The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for aflibercept (Eylea®) injection for an every 16-week dosing regimen in patients with diabetic retinopathy.
In May 2019, the FDA approved Eylea for the treatment of adults with diabetic retinopathy. The dosing regimen is currently 2mg by intravitreal injection every 4 weeks for the first 5 injections followed by 2mg every 8 weeks thereafter.
The sBLA includes 2-year data from the phase 3 PANORAMA trial (ClinicalTrials.gov Identifier: NCT02718326), which compared the efficacy and safety of 2 dosing regimens of aflibercept to sham, in patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). Patients were randomly assigned to receive an intravitreal injection of aflibercept every 8 weeks, every 16 weeks, or sham.
Results showed that at 1 year, the trial met its primary endpoint of proportion of patients with at least a 2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score (80% for the 8-week group vs 65% for the 16-week group; P<.0001). At 2 years, a greater proportion of patients receiving aflibercept every 16-weeks experienced at least a 2-step improvement in DRSS score (50% for the 8-week group vs 62% for the 16-week group; P <.0001). Compared with sham, aflibercept treatment was found to reduce the likelihood of vision-threatening events by at least 75% (P <.0001).
The sBLA also included data from the National Institutes of Health-sponsored Protocol W trial (ClinicalTrials.gov Identifier: NCT02634333), which compared the aflibercept 16-week dosing regimen to sham in patients with moderate to severe NPDR without DME. Findings showed that 45% of patients treated with aflibercept experienced at least a 2-step improvement in DRSS score compared with 14% of the sham group (adjusted odds ratio, 5.91; P <.001). Treatment with aflibercept also reduced the likelihood of developing vision-threatening complications by 68% (P <.001).
Adverse events in these trials were consistent with the known profile of aflibercept.
The FDA is expected to make a decision on the sBLA on February 28, 2023.
Eylea is also approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and DME.
- Eylea® (aflibercept) injection sBLA for every 16-week dosing regimen in patients with diabetic retinopathy accepted for FDA review. News release. Regeneron Pharmaceuticals, Inc. Accessed June 29, 2022. https://www.prnewswire.com/news-releases/eylea-aflibercept-injection-sbla-for-every-16-week-dosing-regimen-in-patients-with-diabetic-retinopathy-accepted-for-fda-review-301577424.html
- Eylea® (aflibercept) injection reduced risk of developing vision-threatening events by 75% after two years in patients with diabetic retinopathy. News release. Regeneron Pharmaceuticals, Inc. February 8, 2020. Accessed June 29, 2022. https://investor.regeneron.com/news-releases/news-release-details/eylear-aflibercept-injection-reduced-risk-developing-vision
- NIH-sponsored trial finds Eylea® (aflibercept) injection reduced vision-threatening complications by 68% after two years in diabetic retinopathy patients. News release. Regeneron Pharmaceuticals, Inc. March 30, 2021. Accessed June 29, 2022. https://investor.regeneron.com/news-releases/news-release-details/nih-sponsored-trial-finds-eylear-aflibercept-injection-reduced