Eylea (aflibercept) Injection

For the treatment of wet AMD

A Video Presentation on the Pathophysiology of Wet AMD and the Mechanism of Action of EYLEA® (aflibercept) Injection

EYLEA Clinical Pharmacology and Formulation

About EYLEA About EYLEA

Potential challenges in the treatment of Wet AMD

EYLEA has been specifically developed to reduce the need for monthly monitoring visits and injections1

Warnings and Precautions from the EYLEA Prescribing Information

IMPORTANT PRESCRIBING INFORMATION FOR EYLEA® (aflibercept) INJECTION

EYLEA® (aflibercept) Injection is indicated for the treatment of patients with neovascular (Wet) Age-related Macular Degeneration (AMD). The recommended dose for EYLEA is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.

EYLEA is indicated for the treatment of patients with Macular Edema following Central Retinal Vein Occlusion (CRVO). The recommended dose for EYLEA is 2 mg administered by intravitreal injection every 4 weeks (monthly).

IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION

EYLEA® (aflibercept) Injection 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.

Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA.

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 use of intravitreal VEGF inhibitors, including EYLEA, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of ATEs in the VIEW 1 and VIEW 2 wet AMD studies in patients treated with EYLEA was 1.8% during the first year. The incidence of ATEs in the COPERNICUS and GALILEO CRVO studies was 0% in patients treated with EYLEA compared with 1.4% in patients receiving sham control during the first six months.

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

Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis, traumatic cataract, increased intraocular pressure, and vitreous detachment.

Please see the full Prescribing Information for EYLEA.

The product information in this site 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.

References:

  1. Data on file, Regeneron Pharmaceuticals Inc., FDA Briefing Document, June 17, 2011.
  2. Bressler SB. Introduction: Understanding the role of angiogenesis and antiangiogenic agents in age-related macular degeneration. Ophthalmology. 2009; 116, 10, Supplement: S1-S7.
  3. Papadopoulos N, et al. Angiogenesis. 2012; online Feb. 3. DOI:10.1007/s10456-011-9249-6.
  4. Holash J, Davis S, Papadopoulos N, et al. VEGF-Trap: A VEGF blocker with potent antitumor effects. Proc Natl Acad Sci USA. 2002; 99:11393-8.
  5. Data on file, Regeneron Pharmaceuticals Inc., BLA Sec. 2.3.S, Drug Substance.
  6. Holz FG, Amoaku W, Donate J, et al. Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the SUSTAIN study. Ophthalmology. 2011;118:663-671.
  7. Boyer DS, Heier JS, Brown DM, et al. A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration. Ophthalmology. 2009;116:1731-1739.
  8. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. New Engl J Med. 2006;355:1419-1431.
  9. Brown DM, Kaiser PK, Michels M, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. New Engl J Med. 2006;355:1432-1444.
  10. Brown GC, Brown MM, Brown HC, et al. The comparative effectiveness and cost-effectiveness of intraocular 90Sr brachytherapy/intravitreal VEGF inhibitor for neovascular macular degeneration. Evidence-Based Ophthalmol. 2009;10:107-122.
  11. Data on file: Market Research: Time and Motion Study Final Report: Ethnography and Qualitative Research, June 30, 2011.

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