Eylea reduced risk for vision-threatening complications at 2 years
The 2-year results of the phase 3 PANORAMA trial evaluating intervention with aflibercept for patients with moderately severe to severe nonproliferative diabetic retinopathy showed consistent treatment greatly prevented serious vision-threatening complications and improved Diabetic Retinopathy Severity Scale scores.
Charles C. Wykoff, MD, PhD, presented the results at Bascom Palmer Eye Institute’s Angiogenesis, Exudation, and Degeneration 2020 symposium in Miami. The double-masked, randomized trial included patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR) treated with Eylea (aflibercept, Regeneron) every 16 weeks (135 participants) or every 8 weeks (134 participants) or with a sham control (133 participants).
“The 2-year results from the randomized phase 3 PANORAMA study confirm and strengthen the 1-year results: Anti-VEGF dosing with aflibercept significantly reduced the development of PDR and center-involved DME by about 75% compared to sham treatment in these high-risk eyes with moderately severe to severe NPDR without DME,” Wykoff told Healio/OSN.
At 100 weeks, 62.2% of participants treated every 16 weeks experienced a two step or greater improvement from baseline in Diabetic Retinopathy Severity Scale score, a slight decrease from 65.2% of participants at 52 weeks. Fifty percent of participants treated every 8 weeks experienced a two step or greater improvement from baseline, a decrease from 79.9% of participants at 52 weeks. In the sham group, 12.8% experienced a two step or greater improvement at 100 weeks. The differences between the treatment groups and sham group were statistically significant (P < .0001).
Additionally, 50.4% of participants in the sham group developed a vision-threatening complication or center-involved diabetic macular edema compared with 16.3% of participants treated every 16 weeks and 18.7% of participants treated every 8 weeks, a statistically significant difference (P < .001).
“Emphasizing the chronic nature of this disease process and the importance of compliance and long-term care delivery, patients receiving fewer anti-VEGF injections in the second year appeared more likely to develop PDR or DME. This is a potentially blinding disease, and prompt, early intervention can achieve excellent outcomes for many patients,” he said. – by Robert Linnehan
Wykoff CC. A phase 3, double-masked, randomized study of the efficacy and safety of aflibercept in patients with moderately severe to severe NPDR. Presented at: Angiogenesis, Exudation, and Degeneration 2020; Feb. 8, 2020; Miami.
Disclosure: Wykoff reports he is a consultant and researcher for Adverum, Genentech/Roche, Novartis, Regeneron and Regenxbio and a consultant for Bayer and Takeda.