Alimera Sciences Europe Limited (“Alimera”), a wholly owned subsidiary of Alimera Sciences, Inc., and Tanner Pharma UK Limited (“Tanner”) announced today the initiation of a Named Patient Program for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg globally for the treatment of diabetic macular edema (DME) and in Europe and the Middle East, for the treatment of non-infectious posterior uveitis (NIU-PS).
ATLANTA, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences Europe Limited (“Alimera”), a wholly owned subsidiary of Alimera Sciences, Inc., and Tanner Pharma UK Limited (“Tanner”) announced today the initiation of a Named Patient Program for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg globally for the treatment of diabetic macular edema (DME) and in Europe and the Middle East, for the treatment of non-infectious posterior uveitis (NIU-PS).
The agreement names Tanner as the exclusive provider of ILUVIEN in specific countries outside of the United States on a named-patient basis where the product is not commercially available for patients with DME and NIU-PS.
“Alimera is excited to partner with Tanner to offer additional distribution of ILUVIEN to patients globally,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer. “This program will potentially help support patients with diabetic macular edema and non-infectious posterior uveitis who would otherwise not have access to a long-term option and will continue Alimera’s commitment to physicians and their patients with diseases of the retina.”
“We are proud to work with Alimera to make ILUVIEN available to patients in countries where it is not commercially available,” said Banks Bourne, Chairman and Founder of Tanner Pharma Group. “This partnership reflects the type of company and innovative product Tanner strives to offer.”
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant that is injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for up to 36 months, to reduce the recurrence of disease and number of treatments required, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E 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. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In March 2019, ILUVIEN received approval in the 17 countries under the Mutual Recognition Procedure for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is not approved for treatment of uveitis in the United States.
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 Non-Infectious Posterior Uveitis (NIU-PS)
Posterior segment non-infectious uveitis is a chronic, inflammatory disease affecting the posterior segment of the eye, often involving the retina, and is a leading cause of blindness in developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. Patients with NIU-PS are typically treated with systemic steroids, which are effective, but over time frequently lead to serious side effects, ranging from acne, weight gain, sleep and mood disorders to hypertension and osteoporosis that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which also can have severe side effects, including an increased risk of cancer and infection. As a result, there remains a significant need for new therapies with improved efficacy, tolerability, and safety profiles to manage this disease.
About Alimera Sciences
Alimera Sciences, Inc., is a pharmaceutical company that specializes in the commercialization 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 affect millions of people in our aging populations. Alimera Sciences Europe Limited is the company’s Irish subsidiary. For more information, please visit www.alimerasciences.com.
About Tanner Pharma Group
Tanner Pharma Group is a specialist pharmaceutical services provider based in Charlotte, USA with offices in Europe and Latin America. Over 18 years, Tanner has developed a portfolio of service offerings focused on improving the global access to medicines. Through its TannerMAP division, Tanner supports manufacturers by providing ethical, controlled and compliant access to their innovative medicines in countries where they are not commercially accessible. For more information, visit www.tannerpharma.com
Forward Looking Statements
This press release may contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s intent to offer additional distribution of ILUVIEN to patients globally and the potential to help support patients with diabetic macular edema and non-infectious posterior uveitis who would otherwise not have access to a long-term option. 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.
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.
| For press inquiries: Tanner Pharma Group | For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com |
