Eyeworld

EW NEWS & OPINION 26 and prepared an aqueous solution of HA. Fabrication of the ilomastat tablet using linear HA (Healon GV, Abbott Medical Optics, Santa Ana, Calif.) resulted in a sustained release of ilomastat over 11 days with a total ilomastat release of 83.2±1.8% (maximum ilomastat concentration of 246.5±32.3 μm at tmax of 31.0±18.0 h). The release of ilomastat was more prolonged when crosslinked HA (Healaflow, Anteis, Geneva, Switzerland) was used, they said. Ranibizumab shows promise in DME In the RIDE/RISE studies (evaluating ranibizumab for the treatment of diabetic macular edema [DME]), after a crossover period beginning at month 24, the original sham group never caught up to those who had always been treated with antivascu- lar endothelial growth factor (VEGF) ranibizumab, said Allen Ho, MD, Wills Eye Hospital, Philadelphia. During open-label extension with an average additional 14 months' fol- low-up, an annualized 3.8 injections per year were needed. The safety profile was consistent with similar SAEs reported in the two core stud- ies, and about 25% of patients did not need further injections during the open-label extension. In RIDE/ RISE, initial arms gained 12.4 letters (0.3 mg) and 11.2 letters (0.5 mg), but the crossover arm only gained 4.5 letters at month 36. By month 54, there was no discernable change in letter gain/loss from month 36; central foveal thickness (CFT) changes were generally maintained with PRN treatment as well. In- creased IOP was the main ocular adverse event, affecting about 3% of all patients (n=500) during the open label extension, Dr. Ho said, adding no endophthalmitis was observed. Aflibercept 2q4 best in treatment-naive DME patients VIVID/VISTA-DME are two similarly designed phase 3 studies randomiz- ing 872 patients with DME to receive either aflibercept 2 mg every 4 weeks (2q4), aflibercept 2 mg every 8 weeks (2q8, following 5 initial monthly doses), or laser. An ex- ploratory analysis examined the im- provements in best corrected visual acuity and central retinal thickness (CRT) at week 52 in patients with and without prior anti-VEGF therapy, which could include bevacizumab, ranibizumab, or pegaptanib, said Quan Dong Nguyen, MD, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Neb. If patients had previously undergone anti-VEGF therapy, there was a 2- month washout and prior steroid therapy involved a 3-month washout, he said. "Aflibercept 2q4 seemed to do the best in the anti-VEGF naive component," he said. "About 50% of the patients gained 15 or more letters. Any other treatment was about 30%." Dr. Nguyen recommends indi- vidualized treatment for DME pa- tients, as these results found some respond better to monthly treat- ment. "Don't slow treatment down if the patient is continuing to show improvement," he said. "Once they're no longer showing improvement, consider moving them to a PRN or treat-and-extend regimen." EW Editors' note: Dr. Ho has financial interests with Genentech (South San Francisco), Regeneron (Tarrytown, N.Y.), and Allergan (Irvine, Calif.). Dr. Nyugen has financial interests with Bausch + Lomb (Bridgewater, N.J.), Genentech, and Regeneron. Ms. Van de Pol is an employee of AcuFocus (Irvine, Calif.). The others physicians have no financial interests related to their presentations. July 2014 Highlights continued from page 24 12-29 News_EW July 2014-DL_Layout 1 6/27/14 7:59 AM Page 26

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