Wednesday, April 3, 2024

Smith & Wollensky - Miami Beach
1 Washington Avenue
Miami Beach, FL 33139

Registration: 6:30 PM ET

Event Start Time: 7:00 PM ET

Speaker

Andrew M. Schimel, MD
Center for Excellence in Eye Care
Miami, FL

Overview

An interactive look at PULSAR and PHOTON, the pivotal clinical trials supporting the FDA approval of EYLEA HD. Content will also cover patient cases where EYLEA HD was considered as a treatment option.

To cancel your registration, please email us at ReviewMeetings@MedscapeLIVE.com

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EYLEA HD 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 HD.

WARNINGS AND PRECAUTIONS

Intravitreal injections, including those with aflibercept, 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 HD. 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 HD. 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 HD. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in the wet AMD study (PULSAR) from baseline through week 48 was 0.4% (3 out of 673) in the combined group of patients treated with EYLEA HD compared with 1.5% (5 out of 336) in patients treated with EYLEA 2 mg. The incidence in the DME study (PHOTON) from baseline to week 48 was 3.1% (15 out of 491) in the combined group of patients treated with EYLEA HD compared with 3.6% (6 out of 167) in patients treated with EYLEA 2 mg.

ADVERSE REACTIONS

The most common adverse reactions (≥3%) reported in patients receiving EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA HD and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

INDICATIONS

EYLEA^® HD (aflibercept) Injection 8 mg is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

Please click here for full Prescribing Information for EYLEA HD.

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.

DME = Diabetic Macular Edema, DR = Diabetic Retinopathy, FDA = Food and Drug Administration, Wet AMD = Wet Age-related Macular Degeneration

Open to US Ophthalmologists and Retina Specialists.

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Note, we are unable to provide meals in connection with this presentation to Non-U.S. Healthcare Professionals or Healthcare Professionals holding an active license in Massachusetts, Minnesota or Vermont. If you are a Federal Employee, it is your responsibility to ensure your institution allows you to partake in a meal in connection with this presentation. In addition, spouses and other guests are not permitted to attend unless they would qualify as an appropriate attendee on their own.

EYLEA HD for Wet AMD, DME, and DR