MyVisionTest News Archive
Jan 8, 2012
FDA Approves VEGF-Trap for AMD
The US Food and Drug Administration (FDA) approved aflibercept ophthalmic solution (Eylea, Regeneron Pharmaceuticals Inc) for the treatment of neovascular ("wet") age-related macular degeneration (AMD) in November 2011.
"Eylea is an important new treatment option for adults with wet AMD," said Edward Cox of the FDA. "It is a potentially blinding disease and the availability of new treatment options is important."
The recommended dose is 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months), according to a Regeneron news release.
"We are very excited about the approval of this drug," aflibercept trial investigator David S. Boyer, of the University of Southern California. "We know that with AMD drugs, 1 size does not fit all. Ranibizumab (Lucentis, Genentech) and bevacizumab (Avastin, Genentech) are excellent drugs, but there are patients who do not have an optimal response to them. This drug may offer an incredible ability to dry these patients out and improve their vision."
Aflibercept, an injectable drug, is a highly potent blocker of vascular endothelial growth factor (VEGF) and placental growth factor. VEGF's normal role is to trigger formation of new blood vessels supporting growth of bodily tissues, but in AMD it is also associated with the growth of abnormal new blood vessels in the eye that exhibit vascular permeability and lead to edema.
Philip Rosenfeld, of the Bascom Palmer Eye Institute, commented, "I don't anticipate better visual acuity outcomes compared with Lucentis and Avastin, just fewer visits and fewer injections. If the use of aflibercept can decrease the need for retreatment, then this will be a win-win for patients and clinicians."
Aflibercept, also known as VEGF Trap-Eye, is a fully human fusion protein consisting of portions of VEGF receptors 1 and 2, which binds all forms of VEGF-A, along with the related placental growth factor, which the drug blocks.
Drug Was Noninferior to Standard of Care, Ranibizumab
The drug's approval was based on positive results from the 2 phase 3 VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) trials. Both found the drug noninferior to Lucentis, the FDA-approved agent considered the most potent for the condition. In VIEW 1 (n = 1217), conducted in the United States, and VIEW 2 (n = 1240), conducted in Europe, all regimens of the drug, including 2 mg dosed every 2 months (after 3 loading doses), successfully met the primary endpoint of statistical noninferiority compared with Lucentis.
The proportions of patients who maintained or improved vision over the course of 52 weeks in VIEW 1 were 96%, 95%, and 95% of patients receiving aflibercept 0.5 mg monthly, 2.0 mg monthly, and 2.0 mg every 2 months, respectively. This compared with 94% of patients receiving the standard 0.5-mg monthly dose of Lucentis.
For the secondary endpoint, visual acuity, the new drug was better. Patients receiving 2 mg monthly had a greater mean improvement in visual acuity at week 52, with a gain of 10.9 letters compared with 8.1 letters with Lucentis. All other dose groups were not significantly different from Lucentis with respect to this secondary endpoint.
In VIEW 2, vision was maintained in 96% of all aflibercept dose groups and in 94% of the Lucentis group. All doses were statistically noninferior to Lucentis, and no differences were noted between the drugs in visual acuity gain.
More Options Desirable
George Williams, spokesperson for the American Academy of Ophthalmology, commented: "Ophthalmologists are excited about the potential that the VEGF Trap compound has for the management of neovascular AMD.
He found VIEW 1 and VIEW 2 to be "well conducted, designed, and executed, and to provide very strong data to tell us aflibercept is effective," he said. "The question now is where it fits in the therapeutic landscape."
Dr. Williams added that if comparable efficacy with less-frequent dosing (which kicks in after 3 months) holds up for the long term, "this will obviously be a significant advantage to patients."
Echoing the need for multiple treatment options, Dr. Boyer added: "There are anatomic 'nonresponders' who continue to leak, don't flatten out, and require more frequent injections. In some of these resistant cases, the drug can be beneficial. My hope is that because of the affinity of this drug with VEGF, which is 100 times greater than ranibizumab and 1000 [times] greater than bevacizumab, we can dry out some of these patients. And we hope this translates into improvement of vision in the long run," he said.
Dr. Rosenfeld, who pioneered the use of bevacizumab in AMD, said, "If aflibercept lives up to its clinical trial hype in real-world clinical practice, then I would expect aflibercept to replace Lucentis as the high-cost option, while Avastin will continue to be used as the low-cost option."
