the following:
-- Nearly all patients (approximately 95 percent) treated with LUCENTIS (0.5 mg) maintained (defined as the loss of less than 15 letters in visual acuity) and up to 40 percent improved (defined as the gain of 15 letters or more in visual acuity) vision at one year, as measured on the Early Treatment of Diabetic Retinopathy (ETDRS) eye chart.
-- On average, patients treated with LUCENTIS in the MARINA study experienced an improvement from baseline of 6.6 letters at two years compared to a loss of 14.9 letters in the sham group. In the ANCHOR study, patients treated with LUCENTIS, on average, experienced an 11.3 letter gain from baseline at one year compared to a loss of 9.5 letters in the Visudyne(R) photodynamic therapy (PDT) control group.
-- Up to 40 percent of patients treated with LUCENTIS achieved vision of 20/40 or better.
Read more at Genentech, Inc.
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