The UK National Institute for Health and Care Excellence (NICE) Issues Final Draft Guidance to Provide Patients with a Natural Lens (Phakic Eye) Being Treated for Chronic Diabetic Macular Edema Access to ILUVIEN®
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Insights
The recommendation by the National Institute for Health and Care Excellence (NICE) for the use of ILUVIEN in the treatment of chronic diabetic macular edema (DME) in phakic patients is a significant development in the management of this condition. The sustained-release treatment, which lasts up to 36 months, offers a long-term management option for a condition that affects a considerable portion of the DME patient population in the United Kingdom. The extended duration of efficacy can potentially reduce the frequency of treatment and associated healthcare visits, which may lead to improved patient compliance and outcomes.
From a research perspective, the approval of ILUVIEN for this wider patient group is indicative of a positive response to clinical trial data and real-world outcomes. It reflects the efficacy and safety profile of the treatment and its ability to meet a significant unmet need within the DME treatment landscape. The decision by NICE also suggests confidence in the cost-effectiveness of the treatment, given that NICE assessments are heavily based on the cost-benefit analysis of treatments within the NHS framework.
The endorsement by NICE for ILUVIEN's use in the NHS carries substantial economic implications. Firstly, the decision to fund the treatment through the NHS after a set period post-publication indicates a commitment to allocate resources for a therapy that could potentially mitigate long-term healthcare costs associated with chronic DME. By providing a sustained-release treatment option, the NHS may expect to see reduced expenditures on more frequent interventions and management of complications arising from recurrent DME episodes.
Moreover, the integration of ILUVIEN into the NHS treatment regimen for DME could serve as a model for other healthcare systems evaluating similar long-term treatments. The economic impact of this decision will likely be scrutinized for its effect on patient quality of life and the overall cost savings to the healthcare system, which could influence future funding decisions for chronic diseases management within the NHS and beyond.
Alimera Sciences' announcement regarding NICE's recommendation has potential implications for the company's financial performance. As a publicly traded entity on the Nasdaq, Alimera Sciences could see an impact on its stock valuation due to this development. The expansion of the patient base eligible for ILUVIEN treatment in the UK could lead to increased revenue streams for the company.
Investors should note the potential for market growth within the UK and possibly in other regions that might adopt similar guidelines. The financial outlook for Alimera Sciences will likely be influenced by the uptake of ILUVIEN post-guidance publication, the pricing strategy within the NHS framework and the operational efficiency in meeting the increased demand. Long-term, the company's performance in the retinal health sector could be bolstered by this decision, provided that ILUVIEN maintains a strong safety and efficacy profile and manages to establish a significant market share.
NICE Final Draft Guidance recommends providing National Health System (NHS) patients with a phakic lens access to the only sustained-release treatment lasting up to 36 months for chronic diabetic macular edema (DME)
ATLANTA, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, announces that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending that patients with a natural lens (phakic patients) being treated for chronic diabetic macular edema (DME) have access to ILUVIEN 190 microgram intravitreal implant in applicator (fluocinolone acetonide).
“This is great news that NICE has issued final draft guidance to make ILUVIEN available for phakic patients suffering with chronic DME,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “These patients represent up to
NICE is recommending on label access to ILUVIEN as an option for treating visual impairment caused by chronic DME in phakic eyes. The Final Guidance for ILUVIEN in phakic eyes will be issued after February 22, 2024, when it will be combined with the previous NICE recommendation for patients with a pseudophakic lens and re-issued as a single updated guidance from NICE.
NHS England has agreed with the Integrated Care Boards (ICB’s) to provide funding to implement this guidance 30 days after publication. NHS Wales will usually fund within 2 months of the final draft guidance.
*From the UK Macular Society submission included in the NICE TA824 review, page 9.
About ILUVIEN
https://iluvien.co.uk/prescribing-information/
The Company’s primary product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, 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 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., 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. 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. ILUVIEN is marketed for the non-infectious posterior uveitis indication in Germany, France, the U.K., the Netherlands, Portugal, Spain, Austria, Ireland and Italy. ILUVIEN is not approved for treatment of uveitis in the United States.
About Alimera Sciences, Inc.
Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com.
Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, Alimera’s expectations with respect to NICE issuing a Final Guidance document. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “contemplates,” “predict,” “project,” “target,” “likely,” “potential,” “continue,” “ongoing,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based on current expectations and involve inherent risks and uncertainties (some of which are beyond Alimera’s control), including factors that could delay, divert, or change any of them, and could cause actual results to differ materially from those projected in these forward-looking statements.
These risks and uncertainties include, but are not limited to, the reaction of physicians in the United Kingdom to the inclusion of phakic patients in the NICE guidance for ILUVIEN, including those physicians’ willingness and ability to use ILUVIEN to treat appropriate patients, as well as those factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s most recently filed Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q, and any of Alimera’s subsequent filings with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.
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 on the forward-looking statements Alimera makes or that are made on its behalf as predictions of future events. These forward-looking statements speak only as of the date of this press release. Alimera undertakes no obligation to publicly update or revise any of the forward-looking statements made in this press release, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
| For press inquiries: Jules Abraham for Alimera Sciences 917-885-7378 julesa@coreir.com | For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com |
FAQ
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