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Biotech / Medical : PSDV - pSivida Limited

PSDV 1.220

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Mar 29 5:00 PM EST

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From: John McCarthy	3/17/2010 4:49:54 PM
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VEGF TRAP shows equal efficacy to Lucentis with longer duration of effect in DME February 19, 2010 PrintSend to a FriendTweet this AnalysisAnalysis by: Andrew Dahl Analysis of: VEGF Trap-Eye Shows Positive Results in Phase II Study in Patients with Diabetic Macular Edema Published at: www.pipelinereview.com Summary Interim six month data from the DAVINCI clinical trial showed that monthly injections of intravitreal VEGF TRAP in patients with diabetic macular edema produced approximately a 10 letter increase in visual acuity. Patients dosed with 3 initial monthly injections followed as needed injections achieved a similar result. In this latter group, average number of injections in the second three months was 1.4. Injections were well tolerated without serious side effects. The study is continuing Analysis It is apparent from DAVINCI that VEGF TRAP exhibits significant beneficial effect on both retinal thickness and visual acuity in patients with diabetic macular edema. The obvious question to be asked and answered is whether Regeneron's drug is better or worse in terms of efficacy to Lucentis. In the RESOLVE trial, whose 12 month data became available in 11/2008, Ranibizumab (Lucentis) achieved approximately an 8 letter improvement at 12 months with an average of 10 injections within a year per eye. Although comparison of the studies is difficult because of dissimilar protocols, it appears that efficacy between Lucentis and VEGF Trap in DME is approximately the same, with fewer injections required for VEGF trap. One can extrapolate the data to date to conclude that VEGF trap may require 30-40% less injections on an annual basis to achieve similar efficacy. VEGF trap is 18-24 months behind Lucentis in its clinical trials for DME but had narrowed the gap from a few years ago, when it was 3-4 years behind. There is now more evidence that the ongoing View I and II trials which are designed to show non-inferiority of VEGF TRAP to Lucentis in the treatment of AMD will indeed demonstrate non-inferiorty and possible need for fewer injections (at longer intervals). Whether that will allow TRAP (after FDA approval) to penetrate Lucentis' market in the lucrative and large AMD arena remains to be seen. Analyses are solely the work of the authors and have not been edited or endorsed by GLG.Andrew Dahl consults with leading institutions through GLG Questions for the authorAndrew Dahl President , Ophthalmology Consultants Request a Consultation with Andrew Dahl Report a Concern glgroup.com

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