EYLEA® (aflibercept) Injection Improves Diabetic Retinopathy and Reduces Vision-Threatening Complications in Phase 3 Trial
First trial in non-proliferative diabetic retinopathy to show both a reduction in vision-threatening complications and in development of diabetic macular edema
Both every 8-week and every 16-week dosing groups met primary and key secondary endpoints at one year
EYLEA supplemental application for treatment of diabetic retinopathy, based on previously announced 24-week results, currently under
Regeneron also provides update on EYLEA pre-filled syringe regulatory submission
- The development of VTCs (proliferative diabetic retinopathy and anterior segment neovascularization) was 3% for the EYLEA every 8-week group, 4% for the EYLEA every 16-week group, and 20% for the sham injection group (p<0.001).
- CI-DME occurred in 8% of the EYLEA every 8-week group, 7% of the EYLEA every 16-week group, and 26% of the sham injection group (p<0.001).
- These events collectively occurred in 11% and 10% of patients receiving EYLEA every 8 weeks or every 16 weeks, respectively, compared to 41% of patients receiving sham injection (p<0.001).
"Blindness caused by diabetes is one of the most feared consequences of this disease," said
The average number of injections in the first year was 8.6 (of 9 planned) for the EYLEA every 8-week group and 5.5 (of 6 planned) for the EYLEA every 16-week group.
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.
Regulatory Update on EYLEA Pre-filled Syringe
Regeneron also announced today that the
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 diabetic retinopathy severity score (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 (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.
One-year results from PANORAMA will be submitted for presentation at a future medical congress. Six-month PANORAMA results were previously reported in
The safety and efficacy of EYLEA in diabetic retinopathy in patients without diabetic macular edema (DME) have not been fully evaluated by any regulatory authority.
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 PDR, a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and potentially cause 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
IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
- EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
- Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.
- Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
- There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.
- Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment.
- The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
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.
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