Studies back intravitreal steroid implant for macular edema
- 03-04-2026
- Diabetic Retinopathy
- News
medwireNews: Treatment of diabetic macular edema (DME) with the fluocinolone acetonide (FAc) implant may not lessen the need for rescue therapy compared with aflibercept, but it delivers comparable visual and anatomical improvements with fewer injections overall, suggests the NEW DAY study.
Visual and anatomical improvements with the FAc implant have also been found in a separate single-arm, observational study of patients with inflammatory ME.
FAc implant versus aflibercept in DME
Michael Singer (Medical Center Ophthalmology Associates, San Antonio, Texas, USA) and fellow NEW DAY trialists explain that the “FAc 0.19 mg implant is a sustained-release intravitreal drug-delivery system that is designed to deliver a continuous low dose (0.2 µg/day) of FAc in the vitreous humor for up to 36 months.”
For the phase 4 study, published in Ophthalmology, they compared the FAc implant with aflibercept as a baseline therapy followed by rescue supplemental injections of aflibercept as needed in adults with type 1 or 2 diabetes who had center-involving DME confirmed by central subfield thickness (CST).
The primary endpoint of the trial was not met, with the treatment groups needing a comparable number of rescue supplemental injections over 18 months of follow-up, at 2.4 for the FAc implant group and 2.5 for those receiving aflibercept.
However, the researchers found that “FAc-treated participants achieved similar visual and anatomic improvements as those receiving aflibercept with fewer than half the number of total injections throughout the study.”
A total of 306 people (306 eyes) were randomly assigned to receive treatment; 154 patients received the FAc 0.19 mg implant, while 152 were given aflibercept 2 mg every 4 weeks for five consecutive injections. During this induction phase, the FAc implant group received sham injections. Between months 5 and 18, both groups received supplemental aflibercept 2 mg/0.05 mL injections as needed.
The mean age of the participants was 61.4 years, 62.7% were men, and 80.5% were White. The patients were treatment naïve or had received no more than one ranibizumab or bevacizumab intravitreal DME treatment in the preceding 12 months, or no more than four intravitreal anti-vascular endothelial growth factor (VEGF) injections in total.
At baseline, the mean Best Corrected Visual Acuity (BCVA) was 66.0 letters (Snellen equivalent 20/50) and the mean CST was 461 µm. The mean intraocular pressure (IOP) was 17.2 mmHg and almost none of the patients were receiving IOP-lowering medication.
While the two treatment groups had a comparable need for supplemental aflibercept injections, Singer and team point out that taking into account the number of injections given during the induction phase (excluding sham injections in the FAc implant group), the total number of injections was fewer for the FAc implant group than the aflibercept group, at a mean of 3.4 versus 7.2.
They also found that the time to first supplemental injection was significantly longer for the Fac implant group than the aflibercept group, at a mean of 185 days compared with 133 days.
Approximately one third of patients did not need supplemental injections, irrespective of treatment type.
There was no significant difference in visual and anatomical improvements between the treatment groups, with BCVA increasing from baseline by 1.8 letters in the patients receiving the FAc implant and by 5.5 letters in those given aflibercept. The corresponding decreases in CST were 119 µm and 114 µm.
The study authors found that “[s]afety findings were aligned with established class effects.” As expected, the FAc implant group had more cataract procedures than the aflibercept group (27.9 vs 6.6%) and were more likely to have increased IOP (15.6 vs 3.3%), but there were “no new safety signals.”
They point out that “IOP elevations were generally predictable and typically managed with topical medications,” and note that “incisional IOP surgery remained uncommon,” being needed for three participants in the FAc implant group versus none of those receiving aflibercept.
Singer et al conclude that the study findings provide “robust evidence to inform the use of steroids in combination with anti-[vascular endothelial growth factor] bolus rescue therapy in the management of DME.”
Real-world support for FAc implant in inflammatory ME
The FAc implant may also be effective in uveitis or postoperative ME, according to observational, retrospective findings published in Eye.
The study included 62 patients (73 eyes; mean age 68.1 years; 56% men) who received the FAc implant between June 2020 and January 2024 for recurrent uveitis (42.5%) or postoperative ME (57.5%), having already been given at least two dexamethasone (DEX) implants, and had at least 6 months of follow-up. The gap between DEX implants and the introduction of FAc was generally up to 4 weeks.
BCVA improved in these patients from a median of 69.5 letters at baseline to 75.0 letters at 6 months, and this benefit was sustained for 24 months.
Similarly, median CMT improved from 409 µm at baseline to 305 µm at 6 months, dropping further to 283 µm at 24 months.
Over the mean follow-up of 16.8 months, additional intravitreal treatment was needed by fewer than half (47.9%) of the patients, and the probability of needing a rescue injection of DEX 12 months after treatment was 46%.
Regarding the safety profile, ocular hypertension (IOP ≥25 mmHg or IOP increase ≥10 mmHg) occurred in eight (11%) eyes, which resolved with eye drops in most cases, and required surgery in only two eyes.
Laurent Kodjikian (Hôpital Universitaire de la Croix-Rousse, Hospices Civils de Lyon, France) and colleagues recommend that “the effectiveness of FAc-implant should be evaluated by discussing the risk/benefit balance with the patient, by taking into account the reduction in treatment burden, the risk of [ocular hypertension], and the need for regular ophthalmic evaluation.”
They conclude: “This treatment strategy could thus be considered in carefully selected patients who have responded well and safely to prior DEX-implant, with the aim to limit additional treatments and visits, prevent the recurrence of inflammatory [macular edema], and reduce anatomical fluctuations, which are crucial for the patient’s visual prognosis.”
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