FDA Approves EYLEA® (aflibercept) Injection for Diabetic Retinopathy

  • EYLEA improves diabetic retinopathy and prevents worsening disease that can lead to blindness
  • Diabetic retinopathy is the leading cause of blindness among working-aged American adults

TARRYTOWN, NY, USA I May 13, 2019 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness.

"Millions of people have been robbed of their vision due to the progression of diabetic retinopathy," said David Brown, M.D., F.A.C.S., an investigator for the PANORAMA trial and Director of Research at Retina Consultants of Houston. "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."

Approximately eight million people live with DR, a complication of diabetes characterized by damage to the blood vessels in the retina. The disease generally starts as non-proliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. Over time, NPDR often progresses to proliferative diabetic retinopathy (PDR), a stage in which abnormal blood vessels grow on the surface of the retina and into the vitreous cavity, potentially causing severe vision loss.

"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," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "In fact, 80% of patients who received the EYLEA eight-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 eight weeks following five initial monthly injections, or every four weeks.

About the PANORAMA trial
The FDA approval of EYLEA as a treatment for DR was based on six-month and one-year results from PANORAMA, a randomized, multi-center, 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.

About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes eight pivotal Phase 3 trials.

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

SOURCE: Regeneron Pharmaceuticals

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