One-Year Results from Positive Phase 3 EYLEA Trial in Diabetic Retinopathy Presented at Angiogenesis Symposium

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

TARRYTOWN, NY, USA I February 9, 2019 I 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 Scale
a p<0.0001 versus sham
b 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 sham
d Nominal p<0.0001 versus sham

Topline one-year results from PANORAMA were previously reported in October 2018.

"PANORAMA provides high-quality data to inform treatment of NPDR without DME, as it is the first prospective trial involving these high-risk patients since the landmark ETDRS trial of the 1980s when laser was the only treatment option," said Charles C. Wykoff, M.D., Ph.D., PANORAMA investigator, retina surgeon and ophthalmologist with Retina Consultants of Houston. "Without treatment, a large percentage of patients in the trial developed proliferative disease and CI-DME in the first year. 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. 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."

Adverse events were consistent with the known profile of EYLEA. Serious ocular treatment-emergent adverse events in the study eye occurred in 0 and 1 patients in the EYLEA treatment groups and 1 patient in the sham injection group. Ocular inflammation occurred in 1 patient in each EYLEA treatment group and 0 patients in the sham injection group. Anti-Platelet Trialists' Collaboration (APTC)-defined arterial thromboembolic treatment-emergent events occurred in 4 and 2 patients in the EYLEA treatment groups and 5 patients in the sham injection group.

A supplemental Biologics License Application (sBLA) for EYLEA in diabetic retinopathy has been accepted for review by the U.S. FDA with a target action date of May 13, 2019.

The safety and efficacy of EYLEA in diabetic retinopathy in patients without DME have not been fully evaluated by any regulatory authority.

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 in patients without DME, compared to sham injections. Details on trial design include:

  • Three treatment arms – An observational sham injection group and two EYLEA treatment groups. EYLEA was dosed every 8 weeks (following five initial monthly doses) or every 16 weeks (following three initial monthly doses and one 8-week interval).
  • Primary endpoint – The primary endpoint was the proportion of patients who experienced a two-step or greater improvement in the DRSS from baseline for the combined EYLEA treatment groups at week 24, and for each EYLEA treatment group separately (every 8-week group and every 16-week group) at week 52. 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.
  • Secondary endpoints – These include assessment of whether EYLEA reduced VTCs (defined as proliferative diabetic retinopathy and anterior segment neovascularization) or development of CI-DME, as well as its impact on other anatomic effects, visual acuity improvement, and safety.

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.

About Diabetic Retinopathy (DR)
Approximately eight million people live with DR, a disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as NPDR and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and into the vitreous cavity potentially causing severe vision loss.

DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 3.5 million people have DR without DME.

About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a vascular endothelial growth factor (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 seven pivotal Phase 3 trials.

INDICATIONS
EYLEA® (aflibercept) Injection is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in patients with DME.

Please visit www.EYLEA.us to see the full Prescribing Information for EYLEA.

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, heart disease, allergic and inflammatory diseases, pain, cancer, 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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