ATLANTA and LONDON, Sept. 28, 2015 /PRNewswire/ -- Alimera Sciences Limited, the European subsidiary of Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced the availability of real world data from 28 injections of ILUVIEN® (Fluocinolone Acetonide 190 micrograms intravitreal implant in applicator) in Europe, presented in a review paper authored by Fahd Quhill, Consultant Ophthalmologist, Department of Ophthalmology, Royal Hallamshire Hospital, Sheffield, South Yorkshire, U.K.
The paper, entitled “Real World Experience of Fluocinolone Acetonide (0.2 micrograms/day) Intravitreal Implant in the Treatment of Diabetic Macular Edema,” reviews 28 cases from six sites in the U.K. and four sites in Germany, the first two countries in which ILUVIEN was launched by Alimera Sciences Limited.
The mean follow up after injection of ILUVIEN was 13 weeks in these case reports. The average change in the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline was an increase of 14 letters, with 15 eyes (54%) achieving greater than 10 letters of improvement and nine eyes (32%) achieving greater than 15 letters improvement. The average decrease in central foveal thickness (CFT) was 167 microns, while in 15 eyes (54%) CFT decreased to below 300 microns.
In these cases, each eye had received prior treatment, with 57% having been treated with corticosteroid, 57% having been treated with laser and 93% having been treated with anti-vascular endothelial growth factor (anti-VEGF) agents. Those eyes receiving prior anti-VEGF treatment received an average of 5.3 injections before ILUVIEN was administered, reflective of the current clinical practice and standard of care in the U.K. and Germany.
The use of corticosteroids is associated with accelerated development of cataract and elevated intraocular pressure (IOP). In these cases, the introduction of IOP lowering medication was required in two eyes (7%) compared with 38% in the FAME Study, Alimera’s pivotal phase 3 study.
“Real world data on the use of ILUVIEN in the U.K. and Germany, as collected in this series of cases, have shown efficacy equivalent to that seen in the FAME Study,” said Fahd Quhill, author of the paper. “In the limited number of cases reported in the public domain, the number of patients experiencing an elevation in IOP are fewer than reported in the FAME Study.”
“We are pleased that ILUVIEN continues to show such positive results in Europe, as demonstrated in these cases,” said Dan Myers, Alimera’s president and chief executive officer. “It is both exciting and encouraging to see patients enjoy significantly improved vision and reduced retinal edema after receiving ILUVIEN.”
About ILUVIEN®
ILUVIEN Fluocinolone Acetonide (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant indicated in the European Union for the treatment of vision impairment associated with chronic diabetic macular edema, considered insufficiently responsive to available therapies. Each ILUVIEN implant provides 36 months of sustained treatment achievable with one injection by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). The ILUVIEN implant is administered via a simple perpendicular intravitreal injection. The applicator employs a 25-gauge needle, which produces a small self-sealing wound in the pars plana. In the two randomised, multicentre, double-masked, parallel phase 3 clinical trials of ILUVIEN, collectively known as the FAME Study, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.
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. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.
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.
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 efficacy and safety of ILUVIEN® and assumptions regarding the prevalence of 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, the possibility that the continued findings in this case series differ materially from the interim results reported here and uncertainty as to physician acceptance of the case series, 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, 2014 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, 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 Limited
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