Alimera Sciences To Host ILUVIEN Live Webinar Launch Event

ATLANTA, Feb. 17, 2015 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced it will host a live webinar for eye care professionals on Monday, March 2, 2015, at 8:30 p.m. EST, during which eight leading retinal specialists and one glaucoma specialist from around the country will share their early experiences with ILUVIEN^® (fluocinolone acetonide intravitreal implant) 0.19mg. Initial nationwide shipments of ILUVIEN, the first treatment for diabetic macular edema (DME) that provides 36 months of sustained drug delivery in a single intravitreal implant, will begin nationally on February 23, 2015.

The one-hour launch event, accessible online through a live webcast, will feature ILUVIEN case studies, previously recorded ILUVIEN injections and a live audience Q&A. This webcast is specifically designed for the professional eye care community and will allow physicians to freely exchange information on ILUVIEN with their colleagues in an open forum. Alimera executives will be on hand, as well, to address questions related to product distribution and reimbursement opportunities. Those interested in registering for the webinar are encouraged to do so in advance at www.ILUVIEN.com.

“We are very excited to announce the official U.S. commercial launch of ILUVIEN with the retinal community, many of whom have closely followed the development and approval of the product over the years. We chose this novel webinar launch approach in order to disseminate information about ILUVIEN to them as efficiently and effectively as possible,” said Dan Myers, president and chief executive officer of Alimera. “It is our hope that by providing this open discussion platform, physicians will feel empowered to take advantage of this cutting-edge treatment option and make it quickly available to their appropriate DME patients.”

ILUVIEN was approved by the U.S. Food and Drug Administration (the FDA) in September 2014 to treat DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). It is expected that ILUVIEN will be reimbursed per its FDA indication. Alimera has a reimbursement and patient assistance program, AccessPlus, which is available to support practices and patients.

“The proven effectiveness combined with the inherent convenience of a multiyear drug delivery system delivered in a single injection has had DME patients and the retinal community eagerly awaiting ILUVIEN’s commercial availability,” said Nancy Holekamp, M.D., retina specialist at Pepose Vision, Chesterfield, Missouri, and moderator of the webinar event. “DME patients can be challenging, and while treatment options have improved greatly in recent years, they still often require multiple injections and can be burdensome to the patient. ILUVIEN expands our ability to treat these patients with an implant that slowly releases a corticosteroid for 36 months.”

In addition to Dr. Holekamp, other webinar presenters include: Dr. David Brown, Retina Consultants of Houston, Houston, Texas; Dr. Pravin Dugel, Retinal Consultants of Arizona, Phoenix, Arizona; Dr. Alexander Eaton, Retina Health Center, Fort Myers, Florida; Dr. Victor Gonzalez, Valley Retina Institute, McAllen, Texas; Dr. Peter Kaiser, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Dr. Szilàrd Kiss, Weill Cornell Medical College, New York-Presbyterian Hospital, New York, New York; Dr. Baruch Kuppermann, U.C. Irvine Medical Center, Orange, California; and Dr. Thomas Mundorf, Mundorf Eye Center, Novant Health Presbyterian Medical Center, Charlotte, North Carolina.

“As retina specialists, we continuously strive to help our patients preserve their vision and their quality of life. While the DME treatment option landscape has expanded over the past several years, we do see a significant percentage of patients who don’t respond or eventually fail to respond,” said Dr. Kiss. “ILUVIEN gives us a truly long-lasting and effective treatment to add to our DME arsenal and gives our patients additional hope that their visual acuity can be maintained.”

About ILUVIEN

ILUVIEN^® (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide (FAc), a corticosteroid, for 36 months.

Corticosteroids have a history of effective use in treating ocular disease inflammation. ILUVIEN is injected in the back of the patient’s eye with an applicator that employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME Study, a phase 3 clinical study of ILUVIEN, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.

Please see www.ILUVIEN.com for additional information.

ILUVIEN Important Safety Information

Contraindication

• ILUVIEN is a contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.
• ILUVIEN is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.
• ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product.

Warnings and Precautions

• Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection.
• Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
• Patients in whom the posterior capsule of the lens in absent or has a tear are at risk of implant migration into the anterior chamber.

Adverse Reactions

• In controlled studies, the most common adverse reactions reported were cataract development (ILUVIEN 82%; sham 50%) and intraocular pressure elevation of greater than 10 mmHg (ILUVIEN 34%; sham 10%).

Patients are advised to have follow-up eye examinations at appropriate intervals following treatment with ILUVIEN. For full prescribing information, log onto www.ILUVIEN.com.

About 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 of diabetic retinopathy causes swelling in the macula, the condition has progressed to 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. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes studied were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.

Duration of diabetes is a risk factor for increased retinopathy which is associated with an increased prevalence of DME. The appearance of retinopathy is associated with an upregulation of vascular endothelial growth factor (VEGF) causing an increase in permeability of vessels leading to leakage of fluid. As retinopathy worsens, an up-regulation of multiple cytokines (inflammatory factors) takes place.

About Alimera Sciences, Inc.

Alimera Sciences, Inc., headquartered in Alpharetta, Georgia, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera’s European operations are conducted from London by its subsidiary, Alimera Sciences Limited. For more information, please visit www.alimerasciences.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 availability of ILUVIEN in the U.S. and expectations regarding the annual incidence of diagnosed DME. 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, uncertainty as to Alimera’s ability to commercialize, and market acceptance of, ILUVIEN in the United States, 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, 2013 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. 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.

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SOURCE Alimera Sciences, Inc.