ILUVIEN is designated a Class H product in Italy and, as such, is hospital-administered and fully reimbursed for those patients who have previously undergone cataract surgery.
“Italy is an important market for ILUVIEN as it has Europe's fourth largest diabetes population1 and a medical community that regularly uses corticosteroids to treat eye diseases,” said Dan Myers, Alimera’s chief executive officer. “We look forward to hearing from a growing number of Italian retinal specialists and their patients about the benefits of having a product that treats DME consistently every day due to its continuous microdosing, for up to three years.”
ILUVIEN is distributed throughout Italy, San Marino and Vatican City by Societa Industria Farmaceutica Italiana (SIFI), which also handles all promotion, marketing and commercial activities in those territories for ILUVIEN.
“At SIFI, we have focused on offering therapeutic solutions to serious ocular problems for more than 80 years,” said Fabrizio Chines, executive chairman of SIFI SpA. “As we prepared to launch ILUVIEN in Italy, we found that our physicians were eagerly anticipating its availability as it represents a real innovation in DME treatment. By providing a consistent daily dose with one injection over three years, ILUVIEN has the potential to greatly improve patient convenience and adherence to therapy, which naturally lead to better results.”
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in the E.U. to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant with its continuous microdosing is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months, enabling the physician to treat the disease consistently every day.
About Diabetic Macular Edema (DME)
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 associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported 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. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization, research, and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com.
SIFI is the leading Italian ophthalmic company, focused on eye care since 1935. SIFI designs, manufactures and markets innovative pharmaceutical specialty products, surgical and medical devices. Headquartered in Catania, Sicily, SIFI operates directly in Italy, Romania and Mexico with a staff of over 370 people worldwide. Since June 2015, SIFI is backed by 21 Investimenti, the private equity firm founded by Alessandro Benetton and leader in the Italian mid-market, to support the company's international expansion and portfolio development strategy. For more information, please visit www.sifigroup.com.
Forward Looking Statements
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the potential of ILUVIEN to improve patient convenience and adherence to therapy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, SIFI’s ability to adequately promote, market and support ILUVIEN and the degree to which physicians in Italy will use ILUVIEN to treat their DME patients, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Alimera's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, to be filed in the third quarter of 2017 with the SEC. In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
1 International Diabetes Federation. IDF Diabetes Atlas, 7th edn. Brussels, Belgium: International Diabetes Federation, 2015. http://www.diabetesatlas.org