Trial showed that early intervention with EYLEA improved diabetic retinopathy severity and prevented serious vision-threatening complications
EYLEA diabetic retinopathy sBLA target action date of May 13, 2019
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that positive detailed one-year results from the Phase 3 PANORAMA trial evaluating EYLEA® (aflibercept) Injection in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) were presented for the first time at the Angiogenesis, Exudation, and Degeneration 2019 symposium.
The trial confirmed that moderately severe and severe non-proliferative diabetic retinopathy is not a benign condition, with patients at high risk of rapidly progressing to vision-threatening events. In untreated patients with severe NPDR, 53% developed these events at one year. Most importantly, EYLEA treatment prevented approximately 74% of these complications.
Key one-year data presented at the meeting are summarized below:
Sham
Control
(N=133)
|
EYLEA
Every 16 Weeks
(N=135)
|
EYLEA
Every 8 Weeks
(N=134)
| |
Primary Endpoint
| |||
% of patients with ≥2‑step improvement on DRSS score from baselinea
|
15%
|
65%a
|
80%a
|
Impact on Vision-Threatening Events
| |||
Patients who developed a vision-threatening eventb
|
41%
|
10%a
|
11%a
|
Subgroup with severe NPDR at baseline (n=100)
|
53%
|
15%c
|
15%c
|
Subgroup with moderately severe NPDR at baseline (n=302)
|
36%
|
8%d
|
10%d
|
DRSS=Diabetic Retinopathy Severity Scalea p<0.0001 versus shamb Vision-threatening events defined as vision‑threatening complications (VTC; proliferative diabetic retinopathy or anterior segment neovascularization) or central‑involved diabetic macular edema (CI-DME)c Nominal p=0.0019 versus shamd Nominal p<0.0001 versus sham
Topline one-year results from PANORAMA were previously reported in October 2018
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