Alimera Announces Agreement with Jaeb Center for Health Research on Behalf of the DRCR Retina Network

Rhea-AI Summary

Alimera Sciences (Nasdaq: ALIM) announced an agreement with Jaeb Center for Health Research to conduct a clinical trial evaluating ILUVIEN versus observation in preventing vision loss from radiation retinopathy. The trial will involve 600 participants receiving plaque brachytherapy for choroidal melanoma, beginning in Q1 2023. The study aims to prevent or reduce macular edema and vision complications following radiation therapy. Notably, ILUVIEN is already approved for treating diabetic macular edema and has shown promising outcomes in other indications.

Positive

• Collaboration with a prestigious research network enhances credibility.
• Potential market expansion if ILUVIEN proves effective against radiation retinopathy.
• ILUVIEN's established approval for other indications suggests strong product viability.

Negative

• Trial results are uncertain, with inherent risks affecting future projections.

ILUVIEN or faricimab (6.0 mg) injections versus observation will be studied for the prevention of visual acuity loss due to radiation retinopathy

ATLANTA, Sept. 23, 2022 (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 it has entered into an agreement with the Jaeb Center for Health Research Foundation Inc. (JCHR), acting on the behalf of the DRCR Retina Network to support and provide ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant for “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 (Protocol AL)”.

The study, which is expected to begin in Q1 2023, is planned to include 600 participants with primary choroidal melanoma receiving treatment with plaque brachytherapy. The study 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 to be working with this prestigious network of physicians in evaluating ILUVIEN’s potential to address another unmet need affecting the retina,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “When utilized as baseline therapy, as in our New Day Study (NCT04469595) for diabetic macular edema, we believe ILUVIEN’s 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.”

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 3 years, 45% of patients have visual acuity 20/200 or worse. A treatment that prevents the development of RR, or dampens its severity, would have important consequences for many of these eyes that may be successfully treated for choroidal melanoma but will likely develop severe RR and loss of vision over time.

About the DRCR Retina Network

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).

About ILUVIEN

www.ILUVIEN.com

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., 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. 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. ILUVIEN is not approved for treatment of uveitis in the United States.

About Alimera Sciences, Inc.

www.alimerasciences.com

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, 2021 and the Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022, and June 30, 2022 which are 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 cassy.dump@precisionvh.com

For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com

FAQ

What is the purpose of Alimera's recent clinical trial involving ILUVIEN?

The trial aims to evaluate ILUVIEN compared to observation in preventing vision loss due to radiation retinopathy in patients receiving plaque brachytherapy.

How many participants are expected in Alimera's ILUVIEN clinical trial?

The clinical trial is planned to include 600 participants.

When is the ILUVIEN clinical trial expected to start?

The trial is expected to begin in Q1 2023.

What complications does the ILUVIEN trial aim to address?

The trial aims to address macular edema and long-term visual acuity effects resulting from radiation therapy.

What is radiation retinopathy and why is it significant?

Radiation retinopathy is a complication that can lead to severe vision loss after treatment for choroidal melanoma, making its prevention significant for patient outcomes.