Read more...
Medscape
Tags: VEGF Trap, clinical trial, FDA, wet AMD
The US Food and Drug Administration (FDA) approved aflibercept ophthalmic solution (Eylea, Regeneron Pharmaceuticals Inc) for the treatment of neovascular ("wet") age-related macular degeneration (AMD) in November 2011."Eylea is an important new treatment option for adults with wet AMD," said Edward Cox of the FDA. "It is a potentially blinding disease and the availability of new treatment options is important."
"We are very excited about the approval of this drug," aflibercept trial investigator David S. Boyer, of the University of Southern California. "We know that with AMD drugs, 1 size does not fit all. Ranibizumab (Lucentis, Genentech) and bevacizumab (Avastin, Genentech) are excellent drugs, but there are patients who do not have an optimal response to them. This drug may offer an incredible ability to dry these patients out and improve their vision."
Aflibercept, an injectable drug, is a highly potent blocker of vascular endothelial growth factor (VEGF) and placental growth factor. VEGF's normal role is to trigger formation of new blood vessels supporting growth of bodily tissues, but in AMD it is also associated with the growth of abnormal new blood vessels in the eye that exhibit vascular permeability and lead to edema.
Philip Rosenfeld, of the Bascom Palmer Eye Institute, commented, "I don't anticipate better visual acuity outcomes compared with Lucentis and Avastin, just fewer visits and fewer injections. If the use of aflibercept can decrease the need for retreatment, then this will be a win-win for patients and clinicians."
Aflibercept, also known as VEGF Trap-Eye, is a fully human fusion protein consisting of portions of VEGF receptors 1 and 2, which binds all forms of VEGF-A, along with the related placental growth factor, which the drug blocks.
Drug Was Noninferior to Standard of Care, Ranibizumab
The drug's approval was based on positive results from the 2 phase 3 VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) trials. Both found the drug noninferior to Lucentis, the FDA-approved agent considered the most potent for the condition. In VIEW 1 (n = 1217), conducted in the United States, and VIEW 2 (n = 1240), conducted in Europe, all regimens of the drug, including 2 mg dosed every 2 months (after 3 loading doses), successfully met the primary endpoint of statistical noninferiority compared with Lucentis.
The proportions of patients who maintained or improved vision over the course of 52 weeks in VIEW 1 were 96%, 95%, and 95% of patients receiving aflibercept 0.5 mg monthly, 2.0 mg monthly, and 2.0 mg every 2 months, respectively. This compared with 94% of patients receiving the standard 0.5-mg monthly dose of Lucentis.
For the secondary endpoint, visual acuity, the new drug was better. Patients receiving 2 mg monthly had a greater mean improvement in visual acuity at week 52, with a gain of 10.9 letters compared with 8.1 letters with Lucentis. All other dose groups were not significantly different from Lucentis with respect to this secondary endpoint.
In VIEW 2, vision was maintained in 96% of all aflibercept dose groups and in 94% of the Lucentis group. All doses were statistically noninferior to Lucentis, and no differences were noted between the drugs in visual acuity gain.
More Options Desirable
George Williams, spokesperson for the American Academy of Ophthalmology, commented: "Ophthalmologists are excited about the potential that the VEGF Trap compound has for the management of neovascular AMD.
He found VIEW 1 and VIEW 2 to be "well conducted, designed, and executed, and to provide very strong data to tell us aflibercept is effective," he said. "The question now is where it fits in the therapeutic landscape."
Dr. Williams added that if comparable efficacy with less-frequent dosing (which kicks in after 3 months) holds up for the long term, "this will obviously be a significant advantage to patients."
Echoing the need for multiple treatment options, Dr. Boyer added: "There are anatomic 'nonresponders' who continue to leak, don't flatten out, and require more frequent injections. In some of these resistant cases, the drug can be beneficial. My hope is that because of the affinity of this drug with VEGF, which is 100 times greater than ranibizumab and 1000 [times] greater than bevacizumab, we can dry out some of these patients. And we hope this translates into improvement of vision in the long run," he said.
Dr. Rosenfeld, who pioneered the use of bevacizumab in AMD, said, "If aflibercept lives up to its clinical trial hype in real-world clinical practice, then I would expect aflibercept to replace Lucentis as the high-cost option, while Avastin will continue to be used as the low-cost option."
Read more...
Medscape
