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Macular Edema Following Retinal Vein Occlusion: Phase III Clinical Trial Outcomes

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Dive into the data from three clinical trials focusing on a treatment option for patients with macular edema following retinal vein occlusion.

  • Overview

    Please see Important Safety Information and Full Prescribing Information below.

    EYLEA® (aflibercept) Injection 2 mg is an anti-VEGF agent that is FDA-approved for macular edema following retinal vein occlusion (RVO).1 The approval of EYLEA for this indication was based on three robust clinical trials demonstrating the efficacy and safety of EYLEA: VIBRANT, COPERNICUS, and GALILEO.1 Here with Dr. Charles Turck to break down the trials’ designs and key findings is Dr. John Kitchens, Partner, Ophthalmologist, and Vitreoretinal Surgeon at Retina Associates of Kentucky in Lexington, KY. Dr. Kitchens is a paid consultant of Regeneron.

  • INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATION

    EYLEA® (aflibercept) Injection 2 mg is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    • EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

    WARNINGS AND PRECAUTIONS

    • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion. Proper aseptic injection technique must always be used when administering EYLEA. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.

    • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.

    • There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies.

    ADVERSE REACTIONS

    • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment. 

    • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

    • Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

    Please click here for full Prescribing Information for EYLEA.

    Reference:

    1. EYLEA® (aflibercept) Injection full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. December 2023. 

     

Schedule13 Dec 2024