Industry News

Two-year phase 3 results show sustained visual benefit from aflibercept injection

Subjects who were injected with aflibercept for the treatment of diabetic macular edema showed a sustained improvement from baseline in best corrected visual acuity at week 100 compared with those who received laser photocoagulation, according to a press release from Regeneron.

One hundred fifty-five patients in the randomized phase 3 VISTA-DME trial of Eylea (aflibercept, Regeneron) received 2 mg dosed monthly, 152 patients received 2 mg dosed every 2 months after five initial monthly injections, and 154 patients received laser photocoagulation.

After 2 years, patients who were dosed monthly had a mean change from baseline BCVA of 11.5 letters, while patients who were dosed every 2 months had a mean change from baseline BCVA of 11.1 letters. Mean change from baseline BCVA in the laser photocoagulation group was 0.9 letters, the release said.

“These results are particularly encouraging given that 43% of patients in this study had previously received anti-VEGF therapy,” George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in the release.

Aflibercept was generally well tolerated. Adverse events were typical of those seen in other studies of patients with diabetes who received intravitreal anti-VEGF therapy, with conjunctival hemorrhage, eye pain and vitreous floaters as the most frequent ocular adverse events observed.

Subjects who were injected with aflibercept for the treatment of diabetic macular edema showed a sustained improvement from baseline in best corrected visual acuity at week 100 compared with those who received laser photocoagulation, according to a press release from Regeneron.

One hundred fifty-five patients in the randomized phase 3 VISTA-DME trial of Eylea (aflibercept, Regeneron) received 2 mg dosed monthly, 152 patients received 2 mg dosed every 2 months after five initial monthly injections, and 154 patients received laser photocoagulation.

After 2 years, patients who were dosed monthly had a mean change from baseline BCVA of 11.5 letters, while patients who were dosed every 2 months had a mean change from baseline BCVA of 11.1 letters. Mean change from baseline BCVA in the laser photocoagulation group was 0.9 letters, the release said.

“These results are particularly encouraging given that 43% of patients in this study had previously received anti-VEGF therapy,” George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in the release.

Aflibercept was generally well tolerated. Adverse events were typical of those seen in other studies of patients with diabetes who received intravitreal anti-VEGF therapy, with conjunctival hemorrhage, eye pain and vitreous floaters as the most frequent ocular adverse events observed.