Regeneron (REGN) Announces EYLEA Phase 2 CAPELLA Missed Primary Endpoint in Neovascular Age-Related Macular Degeneration
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Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced topline results from the Phase 2 CAPELLA study evaluating aflibercept co-formulated with rinucumab, an anti-platelet-derived growth factor receptor beta (anti-PDGFR-beta) antibody, in patients with neovascular age-related macular degeneration (wet AMD). The combination therapy did not demonstrate an improvement in best corrected visual acuity (BCVA) compared to intravitreal aflibercept injection monotherapy at 12 weeks, the primary endpoint of the study. At 12 weeks, patients in both combination aflibercept/rinucumab groups showed a 5.8 letter improvement in BCVA. Patients treated with aflibercept alone showed a 7.5 letter improvement in BCVA.
"EYLEA® (aflibercept) injection is an established, effective therapy that has set a high bar in the treatment of wet AMD," said George D. Yancopoulos M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "The addition of rinucumab did not improve on the efficacy of aflibercept alone. We are committed to continuing to innovate for patients with serious vision-threatening diseases, and look forward to the results of our ongoing combination studies of aflibercept and nesvacumab, an anti-angiopoietin 2 antibody, for which the preclinical data is more supportive."
EYLEA results in this study were consistent with the efficacy and safety seen in Phase 3 pivotal studies in wet AMD. The efficacy results in the CAPELLA trial were consistent across all choroidal neovascularization (CNV) subtypes. Adding rinucumab to aflibercept showed no benefit on anatomic endpoints including reduction in retinal thickness or in resolution of subretinal hyper-reflective material. Ocular adverse events at 12 weeks were more common in the combination treatment groups (23.5 and 20 percent) compared to aflibercept alone (16 percent), primarily driven by an increase in conjunctival hemorrhage, eye irritation and eye pain.
The ongoing Phase 2, double-masked, randomized, controlled, multiple-dose, regimen-ranging study has enrolled approximately 500 patients with wet AMD. Efficacy was evaluated using the Early Treatment Diabetic Retinopathy Scale (ETDRS) BCVA. Patients were randomized into one of three groups and received fixed doses every four weeks of either aflibercept monotherapy 2mg, aflibercept 2mg/rinucumab 1mg or aflibercept 2mg/rinucumab 3mg. The co-formulation was administered as a single intravitreal injection. At week 12, two of the three treatment groups were re-randomized, resulting in five total dosing groups in the second phase of the study. Data will be evaluated at 28 weeks and again at 52 weeks, when the study is completed.
More detailed results will be submitted for presentation at a future medical congress.
IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
EYLEA® (aflibercept) Injection is a prescription medication administered by injection into the eye. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.
Injection into the eye with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye). Inflammation in the eye has been reported with the use of EYLEA.
In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.
There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.
Serious side effects related to the injection procedure with EYLEA are rare but can occur including infection inside the eye and retinal detachment.
The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment. It is important that you contact your doctor right away if you think you might be experiencing any side effects.
EYLEA is for prescription use only. For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA.
Please see the full U.S. Prescribing Information for EYLEA at www.EYLEA.com. The product information is intended only for residents of the United States. The product discussed herein may have different labeling in different countries.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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