Difluprednate

Trial evaluated number of supplemental injections needed for the treatment of DME for patients on ILUVIEN versus the aflibercept arm Study Enrolled Treatment-Naïve, or Almost Naïve, Patients with DME Results presented by Michael A. Singer, M.D. in a paper-on-demand presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting Conference call scheduled for today at 8:30 am ET July 23, 2025 -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced results from the NEW DAY clinical trial of ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in patients with diabetic macular edema (DME). The results were presented in a paper-on-demand presentation by Michael A. Singer, M.D., Clinical Professor of Ophthalmology at University of Texas Health Science Center and Director of Clinical Research at Medical Center Ophthalmology Associates in Texas, for the American Society of Retina Specialists (ASRS) Annual Scientific Meeting. The primary endpoint of the trial was the mean total number of supplemental aflibercept injections needed for the treatment of DME in the ILUVIEN arm compared to the aflibercept arm over the 18-month study period in the intent-to-treat (ITT) population. Patients were randomized to an induction phase to receive either a single ILUVIEN injection or a series of 5 monthly injections of aflibercept, followed by supplemental aflibercept injections as needed. Treatment with ILUVIEN (n=154) demonstrated a numerical reduction in the mean number of supplemental aflibercept injections compared to the aflibercept arm (n=152) but did not reach the threshold for statistical significance (2.4 vs. 2.5; p=0.756), and therefore the primary endpoint was not met. The secondary endpoint of mean time from last treatment injection to first supplemental aflibercept injection was met with a mean time of 185.4 days in the ILUVIEN arm (n=154), compared to 132.8 days in the aflibercept arm (n=152) (p A post-hoc analysis was conducted on a subset of randomized patients without major protocol deviations—such as being enrolled or randomized 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). Patients randomized to the ILUVIEN arm therefore received a single ILUVIEN injection and a mean of 1.8 supplemental injections, for a total of 2.8 injections, compared to patients in the aflibercept arm, who received 5 initial aflibercept injections and a mean of 2.5 supplemental injections, for a total of 7.5 injections. “Research suggests that DME is a multifactorial disease driven not only by increased production of VEGF, but also chronic inflammation,” said Dr. Singer. “The NEW DAY study provides clinically meaningful data on ILUVIEN’s potential impact on treatment burden, including a statistically significant difference in time to first supplemental injection of aflibercept in the ILUVIEN arm compared to the aflibercept arm. This potential reduction in treatment burden can be critical for our patients with diabetic macular edema as their disease is multifactorial, necessitating multiple visits to medical specialists.” ILUVIEN is indicated for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. 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 -118.8 compared to -113.6 in the aflibercept arm (p=0.709 at month 18). Additional secondary endpoints will be further evaluated. “ILUVIEN is already an established treatment option for diabetic macular edema and the results of the NEW DAY trial further highlight its potential as an important option for patients impacted by this disease,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. “We believe these data have the potential to support earlier usage of ILUVIEN as part of its role in reducing treatment burden in DME. We are pleased to share the results at the ASRS meeting and look forward to presenting additional data in the future to further inform clinical decision-making.” For safety, 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 percent 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 percent in the aflibercept arm. Serious treatment-related treatment-emergent adverse events were not seen in either arm. Sixteen percent of patients in the ILUVIEN arm experienced an increase in IOP compared to 3 percent in the aflibercept arm. In the ILUVIEN arm, 11 percent of patients experienced an increase in IOP of ≥25 mmHg compared to 3 percent in the aflibercept arm. In the ILUVIEN arm, 4.5 percent of patients required any laser or incisional IOP-lowering intervention during the study compared to 1.3 percent in the aflibercept arm. NEW DAY is a prospective, multicenter, masked, randomized, active-controlled trial that enrolled 306 eyes of treatment-naïve, or almost naïve, DME patients at approximately 42 sites around the U.S. To be enrolled in the study, patients had to be ≥18 years old with a diagnosis of Type 1 or Type 2 diabetes with center-involving DME confirmed by SD-OCT and CST of ≥ 350µm and best corrected visual acuity (BCVA) of ≥35 ETDRS Letters and ≤80 ETDRS letters in the study eye at the screening visit. Patients were excluded from the study if, among other things, they had received the following in the study eye: intravitreal or periocular steroids, intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to screening visit; > 1 intravitreal injection of ranibizumab or bevacizumab in the last 12 months; or had received ranibizumab or bevacizumab ≤ 6 weeks prior to the screening visit. Patients were also screened with a steroid challenge of difluprednate QID for 2 weeks. Patients who were determined to have an IOP ≥25 mmHg or an increase ≥8 mmHg from the screening visit were excluded. Patients were randomized to either an ILUVIEN arm or an aflibercept arm. Patients in the ILUVIEN arm received an ILUVIEN intravitreal implant while patients in the aflibercept arm received five injections of anti-VEGF therapy (intravitreal aflibercept 2 mg) at four-week intervals for the first 16 weeks of the trial during an induction period. After the 16-week induction period, patients in both arms were evaluated every four weeks during a 13-month maintenance period and received supplemental aflibercept injections only as needed. The criteria for supplemental treatment was set by identical protocol in both arms. Patients in the ILUVIEN arm were also permitted to receive supplemental aflibercept injections during the induction period if needed by protocol criteria following the injection of ILUVIEN. During the maintenance period, patients in the aflibercept arm only received supplemental aflibercept injections if needed per protocol definition. The recommended dosing in the prescribing information for aflibercept is an injection once every 8 weeks following an injection every 4 weeks for the first 5 injections. The primary endpoint of the study was the mean number of supplemental aflibercept injections needed for the treatment of DME in the study eye during the study in the ITT population. Diabetic macular edema (DME) occurs when blood vessels leak into a part of the retina called the macula, causing swelling that can lead to blurry vision and vision loss. Over time, about 7% of people with diabetes will develop DME, and approximately 4% will develop clinically significant macular edema, which causes blurred vision in the early stage and may cause cumulative damage over the long term. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. The content above comes from the network. if any infringement, please contact us to modify.