Regeneron Pharmaceuticals, Inc.
REGN today announced positive topline results for EYLEA^®
(aflibercept) Injection from the Phase 3 VIBRANT study in patients with
Macular Edema following Branch Retinal Vein Occlusion (BRVO). In this trial,
53% of patients who received EYLEA 2 milligram (mg) every four weeks gained at
least 15 letters in vision from baseline at week 24, the primary endpoint of
the study, compared to 27% of patients who received laser, a standard-of-care
treatment (p<0.001). Patients who received EYLEA 2 mg every four weeks
achieved a 17.0 letter mean improvement over baseline in best corrected visual
acuity (BCVA) compared to a 6.9 letter mean improvement in patients who
received laser (p<0.0001), a key secondary endpoint. VIBRANT is the first
Phase 3 trial in this indication in which an anti-VEGF agent was directly
compared to an active comparator.
The incidence of serious adverse events (SAE) was 9.9% in the EYLEA group and
9.8% in the laser group. One death and one Anti-Platelet Trialists'
Collaboration (APTC) defined event (non-fatal stroke) occurred during the
trial, both in patients in the laser group. The most common ocular adverse
events in the EYLEA treated patients were conjunctival hemorrhage and eye
pain. There were no cases of intraocular inflammation. There was one ocular
SAE in a patient in the EYLEA group, which was a traumatic cataract.
"These positive data in patients with macular edema following BRVO further
support the efficacy of EYLEA in a broad spectrum of retinal diseases," stated
George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and
President of Regeneron Laboratories. "If approved, we hope to be able to
offer physicians and patients a new treatment option for addressing macular
edema associated with this severe and potentially blinding retinal disorder."
"VIBRANT represents the eighth positive trial from the EYLEA Phase 3 program,
which has enrolled over 3,800 patients from around the world and highlights
our commitment to retinal diseases," said Robert Vitti, M.D., Vice President,
Clinical Sciences, Ophthalmology, Regeneron Pharmaceuticals. "We want to
thank all the investigators and patients involved in this study. We are proud
of the effort consistently put forth by the EYLEA development team."
Detailed results from this study will be presented at an upcoming medical
conference. Regeneron intends to submit a regulatory application for
marketing approval for macular edema following BRVO in the U.S. within the
next several months.
EYLEA was approved in the United States for the treatment of neovascular (wet)
Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema
following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has
also been approved in Europe, Japan, Australia, and in many other countries
for use in wet AMD and in Europe and other countries for Macular Edema
following CRVO.
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