“We welcome the decision to review the most up to date evidence for ILUVIEN. The current NICE guidance restricting reimbursement to pseudophakic eyes has the unintended consequence of limiting the treatment options available to UK patients with a natural lens,” said Dan Myers, Alimera’s chief executive officer. “We believe expanded reimbursement of ILUVIEN would help many patients and aid the NHS in managing its resources more effectively.”
It is hoped that revision of NICE guidance can lift the pseudophakic only lens reimbursement restriction and allow Ophthalmologists availability of ILUVIEN for all patients under the current indication. This would be a significant improvement in reimbursement guidance as best estimates suggest that less than a third of chronic DME patients in England and Wales have an artificial lens.
“NICE’s reappraisal of ILUVIEN in phakic eyes is a development that will be welcomed by UK retinal specialists,” said Fahd Qhill, Consultant Ophthalmic Surgeon from The Royal Hallamshire Hospital in Sheffield, England. “It will fulfill an unmet clinical need in our phakic patients with chronic diabetic macular edema insufficiently responsive to available therapies. At present our treatment options are restricted in this cohort of patients.”
The Company expects the Technology Assessment 301 part-appraisal to be completed in 2019.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in the EU to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. (or US indication). 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 this persistent disease consistently every day., enabling the physician to treat this persistent 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 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 portfolio. 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, that the NICE part-appraisal is expected to be completed in 2019 and that the revision of NICE guidance will allow Ophthalmologists availability of ILUVIEN in all patients under the current indication. 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 timing of any revision of NICE guidance and if the NICE guidance is revised, acceptance by physicians and hospitals of these revisions 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, 2017 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, 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. 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.
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