03.19.18

Eylea Demonstrates Positive Topline Results in Phase 3 Non-Proliferative Diabetic Retinopathy Trial

Source: Eylea

Regeneron Pharmaceuticals announced that the phase 3 PANORAMA trial evaluating Eylea (aflibercept) injection in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) met its 24-week primary endpoint. In the trial, 58 percent of Eylea-treated patients experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale (DRSS) at week 24, compared to 6 percent of patients receiving sham injection (P < 0.0001).

"This is the first time a therapy has demonstrated it can reverse disease progression in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema, in a trial specifically designed to study this population," George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, said in a company news release. "Patients in the trial continue to be evaluated to determine if Eylea can prevent progression to neovascular vision-threatening complications or diabetic macular edema. We look forward to sharing one-year results later this year."

Patients in the active treatment groups received, on average, 4.4 Eylea injections during the first 24 weeks. There were no new safety signals in the trial. There was one case of mild intraocular inflammation (IOI) in a patient treated with Eylea (0.085 percent rate per injection), which is consistent with the rate of IOI seen in previous clinical trials.

About the PANORAMA trial

PANORAMA is an ongoing, pivotal, double-masked, randomized two-year trial that enrolled 402 patients and is designed to investigate Eylea for the improvement of moderately severe to severe NPDR without diabetic macular edema (DME), compared to sham injection. Details on trial design include:

  • Three treatment arms - An observational sham injection group and two Eylea treatment groups. The Eylea treatment groups started with either three or five initial monthly doses, and the trial will evaluate every eight-week dosing or every 16-week dosing at one year.
  • Two primary endpoints - Both assess the proportion of patients who experience a two-step or greater improvement in DRSS score from baseline. The first is measured at six months (24 weeks) and the second at one year (52 weeks). The DRSS is a systematic grading scale to assess the severity of diabetic retinopathy based on photographs of the retina following a dilated eye exam.
  • Key secondary endpoints - These include assessment of whether Eylea prevents neovascular vision-threatening complications (such as progression to proliferative diabetic retinopathy (PDR) and anterior segment neovascularization) or progression to DME, as well as its impact on other anatomic effects, visual acuity improvement, and safety. Some secondary endpoints will be measured for up to two years.

Results from PANORAMA will be submitted for presentation at a future medical congress. PANORAMA will also form the basis of a supplemental Biologics License Application (sBLA) to the FDA later this year.

A separate ongoing trial sponsored by the Diabetic Retinopathy Clinical Research Network known as Protocol W is also evaluating Eylea for the treatment of NPDR in patients without DME.

The safety and efficacy of the potential use of Eylea in moderately severe to severe NPDR in patients without DME have not been fully evaluated by any regulatory authority.

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