ILUVIEN® FACT SHEET

ABOUT ILUVIEN:                           

Iluvien, which has the potential to be the first FDA-approved prescription product for DME, is a sustained release intravitreal insert. 

• Iluvien is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics.
• The proprietary inserter employs a 25-gauge needle, which allows for a self-sealing wound. 
• Alimera submitted the Iluvien New Drug Application (NDA) to the FDA in June 2010, was granted Priority Review in August and has a PDUFA date of December 30, 2010.
• The Iluvien NDA submission was supported by 24-month low-dose data from the Phase 3 pivotal clinical trials (collectively known as the FAME™ Study) for Iluvien.
• Each Iluvien insert is designed to provide a therapeutic effect for up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FA).

Diabetic Macular Edema (DME), the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision.

DME FACTS & FIGURES:

• Approximately 19 percent of diabetes patient studied over a 10-year period were diagnosed with DME.¹
• At least 171 million people worldwide have diabetes; this figure is likely to more than double by 2030.²
• Alimera estimates an incidence of approximately 340,000 cases of DME annually in the U.S.³
• Left untreated, 25 percent of people with DME will develop moderate vision loss within three years.⁴

Alimera conducted two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien for the treatment of DME.

• The FAME study involved 956 patients in sites across the United States, Canada, Europe and India
• The trials tested the efficacy and safety of two doses of Iluvien, a high and low dose.
• The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved.
  • At month 24, 31 percent of the low dose patients (p value of 0.003) had improved vision of 15 letters or more.
  • At month 30, with a sample size of 123 observed patients, an improvement in visual acuity of 15 letters or more was seen in 40 percent of the patients (p value of 0.002).
• The 36-month data will be released in the near future.

• Iluvien consists of a tiny polyimide tube with membrane caps filled with 190/-µg of FA in a polyvinyl alcohol matrix.
  • Iluvien is non-bioerodable; however, both polyimide and the polyvinyl alcohol matrix are biocompatible with ocular tissues and have histories of safe use within the eye.
• A proprietary inserter for Iluvien features an ergonomic design and transparent window to visually confirm Iluvien's presence in the eye. 
  • The Iluvien inserter contains markings to guide retinal specialists to the proper insertion point.
  • The Iluvien inserter uses a 25-gauge needle, which results in a wound that is small enough to seal itself after Iluvien has been inserted into the back of the eye and the needle has been removed. 
  • In the U.S., this procedure is non-surgical and is performed in the retinal specialist's office.

• First Quarter 2005: Licensed technology
• First Quarter 2006: Began Phase III enrollment
• Fourth Quarter 2007: Completed Phase III enrollment
• Fourth Quarter 2009: Phase III 24-Month read-out
• June 2010: Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)

§ Requested and was granted priority review, which could result in an action letter from the FDA in December, 2010.

§ The 24-month low dose clinical trial data was submitted for FDA approval.

• July 2010: Submitted a Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK)

§ Presented through the Decentralized Procedure with the UK MHRA as the Reference Member State (RMS).

§ Submitted applications to additional Concerned Member States (CMS) in the European Union: Austria, France, Germany, Italy, Portugal and Spain 

FOR MORE INFORMATION, PLEASE CONTACT

FLEISHMAN-HILLARD ATLANTA

KERI TOMSIC (404) 739-0111