FDA Approves Eylea injection for the treatment of diabetic macular edema -
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) announced today ' hui that the US Food and Drug administration (FDA) approved Eylea ® (aflibercept) injection for the treatment of diabetic macular edema (DME). The recommended dose of Eylea in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although Eylea may be administered as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when Eylea was administered every 4 weeks compared to every 8 weeks.
"Diabetic macular edema is a leading cause of vision loss in adults of working age in the United States, and we are pleased to offer a new treatment option for these patients," said George D. Yancopoulos, MD, Ph.D., Chief scientific Officer of Regeneron and President of Regeneron Laboratories. "Our clinical studies have shown that treatment with Eylea can help improve and maintain the vision with every eight weeks dosing after 5 doses initial monthly. Eylea is the first VEGF inhibitor approved for dosing on a less than monthly for the treatment of DME. "
approval Eylea in DME was based on one-year data from Phase 3 VISTA-DME and VIVID-DME study of 862 patients, which compared Eylea 2 mg administered per month, Eylea 2mg every two months (after five initial monthly injections), or photocoagulation macular laser (at start and then as needed). in DME studies, after one year, the mean changes in best corrected visual acuity (of BCVA), as measured by the array of early treatment diabetic retinopathy study (ETDRS) for the month and both groups the month of Eylea were statistically significantly improved compared to the control group and were similar to each other. through the two trials, patients in both Eylea dosing groups gained, on average, the ability to read about two more lines on an eye chart compared to almost no change in the control group.
In these tests, Eylea had a similar overall incidence of adverse events (AEs), serious AEs eye, and ocular non-serious AEs in all treatment groups and the control group. Arterial thromboembolic events, as defined by the cooperation of the Anti-Platelet Trialists (nonfatal stroke, nonfatal myocardial infarction, and vascular death) also occurred at similar rates in the treatment groups and the a group of witnesses. The most common side effects of emerging eye treatment (EIT) observed in the VISTA-DME and test VIVID-DME included conjunctival hemorrhage, eye pain, cataracts and floaters. The most common non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment group and the control group.
Eylea is available in one, the strength of 2 mg intravitreal injection for all approved indications. Eylea was approved in the US for the treatment of neovascular (wet) related macular degeneration age (AMD) in 2011, and for the treatment of macular edema following Retinal Vein Occlusion Central (CRVO) in 2012 . Eylea was also approved the EU and other countries for use in wet AMD and macular edema following CRVO. In Europe, the human use of medications Committee gave a positive opinion recommending approval of Eylea for the treatment of DME. Requests have also been made in Japan, Asia Pacific and Latin America for the treatment of diabetic macular edema. In Japan, Eylea was also subject to regulatory approval for the treatment of choroidal neovascularization secondary to pathologic myopia (MCNV). A regulatory submission was made to the US and EU for Eylea for the treatment of macular edema following retinal vein occlusion Directorate (BRVO).
Phase 3 Study details
In phase 3 VISTA-DME and test VIVID-DME, Eylea ® (aflibercept) Injection 2 mg dosed monthly and Eylea 2mg dosed every two months after 5 initial monthly doses achieved statistically significant improvements in the primary endpoint of mean change in BCVA at one and the secondary endpoint of proportion of patients who gained at least 15 letters in BCVA compared departing from control.
in the VISTA-DME trial, patients receiving Eylea 2mg monthly had a mean change from baseline BCVA of 12.5 letters ( P less than 0.01 vs. witness ), patients receiving Eylea 2mg every two months (after 5 initial monthly injections) had a mean change from baseline BCVA of 10.7 letters ( P less than 0, 01 compared to control ), and patients receiving control treatment had a mean change from baseline BCVA of 0.2 letters. In test VISTA-DME, the percentage of patients who gained at least 15 letters of BCVA baseline, or three lines of vision, was 41.6 percent in the Eylea 2mg monthly groups ( P less than 0.01 compared to control ), 31.1 percent in the Eylea 2 mg to each group of 2 months (after 5 initial monthly injections) ( P less than 0.01 by compared to control ) and 7.8 percent in the control group.
in Test VIVID-DME, patients receiving Eylea 2mg monthly had a mean change from baseline BCVA of 10.5 letters ( P less than 0.01 vs. witness ), patients receiving Eylea 2mg every two months (after 5 initial monthly injections) had a mean change from baseline 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 Test VIVID-DME, the percentage of patients who gained at least 15 letters of BCVA baseline, or three lines of vision, was 32.4 percent in the Eylea 2mg monthly groups ( P less than 0.01 compared to control ), 33.3 percent in the Eylea 2 mg to each group of 2 months (after 5 initial monthly injections) ( P less than 0.01 by compared to control ) and 9.1 percent in the control group.
In these tests, Eylea had similar overall incidence of adverse events (AEs), serious AEs eye, and ocular non-serious AEs in all treatment groups and the control group. Arterial thromboembolic events, as defined by the cooperation of the Anti-Platelet Trialists (nonfatal stroke, nonfatal myocardial infarction, and vascular death) also occurred at similar rates in the treatment groups and the a group of witnesses. The most common side effects of emerging eye treatment (EIT) observed in the VISTA-DME and VIVID-DME trial to one year included conjunctival hemorrhage, eye pain, cataracts and floaters. The most common non-ocular TEAEs one year included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment group and the control group.
The VISTA-DME and VIVID-DME study will continue as planned for a total of three years.
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