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 FDA review with an action date of May 13, 2019
Regeneron also provides update on EYLEA pre-filled syringe regulatory submission
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Phase 3 PANORAMA trial evaluating EYLEA (aflibercept) Injection in patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR) met its one-year (52-week) primary endpoint and key secondary endpoints. On the primary endpoint at one year, 80% and 65% of patients receiving EYLEA on an every 8- and every 16-week interval (after an initial monthly dosing period), respectively, experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale, compared to 15% of patients receiving sham injection (p<0.0001). Regarding the two key secondary endpoints, which achieved statistical significance based on the pre-specified hierarchical analysis, treatment with EYLEA also reduced vision-threatening complications (VTCs) by 82%-85% and the development of center-involved diabetic macular edema (CI-DME) by 68%-74% compared with sham injection.
- 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).
- 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.
- 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.
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SOURCE Regeneron Pharmaceuticals, Inc.