Eylea Gains Approval for Treatment of Diabetic Macular Edema
July 29, 2014 – Eylea (aflibercept) received FDA approval to be used for the treatment of Diabetic Macular Edema (DME).
DME is a condition the results from damage to the blood vessels in the eyes and fluids that leak into the macula (part of the retina) which causes a swelling of the eyes. Eylea helps reduce swelling by limiting the formation of new blood vessels and helps keep fluid from leaking out of existing blood vessels.
Eylea was previsously apporoved and is used for the treatment of neovascular age-related macular degeneration and macular edema following central retinal vein occlusion.
Eylea is an injectable medication that is administered into the eye by a specialty trained doctor in a sterile office or clinic. Administration starts with one injection a month for 5 months, followed by one injection every two months.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.