Alimera Announces First Patient Randomized in Radiation Retinopathy Trial Being Conducted by the DRCR Retina Network
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Insights
The commencement of a clinical trial, especially one involving a pharmaceutical product like ILUVIEN or faricimab, is a significant event for stakeholders in Alimera Sciences, Inc. The study's focus on preventing visual acuity loss due to radiation retinopathy in patients with choroidal melanoma is a step towards addressing a niche but critical healthcare need. The trial's outcome could potentially expand the indications for ILUVIEN, currently approved for diabetic macular edema, to include radiation retinopathy, thus broadening the product's market scope.
From a medical research perspective, the trial's design, which compares the efficacy of a corticosteroid implant and an anti-VEGF injection to observation, is structured to provide robust data on the effectiveness of proactive treatment. This is particularly important as radiation retinopathy can lead to significant visual impairment and current treatments are often initiated only after macular edema develops. If ILUVIEN's CONTINUOUS MICRODOSING™ delivery system shows benefits in this new indication, it could lead to a paradigm shift in how retinal complications from radiation therapy are managed.
For investors, the initiation of Protocol AL is a development that could have long-term financial implications for Alimera Sciences. The potential market expansion for ILUVIEN hinges on the successful demonstration of its efficacy in preventing radiation-induced eye diseases. The trial's successful outcome may lead to an increase in the product's addressable market, potentially driving revenue growth for the company.
However, the financial impact will not be immediate, as clinical trials typically span several years before a product can be approved for a new indication. Investors would do well to monitor the progress of the study and watch for interim results, which could serve as indicators of the trial's potential success and influence the company's stock performance. Additionally, considering the high costs associated with clinical trials, it is important to assess Alimera's financial health and its ability to sustain the investment over time without diluting shareholder value.
Understanding the medical context, radiation retinopathy is a condition that occurs following radiation treatment for intraocular cancers, such as choroidal melanoma. It can lead to vision loss and currently, there are limited preventive treatments available. The study's aim to evaluate the efficacy of ILUVIEN's sustained release implant versus faricimab's repeated injections is significant in the field of ophthalmology. Continuous microdosing could offer a more consistent therapeutic effect, potentially improving patient compliance and outcomes compared to traditional injection schedules.
Should ILUVIEN prove effective in this new indication, it would represent an advancement in retinal care, providing patients with a preventative treatment option that could maintain vision and quality of life. The study's design, including a large sample size and a comparison to observation, is well-suited to provide conclusive evidence that could influence clinical practice in the management of radiation retinopathy.
Protocol AL is studying ILUVIEN or faricimab (6.0 mg) injections versus observation for the prevention of visual acuity loss due to radiation retinopathy
ATLANTA, March 19, 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 first patient has been randomized in the DRCR Retina Network’s Protocol AL. The study is titled, “A Randomized Clinical Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy.”
The study, chaired by Arun Singh, M.D. (Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio), plans to include 600 participants with primary choroidal melanoma receiving treatment with plaque brachytherapy. It will assess development of macular edema and associated long-term visual acuity effects of consistent and continuous release of corticosteroid or repeated injections of anti-VEGF initiated near the time of radiation therapy compared to observation until macular edema develops in patients at risk for radiation retinopathy.
“We are very excited that this study is underway as it has the potential to show ILUVIEN addressing another unmet need affecting the retina,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “We believe ILUVIEN with CONTINUOUS MICRODOSING™ delivery may prevent, delay or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy and look forward to the continuing progress of this study.”
About Radiation Retinopathy
Radiation retinopathy (RR) is a common complication after Iodine-125 plaque brachytherapy for choroidal melanoma. Although the initial radiation insult is immediate, clinical onset of RR is not seen until many months later and RR frequently progresses over time to profound vision loss. The Collaborative Ocular Melanoma Study reported that at three years,
About the DRCR Retina Network (DRCR.net)
The DRCR Retina Network was formed in 2002 and includes clinical sites and physicians throughout the United States and Canada. It is funded by the National Eye Institute (NEI), part of the National Institutes of Health, which is the federal government agency that funds medical research. The DRCR Retina Network is supported in overall operation and leadership by the office of the Network Chairs (Daniel F. Martin, M.D., Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio and Jennifer K. Sun, M.D., M.P.H., Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts) and the Coordinating Center (Executive Director Adam R. Glassman, M.S., Jaeb Center for Health Research, Tampa, FL), and the National Eye Institute (Project Officer, Sangeeta Bhargava, Ph.D.).
About ILUVIEN
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. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in late 2019, Belgium in 2021 and Spain and Italy in 2022. Alimera markets YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg 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 contains “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 ILUVIEN’s potential to address another unmet need affecting the retina. 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, ILUVIEN’s ability to prevent or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy, 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, 2023 which is on file 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 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: Cassy Dump for Alimera Sciences 619-971-1887 cassydoespr@gmail.com | For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com |
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