DME Extended Dosing Trial Results: Injection Reduction With High-Dose Anti-VEGF

"DME Extended Dosing Trial Results: Injection Reduction With High-Dose Anti-VEGF" walks through the PHOTON trial design, its 96-week results, and the cost model built on those data.

Dr. Yannuzzi reviews the PHOTON study, a randomized, double-masked, 96-week non-inferiority phase 2/3 trial of aflibercept 8 mg in DME. Adults with center-involved DME and vision of roughly 20/32 to 20/320 were randomized 1 to 2 to 1. Arms were aflibercept 2 mg every 8 weeks, 8 mg every 12 weeks, or 8 mg every 16 weeks after loading doses.

Visual gains and central subfield thickness improvements of roughly 180 microns were comparable across arms. Of patients on 8 mg every 12 or 16 weeks, about 80% kept their randomized interval. About 40% in the Q12 arm and 47% in the Q16 arm would have qualified for 20-week intervals. Safety was similar, with no significant inflammation and low serious ocular event rates.

He then introduces the model-based cost analysis built on the PHOTON data, which included 658 patients, about half treatment-naive. Mean injections at 96 weeks were 13.8, 9.5, and 7.8. Direct costs used Medicare allowables and drug wholesale acquisition costs, and indirect costs included caregiver time and travel. A 10,000-run Monte Carlo analysis was performed for each arm.

Dr. Patel was impressed that 40% could move to 20-week dosing intervals, since his practice had been thinking in terms of 4 to 16 weeks prior to this data being released. He was surprised that 16-week dosing held vision and thickness as well as the comparators. Dr. Yannuzzi sees the same injection reduction in practice. His best candidates respond well to 2 mg but have not reached optimal extension, and real-world switch data show about two extra weeks of durability.

Our next episode, "DME Cost Analysis: Strengths and Limits of Trial-Based Economic Modeling," asks what a trial-based economic model can and cannot tell clinicians.