Regeneron Pharmaceuticals, Inc. have announced that US FDA has approved EYLEA® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME).
The recommended dosage of EYLEA in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.
EYLEA is the first VEGF inhibitor approved for dosing on a less than monthly basis for the treatment of DME.
The approval of EYLEA in DME was based on the one-year data from the Phase 3 VISTA-DME and VIVID-DME studies of 862 patients, which compared EYLEA 2 mg given monthly, EYLEA 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed).
In the DME studies, after one year, the mean changes in Best Corrected Visual Acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for the monthly and every two month EYLEA groups, were statistically significantly improved compared to the control group and were similar to each other. Across both trials, patients in both EYLEA dosing groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group.
In these trials, EYLEA had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group.
The most frequent ocular treatment emergent AEs (TEAEs) observed in the VISTADME
and VIVID-DME trials included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most common monocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.
EYLEA is available as a single, 2-mg strength intravitreal injection for all approved indications.
DME is the third approved indication for EYLEA in the U.S. It was earlier approved in the US for treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in 2011, and for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012.
EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO. In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for EYLEA in the treatment of DME. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of Diabetic Macular Edema. In Japan, EYLEA has been
additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). A regulatory submission has been made in the U.S. and EU for EYLEA for the treatment of Macular Edema
following Branch Retinal Vein Occlusion (BRVO).
Details of the Phase 3 VISTA-DME and VIVID-DME trials:
In the Phase 3 VISTA-DME and VIVID-DME trials, EYLEA® (aflibercept) Injection 2 mg dosed monthly and EYLEA 2 mg dosed every two months after 5 initial monthly doses achieved statistically significant improvements in the primary endpoint of mean change in BCVA at one year and the secondary endpoint of proportion of patients who gained at least 15 letters in BCVA versus baseline compared to control.
In the VISTA-DME trial, patients receiving EYLEA 2 mg monthly had a mean change from baseline in BCVA of 12.5 letters (P less than 0.01 compared to control), patients receiving EYLEA 2 mg every two months (after 5 initial monthly injections) had a mean change from baseline in BCVA of 10.7 letters (P less than 0.01 compared to control), and patients receiving control treatment had a mean change from baseline in BCVA of 0.2 letters. In the VISTA-DME trial, the percentage of patients who gained at least 15 letters in BCVA from baseline, or three lines of vision, was 41.6 percent in the EYLEA 2 mg every month group (P less than 0.01 compared to control), 31.1 percent in the EYLEA 2 mg every 2 months group (after 5 initial monthly injections) (P less than 0.01 compared to control), and 7.8 percent in the control group.
In the VIVID-DME trial, patients receiving EYLEA 2 mg monthly had a mean change from baseline in BCVA of 10.5 letters (P less than 0.01 compared to control), patients receiving EYLEA 2 mg every two months (after 5 initial monthly injections) had a mean change from baseline in BCVA of 10.7 letters (P less than 0.01 compared to control), and patients receiving control had a mean change from baseline in BCVA of 1.2 letters. In the VIVID DME trial, the percentage of patients who gained at least 15 letters in BCVA from baseline, or three lines of vision, was 32.4 percent in the EYLEA 2 mg every month group (P less than 0.01 compared to control), 33.3 percent in the EYLEA 2 mg every 2 months group (after 5 initial monthly injections) (P less than 0.01 compared to control), and 9.1 percent in the control group.
In these trials, EYLEA had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VISTADME and VIVID-DME trials at one year included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most
common non-ocular TEAEs at one year included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.
The VISTA-DME and VIVID-DME studies will continue as planned for a total of three years.
Source
To read more about Diabetic Macular Edema (DME), click here.
To read more about EYLEA® (aflibercept) Injection, click here.
The recommended dosage of EYLEA in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.
EYLEA is the first VEGF inhibitor approved for dosing on a less than monthly basis for the treatment of DME.
The approval of EYLEA in DME was based on the one-year data from the Phase 3 VISTA-DME and VIVID-DME studies of 862 patients, which compared EYLEA 2 mg given monthly, EYLEA 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed).
In the DME studies, after one year, the mean changes in Best Corrected Visual Acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for the monthly and every two month EYLEA groups, were statistically significantly improved compared to the control group and were similar to each other. Across both trials, patients in both EYLEA dosing groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group.
In these trials, EYLEA had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group.
The most frequent ocular treatment emergent AEs (TEAEs) observed in the VISTADME
and VIVID-DME trials included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most common monocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.
EYLEA is available as a single, 2-mg strength intravitreal injection for all approved indications.
DME is the third approved indication for EYLEA in the U.S. It was earlier approved in the US for treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in 2011, and for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012.
EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO. In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for EYLEA in the treatment of DME. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of Diabetic Macular Edema. In Japan, EYLEA has been
additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). A regulatory submission has been made in the U.S. and EU for EYLEA for the treatment of Macular Edema
following Branch Retinal Vein Occlusion (BRVO).
Details of the Phase 3 VISTA-DME and VIVID-DME trials:
In the Phase 3 VISTA-DME and VIVID-DME trials, EYLEA® (aflibercept) Injection 2 mg dosed monthly and EYLEA 2 mg dosed every two months after 5 initial monthly doses achieved statistically significant improvements in the primary endpoint of mean change in BCVA at one year and the secondary endpoint of proportion of patients who gained at least 15 letters in BCVA versus baseline compared to control.
In the VISTA-DME trial, patients receiving EYLEA 2 mg monthly had a mean change from baseline in BCVA of 12.5 letters (P less than 0.01 compared to control), patients receiving EYLEA 2 mg every two months (after 5 initial monthly injections) had a mean change from baseline in BCVA of 10.7 letters (P less than 0.01 compared to control), and patients receiving control treatment had a mean change from baseline in BCVA of 0.2 letters. In the VISTA-DME trial, the percentage of patients who gained at least 15 letters in BCVA from baseline, or three lines of vision, was 41.6 percent in the EYLEA 2 mg every month group (P less than 0.01 compared to control), 31.1 percent in the EYLEA 2 mg every 2 months group (after 5 initial monthly injections) (P less than 0.01 compared to control), and 7.8 percent in the control group.
In the VIVID-DME trial, patients receiving EYLEA 2 mg monthly had a mean change from baseline in BCVA of 10.5 letters (P less than 0.01 compared to control), patients receiving EYLEA 2 mg every two months (after 5 initial monthly injections) had a mean change from baseline in BCVA of 10.7 letters (P less than 0.01 compared to control), and patients receiving control had a mean change from baseline in BCVA of 1.2 letters. In the VIVID DME trial, the percentage of patients who gained at least 15 letters in BCVA from baseline, or three lines of vision, was 32.4 percent in the EYLEA 2 mg every month group (P less than 0.01 compared to control), 33.3 percent in the EYLEA 2 mg every 2 months group (after 5 initial monthly injections) (P less than 0.01 compared to control), and 9.1 percent in the control group.
In these trials, EYLEA had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VISTADME and VIVID-DME trials at one year included conjunctival hemorrhage, eye pain, cataract, and vitreous floaters. The most
common non-ocular TEAEs at one year included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.
The VISTA-DME and VIVID-DME studies will continue as planned for a total of three years.
Source
To read more about Diabetic Macular Edema (DME), click here.
To read more about EYLEA® (aflibercept) Injection, click here.
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