Alimera Sciences presents results from US trial of ILUVIEN® as baseline therapy in patients with early diabetic macular oedema

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Alimera Sciences presents results from US trial of ILUVIEN^® as baseline therapy in patients with early diabetic macular oedema

3 September 2025 – Alimera Sciences Limited, an ANI Pharmaceuticals, Inc. Company, today presented results of the first head-to-head clinical trial for ILUVIEN 190 micrograms intravitreal implant in applicator (fluocinolone acetonide) and the anti-VEGF aflibercept 2mg. Results from the US NEW DAY trial in patients with early diabetic macular oedema (DMO) were presented for the first time in Europe at the EURETINA Innovation Spotlight (EIS) in Paris by study investigator Dr Charles Wykoff of Retina Consultants of Texas, USA.

As a US study, NEW DAY follows the US indication for ILUVIEN where it is approved for the treatment of diabetic macular edema (DME) [or DMO] in patients who have been previously treated with a course of corticosteroids and did not experience a clinically significant rise in intraocular pressure. All DMO treatment-naïve or almost naïve patients enrolled in the trial therefore received a topical steroid challenge for 2 weeks before being randomised. In Europe, ILUVIEN, a sustained-release treatment lasting up to 36 months, is indicated for the treatment of vision impairment associated with chronic DMO considered insufficiently responsive to available therapies.

The US trial results showed that following treatment with 1 injection of ILUVIEN and 4 placebo injections or 5 monthly injections of aflibercept, the intent-to-treat (ITT) population required 2.4 supplemental aflibercept injections in the ILUVIEN (n=154) arm vs 2.5 in the aflibercept (n=152) arm (p=0.756) (primary endpoint). Over the period of the 18-month study the ILUVIEN arm received a mean total of 3.4 injections (1 ILUVIEN, 2.4 aflibercept) compared to 7.5 in the aflibercept only arm.

The mean time from last treatment injection to first supplemental aflibercept injection was longer in the ILUVIEN arm (185.4 days vs 132.8 days in the aflibercept arm), reaching statistical significance (p<0.001). A third (33%) of patients in the ILUVIEN arm did not require a supplemental injection during the study compared to 30% in the aflibercept arm (p=0.678).

A post-hoc analysis was conducted on a subset of randomised patients without major protocol deviations—such as being enrolled or randomised despite not meeting eligibility criteria, receiving incorrect treatment, or being administered prohibited concomitant medications or therapies. In this Post-Hoc Patient (PP) Population, the ILUVIEN arm (n=128) demonstrated a statistically significant difference in the mean number of supplemental aflibercept injections compared to the aflibercept arm (n=134), with 1.8 vs. 2.5 injections, respectively (p=0.029).

In addition, secondary endpoints that assessed visual acuity and anatomic changes in the ITT population demonstrated non-inferiority between the ILUVIEN arm and the aflibercept arm. The mean change from baseline in best corrected visual acuity (BCVA) score over 18 months in patients who did not meet the prespecified non-inferiority margin of 4 ETDRS (Early Treatment Diabetic Retinopathy Study) letters was 1.8 in the ILUVIEN arm (n=154) versus 5.5 in the aflibercept arm (n=152) (p=0.080 at month 18). The mean change from baseline in central subfield thickness (CST) over 18 months in the ILUVIEN arm was -118.8µm compared to -113.6µm in the aflibercept arm (p=0.709 at month 18).

“We were pleased to see that ILUVIEN held its own against aflibercept in this trial. The results reinforce our understanding that while DME is VEGF-driven, inflammation also plays a role and data in both the ITT and the PP populations support the use of ILUVIEN earlier in the treatment pathway,” said Dr Michael A Singer of the University of Texas Health Science Center and one of the study investigators. “Perhaps clinicians might consider switching to ILUVIEN sooner for anti-VEGF non-responders when they have seen these results and reduce treatment burden for patients,” he added at a meeting for US investors in July.

ILUVIEN was well tolerated in the trial, with a safety profile that is consistent with data from prior ILUVIEN clinical trials and real-world use. In the ITT patient population, 41% of patients in the ILUVIEN arm experienced treatment-related treatment-emergent adverse events (mainly associated with cataract/subcapsular cataract (n=50) and increase in intraocular pressure (IOP) (n=24)), compared to 3% in the aflibercept arm. Serious treatment-related treatment-emergent adverse events were not seen in either arm.

"As a company dedicated to advancing retinal health and maintaining better vision longer, we are pleased to report innovation in the retina space. While the NEW DAY trial follows the US label, we hope the results will be of interest to clinicians in Europe. It provides important clinical evidence supporting the earlier use of long-acting corticosteroids in the DMO patient treatment pathway, demonstrating meaningful efficacy alongside a reduced treatment burden," said Dr. Steve Morris, Vice President, Medical Director and Head of Medical Affairs at Alimera Sciences.

About the NEW DAY trial

This US study of 306 eyes at 42 US centres was designed to assess the efficacy, safety and tolerability of intravitreal ILUVIEN^® implant as baseline therapy in patients with early DMO who were treatment-naïve, or almost naïve compared with aflibercept over an 18-month period.

NEW DAY is a randomised, masked, active-controlled, parallel-group, multi-centre US phase IV clinical trial comparing two treatment regimens:

• ILUVIEN^® intravitreal implant (0.19 mg) followed by supplemental aflibercept as needed per protocol criteria
• Intravitreal aflibercept loading dose followed by supplemental aflibercept as needed per protocol criteria

Primary Outcome Measure: The mean total number of supplemental aflibercept injections needed during the study from baseline to 18 months.

About ILUVIEN

www.ILUVIEN.co.uk

Alimera Sciences’ primary product is ILUVIEN 190 micrograms intravitreal implant in applicator (fluocinolone acetonide), injected into the back of the eye. Together, chemistry and technology enable long-acting, continuous, low dose, steroid release with ILUVIEN for up to 36 months.¹  ILUVIEN continuous microdosing results in near-zero order kinetics with stable steroid release for up to 3 years. Whilst most drugs are eliminated via first-order kinetics,² elimination with ILUVIEN is time rather than concentration dependent from approximately 6 months after administration.³ In the UK ILUVIEN is approved for the treatment of vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies³ and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.³

About Diabetic Macular Oedema (DMO)

DMO, the primary cause of vision loss associated with diabetic retinopathy,⁴ 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 DMO.⁵ The onset of DMO 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 DMO.⁶ All people with type 1 or type 2 diabetes are at risk of developing DMO.

About Alimera Sciences Limited, an ANI Pharmaceuticals, Inc. Company.

www.alimerasciences.co.uk

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.co.uk

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Date of preparation: September 2025

Job No: UK-ILV-MMM-2671

References:

¹ Habib MS. ILUVIEN® Technology in the Treatment of center-involving Diabetic Macular edema: a Review of the Literature. Ther Deliv 2018; 9: 547-556.

² Campochiaro PA, Brown DM, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology 2011; 118: 626-635.

³ ILUVIEN, Summary of Product Characteristics.

⁴ Chakravarthy U. Managing insufficiently responsive DMO patients. Post-NICE guidance. European Ophthalmic Review. Proceedings of a symposium presented at the Royal College of Ophthalmologists Annual Congress 2014 in Birmingham, UK 20-22^nd May 2014. 

⁵ I Klaassen, Van Noorden CJ, Schlingemann RO. Molecular basis of the inner blood-retinal barrier and its breakdown in diabetic macular edema and other pathological conditions. Prog Retin Eye Res 2013; 34: 19–48. 

⁶ Klein R, Klein BE, Moss SE, et al. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology. 1984; 91(12): 1464-74.