"Based upon retinene physicians' feedback, there remains a significant unmet medical need for a intervention for wet AMD that can faithfully improve ocular acuity over time without the need for monthly intravitreal injections," said George D. "The further development of this compound is important for millions of people worldwide wHO suffer from this devastating ocular disease." Kemal Malik, fellow member of the Bayer HealthCare Executive Committee responsible for product development. Reduce retinal heaviness and meliorate vision," aforementioned Dr. "The 52-week results underline that VEGF Trap-Eye has the potential to significantly The well-nigh common adverse events were those typically associated with intravitreal injections. There was i reported case of culture-negative endophthalmitis/uveitis in the work eye and one arterial thrombotic consequence, neither of which was deemed to be drug-related. VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. Patients receiving four monthly doses of VEGF Trap-Eye, either 2.0 or 0.5 mg, for 12 weeks followed by PRN dosing thereafter, achieved mean improvements in visual acuity versus baseline of 9.0 letters (pįor all dosage cohorts combined, there was a 5.3 mean letter gather in visual acuity versus baseline at the calendar week 52 evaluation visit (p These data represent the final annual analysis from the 52-week study. Patients were monitored for safety, retinal thickness, and visual sharp-sightedness. Following the initial 12-week fixed-dosing phase angle of the trial, patients continued to receive therapy at the same zen on a PRN dosing schedule based upon the physician judgement of the need for re-treatment in accordance with pre-specified criteria. Two groups initially received monthly doses of 0.5 or 2.0 milligrams (mg) of VEGF Trap-Eye (at weeks 0, 4, 8, and 12) and three groups received quarterly doses of 0.5, 2.0, or 4.0 mg of VEGF Trap-Eye (at baseline and week 12). In this double-masked, prospective, randomized, multi-center Phase 2 trial, 157 patients were randomized to five dosage groups and treated with VEGF Trap-Eye in one eye.
#Vinnie moore discography blogspot full#
A full analysis of the 52-week results of the Phase 2 study will be presented at the 2008 meeting of the Retina Society on September 26-28, 2008 in Scottsdale, Arizona. The 32-week results of the Phase 2 study were presented at the 2008 Association for Research in Vision and Ophthalmology (ARVO) meeting in Fort Lauderdale, Florida.
The 12-week primary terminus results from the fixed-dosing period of the study were presented at the 2007 Retina Society conference in September 2007. (Nasdaq: REGN) proclaimed that patients with wet age-related macular degeneration (AMD) receiving VEGF Trap-Eye in a Phase 2 reference study on a PRN (as needful) dosing schedule continued to show highly significant improvements at 52 weeks in the primary and key secondary endpoints of retinal thickness (an anatomic measuring stick of treatment effect) and vision reach.
�Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc.
0 kommentar(er)
