Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Second Phase 3 Study in Central Retinal Vein Occlusion
In GALILEO, the primary endpoint at week 24 was achieved: 60.2 percent of patients receiving monthly VEGF Trap-Eye 2 milligrams (mg) gained at least 15 letters of vision from baseline, compared to 22.1 percent of patients receiving sham injections (p<0.0001). The key secondary endpoint of the study was also met: patients receiving VEGF Trap-Eye 2mg monthly gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (p<0.0001).
"After reporting positive results from the VIEW 1 and VIEW 2 Phase 3 studies for the treatment of the neovascular form of age-related macular degeneration, or wet AMD, we are very pleased to now also have two positive Phase 3 trials with VEGF Trap-Eye in central retinal vein occlusion," said
"With two Phase 3 trials showing impressive improvement in vision relative to control, VEGF Trap-Eye has the potential to provide patients and physicians a new treatment option for central retinal vein occlusion," said
As in the COPERNICUS trial, VEGF Trap-Eye was generally well tolerated in the GALILEO study and the most common adverse events were those typically associated with intravitreal injections or the underlying disease. The incidence of ocular serious adverse events was higher in the sham group compared to the active treatment arm (8.8% vs 2.9%).
Regeneron intends to submit a regulatory application for marketing approval in CRVO in the U.S. in the second half of 2011, and
Detailed results of the GALILEO study will be presented at the
About the Phase 3 CRVO Program
Patients in the COPERNICUS (Controlled Phase 3 Evaluation of Repeated intravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) and the almost identical GALILEO (General Assessment Limiting Infiltration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) studies received six monthly injections of either VEGF Trap-Eye at a dose of 2mg or sham injections.
Patients in both trials were randomized in a 3:2 ratio with 114 patients randomized to receive VEGF Trap-Eye and 73 randomized to the control arm in COPERNICUS and 104 patients randomized to receive VEGF Trap-Eye and 68 randomized to the control arm in GALILEO. At the end of the initial six months, all patients randomized to VEGF Trap-Eye are dosed on a PRN (as needed) basis for another six months. In the COPERNICUS trial, patients randomized to sham injections in the first six months were eligible to cross over to VEGF Trap-Eye PRN dosing in the second six months. During the second six months of the studies, all patients are eligible for rescue laser treatment. Visual acuity is measured as a score based on the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard chart used in research to measure visual acuity.
Phase 3 GALILEO Study Results
In the GALILEO study, 60.2 percent of patients receiving VEGF Trap-Eye 2mg monthly gained at least 15 letters of vision from baseline, compared to 22.1 percent of patients receiving sham injections (p<0.0001), the primary endpoint of the study. Patients receiving VEGF Trap-Eye 2mg monthly gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (p<0.0001), a secondary endpoint.
VEGF Trap-Eye was generally well tolerated and the most common adverse events were those typically associated with intravitreal injections or the underlying disease. Serious ocular adverse events in the VEGF Trap-Eye group were 2.9 percent and were more frequent in the control group (8.8 percent). The most frequently reported adverse events overall in the VEGF Trap-Eye arm were eye pain, conjunctival hemorrhage and elevated intraocular pressure. The most frequently reported adverse events in the control group were macular edema, eye irritation, and reduction of visual acuity. The incidence of non-ocular serious adverse events was generally well-balanced between the treatment arms. The most frequent non-ocular adverse events were headache and nasopharyngitis. There were no deaths in the study.
About Central Retinal Vein Occlusion (CRVO)
Over 100,000 people in
About VEGF Trap-Eye
VEGF Trap-Eye is a fully human fusion protein, consisting of soluble VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
Regeneron submitted a Biologics License Application (BLA) for marketing approval in wet AMD in the U.S. in
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration, central retinal vein occlusion, and diabetic macular edema), and certain cancers. Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron's web site at www.regeneron.com.
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