High-dose aflibercept shows promise in wet AMD treatment
Patients with wet age-related macular degeneration who were treated with high-dose aflibercept experienced improvements in anatomical and vision outcomes through 44 weeks, according to a press release from Regeneron.
CANDELA, a phase 2, randomized, single-masked trial, enrolled 106 patients with wet AMD to study the efficacy, safety and tolerability of aflibercept 8 mg compared with currently approved Eylea (aflibercept 2 mg).
At week 44, 40% of patients who received aflibercept 8 mg had no fluid in the center subfield compared with 28% of patients who received aflibercept 2 mg, which was not a statistically significant difference; 32% who received aflibercept 8 mg had no macular fluid compared with 15% who received aflibercept 2 mg (nominal P = .0395). Patients who received aflibercept 8 mg were more likely to be dry in the center subfield at each timepoint after the initial monthly dosing.
Patients who received aflibercept 8 mg had an average improvement of 7.9 letters from baseline compared with 5.1 letters in patients who received aflibercept 2 mg; the difference was not statistically significant.
“The results of this phase 2 trial for aflibercept 8 mg are promising, and we look forward to seeing the results from the phase 3 program, which we hope will show that aflibercept 8 mg can deliver clinical outcomes that, at a minimum, will be comparable to standard-of-care Eylea but allow for extended dosing regimens,” George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said in the release.
Adverse events occurred at the same rate in the 8 mg and 2 mg groups. There were no serious adverse events involving ocular inflammation and no anti-platelet trialists’ collaboration-defined arterial thromboembolic events. Adverse events that occurred more frequently in the aflibercept 8 mg group compared with the aflibercept 2 mg group included vitreous detachment (four cases vs. two cases), conjunctival hemorrhage (three cases vs. two cases) and retinal tear (two cases vs. zero cases).