02.11.19

One-Year Results from Phase 3 Eylea Trial in Diabetic Retinopathy Presented

Source: Regeneron Pharmaceuticals

Regeneron Pharmaceuticals announced that positive detailed 1-year results from the phase 3 PANORAMA trial evaluating Eylea (aflibercept) injection in patients with moderately severe to severe nonproliferative 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 1-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 1-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,” Charles C. Wykoff, MD, PhD, PANORAMA investigator, retina surgeon and ophthalmologist with Retina Consultants of Houston, said in a company news release. “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 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.

 

 

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