Eric W. Schneider, MD:
Hello, I'm Eric Schneider from Nashville, Tennessee and I'm excited here to talk about some data I recently presented here at ASRS. In my talk, I discussed the primary 24 week results from the phase 3B ELARA clinical trial in which patients who were previously treated for neovascular AMD and diabetic macular edema received seven monthly aflibercept eight milligram injections through week 24, followed by a treat and extend regimen in which we assessed disease activity through week 96. Now this was primarily a safety study, but we did see meaningful anatomic and functional improvement over the 24 weeks of the study. Specifically patients in the neovascular AMD cohort gained about 2.5 letters through week 24, while those in the DME cohort gained 3.2 letters. This was accompanied by an improvement in the central subfield thickness in both groups with 27.1 microns in the neovascular AMD cohort and 39.7 microns in the DME cohort.

In terms of safety, the incidence of serious ocular TEAEs was low in both groups with a 1% pooled IOI rate. Overall, we felt that the safety profile of monthly aflibercept eight milligram was consistent with the previously established safety profile we've seen with aflibercept two and eight milligram in previous clinical trials. So I think this data really supports the recent label change to aflibercept eight milligram to be dosed up to every four weeks. But what I found most interesting was the anatomic and functional improvements that we saw in this previously treated patient population. Prior to the study, about 40% of these patients were receiving monthly injections in the six months prior to study entry and their baseline best corrected visual acuity was 20 / 40. So this was a reasonably well-managed patient population, yet we still saw these improvements. I think this suggests there is benefit to aggressive aflibercept eight milligram monthly dosing and certainly I think that having greater flexibility could lead to better patient outcomes, particularly in certain subsets of patients.