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DewDiligence

03/08/14 7:40 PM

#175215 RE: drbio45 #175210

OPHT/REGN—…you are saying that it is no surprise that [Lucentis] treatment didn't work after treatment stopped after two years. Is it reasonable to you that the doctor who makes money everytime he gives an injection and the patient who would go blind, would voluntarily stop the treatments if they were working?

Bear in mind that we’re talking about mean values and that results vary from patient to patient. Some patients do get treatment beyond two years and continue to maintain better vision than at baseline. However, two years is a common duration of Lucentis treatment in wet AMD because that’s how long patients were treated in the phase-3 clinical trials (http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s094lbl.pdf ). There are no randomized, placebo-controlled trials in wet AMD that included treatment longer than two years.