ANI Pharmaceuticals, Inc. published the results from its NEW DAY clinical trial in Ophthalmology. The trial involved fluocinolone acetonide intravitreal implant, 0.19 mg (Iluvien) for use in appropriate patients with diabetic macular edema (DME), the company said in a press release. Iluvien is a corticosteroid indicated for the treatment of DME in patients who previously have been treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). The company announced results from the NEW DAY trial in July 2025.
The prospective, randomized, single-masked, active-controlled, multicenter, 18-month, phase 4 study assessed the efficacy and safety of the fluocinolone acetonide intravitreal implant, 0.19 mg as baseline therapy in DME. Participants included adults with type 1 or 2 diabetes and center-involving DME confirmed by central subfield thickness.
Among 517 patients screened, 306 were randomized. The primary endpoint—superiority of the mean number of rescue supplemental aflibercept injections—was similar between groups, with 2.4 injections in the fluocinolone acetonide group and 2.5 in the aflibercept group. When both protocol-mandated and rescue supplemental injections were included, patients treated with fluocinolone acetonide received fewer injections compared with aflibercept (3.4 vs 7.2 injections).
The study also showed that time to first rescue supplemental injection was longer with fluocinolone acetonide than with aflibercept (185.4 vs 132.8 days). The proportion of patients who did not require rescue supplemental injections was comparable between groups (32.5% vs 30.3%). In addition, mean change in best-corrected visual acuity was similar between groups (1.8 vs 5.5 letters; nominal P=0.08) as was the change in central subfield thickness (mean [SD] -119 vs -114 μm; nominal P=0.71). In the fluocinolone acetonide group, 27.9% received a cataract procedure vs 6.6% in the aflibercept group. Increased IOP occurred in 15.6% and 3.3% of participants in the fluocinolone acetonide and aflibercept groups, respectively.
Read the full study here.