New PANORAMA phase 3 trial results add to the anti-VEGF's profile for treatment of diabetic retinopathy.
New one-year results from the phase 3 PANORAMA trial assessing aflibercept injection (EYLEA) in patients with severe non-proliferative diabetic retinopathy (NPDR) showed the anti-vascular endothelial growth factor (anti-VEGF) therapy is capable in treating the vision-threatening complications from the disease.
The new data, presented at the Angiogenesis, Exudation, and Degeneration 2019 symposium this weekend, showed aflibercept prevented approximately 74% of the complications associated with NPDR—which affected the vision of 53% of untreated patients in just 1 year, investigators added.
Patients were randomized 1:1:1 to receive either aflibercept once every 8 weeks (n= 134), once every 16 weeks (n= 135), or sham control therapy (n= 133). Investigators assessed for a primary endpoint of percentage of patients with at least two-step improvement on Diabetic Retinopathy Severity Scale (DRSS) score from baseline. The team also assessed for an improvement on rate of vision-threatening events.
Study results showed that 65% and 80% of patients treated with 16-week or 8-week aflibercept, respectively, improved DRSS score by at least 2 steps at 52 weeks from baseline, compared to just 15% of patients on control (P < .0001).
Just 10% and 11% of patients in the treatment arms, respectively, developed a vision-threatening event, compared to 41% of control patients (P < .0001). The trial results present “high-quality data,” PANORAMA investigator and Retina Consultants of Houston retina surgeon and ophthalmologist Charles C. Wykoff, MD, PhD, said. It is the first prospective trial involving patients with NPDR and not diabetic macular edema (DME) since the landmark Early Treatment Diabetic Retinopathy Study (ETDRS) of the 1980s.
“EYLEA treatment reduced the risk of these events by approximately 74% compared to sham injection, underscoring the potential importance of early EYLEA anti-VEGF therapy,” Wykoff said in a statement. “This efficacy was seen even with an every 16-week treatment regimen after loading doses, a management approach that may realistically be achieved in the real world."
Treatment adverse events (AEs) were consistent with aflibercept’s clinical profile, with just 1 treated patient reporting serious treatment-emergent AEs, and another reporting ocular inflammation.
The new complements topline one-year PANORAMA results previously reported at the American Academy of Ophthalmology 2018 Meeting in Chicago, IL, last October. At the time, David Brown, MD, director of research at the Retina Consultants of Houston, told MD Magazine® in an interview that while the needs of patients with debilitating vision-affecting diseases such as NPDR, DME, and age-related macular degeneration (AMD) are being met by anti-VEGFs, sustained-release devices are the next clinical pursuit.
“Hopefully one of these days we'll have something better than a shot every couple of months, but that's for researchers like myself and the guys in the labs to keep working on,” Brown said.
The PANORAMA trial results will support Regeneron Pharmaceuticals’ supplemental Biologics License Applications (sBLA) for aflibercept as a treatment for DR, the leading cause of blindness in patients with diabetes. The sBLA has a decision date of May 13, as set by the US Food and Drug Administration.