NPDR Drug Trial Shows Positive Results
The trial aimed to determine whether early intervention with Regeneron Pharmaceuticals' aflibercept injection (Eyelea) improved diabetic retinopathy severity and prevented serious vision-threatening complications.
Positive 1 year results from the Phase 3 PANORAMA trial evaluating Regeneron Pharmaceuticals' aflibercept injection (Eyelea) in patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR) have been announced by Regeneron Pharmaceuticals. These results were presented at the recent Angiogenesis, Exudation, and Degeneration 2019 symposium in Miami.1
The trial confirmed that moderately severe to severe NPDR is not a benign condition, but in fact leaves patients with a high risk of rapidly progressing to vision-threatening events. In untreated patients with severe NPDR, 53% developed these conditions within approximately 1 year, whereas aflibercept treatment prevented approximately 74% of these complications, according to Regeneron. No new adverse effects were reported.1
The trial is an ongoing, pivotal, double-masked, randomized, 2-year trial that enrolled 402 patients in order to investigate aflibercept in individuals with moderately severe to severe NPDR in patients without DME compared to sham injections. The study consisted of the following components:1
- Three treatment arms—An observational sham injection group and 2 aflibercept treatment groups. The drug was dosed every 8 weeks or every 16 weeks.
- Primary endpoint—Defined as the number of patients who experienced a 2-step or greater improvement in the DRSS, a systematic grading scale to assess the severity of diabetic retinopathy based on photographs of the retina following a dilated eye exam, from baseline for the combined aflibercept treatment groups at week 24, and for each aflibercept treatment group separately (every 8-week group and every 16-week group) at week 52.
- Secondary endpoints—These include assessment of whether aflibercept reduced VTCs or development of CI-DME, as well as its impact on other anatomic effects, visual acuity improvement, and safety.
According to the American Academy of Ophthalmology, diabetic retinopathy affects approximately 8 million people and occurs when high blood sugar levels cause damage to blood vessels in the retina, which either swell and leak or close, stopping blood from passing through. This causes blurriness and loss of vision. In the United States, approximately 1.5 million adults are diagnosed with DME, while approximately 3.5 million people have DR without DME.2
The safety and efficacy of aflibercept in diabetic retinopathy in patients without DME have not been fully evaluated by any regulatory authority.1
- One-Year Results from Positive Phase 3 EYLEA Trial in Diabetic Retinopathy Presented at Angiogenesis Symposium. PRNewswire. https://investor.regeneron.com/news-releases/news-release-details/one-year-results-positive-phase-3-eylea-trial-diabetic. Published Feb. 9, 2019. Accessed Feb. 13, 2019.
- What is Diabetic Retinopathy? Kierstan Boyd. American Academy of Ophthalmology. https://www.aao.org/eye-health/diseases/what-is-diabetic-retinopathy. Published December 04, 2018. Accessed Feb. 13, 2019.