05.13.19

FDA Approves Eylea for All Stages of Diabetic Retinopathy

Source: Regeneron

Regeneron announced that the FDA has approved Eylea (aflibercept) injection to treat all stages of diabetic retinopathy (DR). The FDA approval of Eylea as a treatment for DR was based on 6-month and 1-year results from PANORAMA, a randomized, multicenter, controlled phase 3 trial that enrolled 402 patients and was designed to investigate Eylea for the improvement of moderately severe to severe NPDR without diabetic macular edema (DME), compared to sham injection. PANORAMA is the first prospective trial to study whether an anti-VEGF can also help prevent worsening disease in patients with NPDR without DME.

Details on trial design included:

  • Three treatment arms – An observational sham injection group and two Eylea treatment groups. Eylea was dosed every eight weeks (following five initial monthly doses) or every 16 weeks (following three initial monthly doses and one eight-week interval).
  • Primary endpoint – The primary endpoint was the proportion of patients who experienced a two-step or greater improvement in the diabetic retinopathy severity scale (DRSS) from baseline for the combined Eylea treatment groups at week 24, and for each Eylea treatment group separately (every eight-week group and every 16-week group) at week 52. The DRSS is a systematic grading scale to assess DR severity based on photographs of the retina.
  • Secondary endpoints – These included assessment of whether Eylea reduced the risk of worsening disease – specifically progression to PDR (including anterior segment neovascularization [ASNV]) or the development of center-involved DME – as well as change in visual acuity.

Key one-year results included:

 

EYLEA

Every 16-Week Regimen

(N=135)

EYLEA

Every 8-Week Regimen

(N=134)

Sham

Control

(N=133)

Primary Endpoint

Patients with ≥2‑step improvement on DRSS score from baseline

65%

80%

15%

Composite Endpoint of Developing PDR or ASNVa

Event Rateb

4%d

2%d

20%d

Hazard Ratio

0.15

0.12

 

Development of PDRc

Event Rateb

2%d

0%d

12%d

Hazard Ratio

0.11

0.00

 

a As diagnosed by either the Reading Center or Investigator through week 52

b Estimated using Kaplan-Meier method

c Defined as ≥2-step worsening on the ETDRS-DRSS score through week 52

d p<0.01 compared with Control

Safety data observed in 269 patients with NPDR through the first year were consistent with those seen in the phase 3 VIVID and VISTA trials.

“Millions of people have been robbed of their vision due to the progression of diabetic retinopathy,” David Brown, MD, FACS, an investigator for the PANORAMA trial and Director of Research at Retina Consultants of Houston, said in a company news release. “The prevention of worsening diabetic retinopathy with Eylea provides a compelling rationale for early treatment of patients with this disease, particularly since eyes dosed with Eylea as infrequently as every 16 weeks showed significant improvements in the pivotal PANORAMA trial.”

“With today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases. The PANORAMA trial showed that by one year 20% of untreated patients developed proliferative diabetic eye disease, and Eylea reduced this risk by 85% to 88% when administered using an every 16-week or eight-week dosing regimen, respectively,” George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron, said in the news release. “In fact, 80% of patients who received the Eylea 8-week dosing regimen had significant improvement in their diabetic retinopathy.”

Eylea is the only vascular endothelial growth factor (VEGF) inhibitor approved with two dosing options for DR, allowing doctors to customize treatment to their patients’ needs. In DR, Eylea may be dosed every 8 weeks following five initial monthly injections, or every 4 weeks.

 

 

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