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VEGF Trap decreases retinal thickness, meets study endpoint in phase 1 trial
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FORT LAUDERDALE, Fla. — VEGF Trap, an drug in development by Regeneron, produced a statistically significant decrease in retinal thickness in patients with wet age-related macular degeneration in a phase 1 study presented here.
“VEGF Trap successfully met its pre-specified efficacy endpoint in patients with advanced wet AMD,” company officials announced in a press release during the meeting of the Association for Research in Vision and Ophthalmology.
The drug blocks “both the long and short forms” of vascular endothelial growth factor, according to the company.
In a clinical study, Quan dong Nguyen, MD, and colleagues at the Wilmer Eye Center randomized 25 patients with neovascularization to receive either placebo or systemic delivery of the VEGF Trap at doses of 0.3 mg/kg, 1 mg/kg or 3 mg/kg. At follow-up visits, outcomes showed a significant decrease in excess retinal thickness, with a greater effect in magnitude and duration with the higher drug doses.
“Results also indicated that the VEGF Trap caused a dose-dependant increase in blood-pressure. Hypertension appears to be a ‘class-effect’ of systemically administered anti-VEGF agents,” the press release said.
Regeneron plans to begin a phase 1 study for the VEGF Trap in mid-2005 in advanced wet AMD patients using direct injections into the eye, according to the release.