FDA APPROVES EYLEA (AFLIBERCEPT) INJECTION FOR DIABETIC RETINOPATHY
?May 13, 2019 -
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.
IMPORTANT?SAFETY?INFORMATION?FOR?EYLEA??(aflibercept)?INJECTION
- 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
- 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.
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 |
- 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.
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months).
- Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months).
- Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months).
- Although not as effective as the recommended every 8 week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly).