Provide expert-informed guidance on the integration of aflibercept 8 mg into routine clinical care for patients with neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DMO), based on clinical trial and real-world evidence. Sixteen retina specialists ('experts') met during the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in May 2025 to discuss the clinical use of aflibercept 8 mg. A post-meeting online platform was used to collect additional independent input. Agreement was captured using binary responses and categorised as: all agreed (100%), majority agreed ( ≥ 75%), most agreed (50-74%), or non-consensus ( ≤ 50%). All experts agreed that aflibercept 8 mg may be considered as a first-line treatment in treatment-naïve patients with nAMD and DMO, and switching to aflibercept 8 mg can be considered for previously treated patients. The majority of experts agreed that switching patients with well-controlled disease on shorter or intermediate dosing intervals may enable further interval extension while maintaining disease control, and switching patients with poorly controlled disease may optimise anatomical outcomes and improve stability. Most experts agreed that three initial monthly loading doses are appropriate in newly diagnosed patients. No consensus was reached on optimal dosing-decision strategies after switching in patients with poorly controlled disease, nor on the timing of initial interval modification during treatment initiation. These expert opinions, informed by available, emerging clinical evidence and real-world clinical experience, support aflibercept 8 mg as a first-line and switch option for nAMD and DMO, using personalised treatment approaches for both treatment-naïve and previously treated patients.
Purpose of review Geographic atrophy, the advanced form of dry age-related macular degeneration (AMD), has historically been evaluated using structural endpoints and best-corrected visual acuity (BCVA). This review examines the growing rationale for a function-first approach. Recent findings Emerging data demonstrate that functional deficits often decline earlier and more profoundly than BCVA. Recently approved complement inhibitors have shown slowing of geographic atrophy lesion growth but without consistent improvements in traditional visual acuity endpoints. Extension studies and post hoc analyses suggest some functional benefits. Next-generation therapies are increasingly incorporating functional endpoints into trial design. Summary Structural slowing alone does not fully capture therapeutic value in geographic atrophy. Functional measures provide a more sensitive and patient-centered assessment of disease progression and treatment impact.
PURPOSE:To report the efficacy, durability, and safety of intravitreal aflibercept 8 mg versus intravitreal aflibercept 2 mg every 8 weeks (2q8) in patients with neovascular age-related macular degeneration (nAMD) through 96 weeks, PULSAR (ClinicalTrials.gov identifier, NCT04423718). DESIGN:Phase 3, randomized, noninferiority, 96-week trial. PARTICIPANTS:Treatment-naive adults ≥ 50 years with nAMD. METHODS:Patients were randomized 1:1:1 to intravitreal aflibercept 8 mg every 12 or 16 weeks (8q12 or 8q16), or 2q8, after 3 initial monthly doses; dosing intervals in 8-mg groups were modified based on prespecified criteria. MAIN OUTCOME MEASURES:Change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), proportion of patients maintaining or extending the randomized dosing intervals, and safety outcomes. RESULTS:Of 1009 patients treated, 869 patients (8q12, n = 291; 8q16, n = 292; 2q8, n = 286) completed treatment through week 96. Least squares (LS) mean change from baseline in BCVA at week 96 was +5.6 (95% confidence interval [Cl], 4.1-7.1), +5.5 (95% Cl, 4.0-7.0), and +6.6 (95% Cl, 5.2-8.0) letters in the 8q12, 8q16, and 2q8 groups, respectively; 8q12 and 8q16 differences versus 2q8 in LS mean BCVA changes at week 96 met the noninferiority criteria specified for the primary end point at week 48. Mean (standard deviation) change in CRT from baseline was -143.9 (123.6) μm, -153.4 (140.8) μm, and -135.8 (133.1) μm in the 8q12, 8q16, and 2q8 groups, respectively. Patients completing 96 weeks of treatment in the 8q12, 8q16, and 2q8 groups received a mean of 9.7, 8.2, and 12.8 active injections, respectively. Of these, 87% of patients in the 8q12 group had last assigned dosing intervals of 12 weeks or more, whereas 78%, 53%, and 31% of patients in the 8q16 group qualified for last assigned dosing intervals of ≥ 16 weeks, ≥ 20 weeks, and 24 weeks, respectively. Incidence of ocular treatment-emergent adverse events was similar across groups. CONCLUSIONS:Aflibercept 8 mg delivered sustained disease control in patients with nAMD, maintaining improvements in visual and anatomic outcomes through week 96 with extended dosing intervals and similar safety profile to aflibercept 2 mg. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Objective This real-world retrospective case series evaluates the safety and efficacy of aflibercept 8 mg in patients diagnosed with neovascular age-related macular degeneration (nAMD).Methods and analyses Treatment-naïve or treatment-experienced patients with nAMD receiving aflibercept 8 mg with at least 6 months of follow-up were assessed.Results 40 eyes from 33 patients were included, of which 36/40 eyes were previously treated. The mean age of subjects is 79.84 years. At baseline, 29/36 eyes had intraretinal fluid (IRF)/subretinal fluid (SRF) at an average interval of 40.97 days, logMAR VA of 0.346, and average central subfield thickness (CST) of 341.53 µm. At final follow-up, average logMAR VA was 0.315 and average CST decreased by 39.39 µm, with an average number of days since last treatment of 52.9. Of the 32 eyes with IRF, SRF, or both at the time of switch, 12 eyes achieved anatomical quiescence without IRF/SRF after the first injection of aflibercept 8 mg, including three of four treatment-naive patients.Conclusions This early case series suggests that patients treated with aflibercept 8 mg may achieve greater duration between treatments while preserving and, in some cases, improving visual acuity and anatomical outcomes in a real-world clinic setting. In this retrospective study, the patient population primarily consisted of treatment-experienced cases with recalcitrant disease or high treatment burdens, potentially using aflibercept 8 mg as salvage therapy. This selection bias limits generalisability to broader real-world populations. The small sample size precludes formal statistical conclusions. Multiple investigators made unstandardised treatment decisions based on individual clinical judgement, including whether to continue aflibercept 8 mg or revert to prior therapy, sometimes after just one injection.
Assess real-world efficacy and safety of intravitreal faricimab in the management of central serous chorioretinopathy (CSCR) associated choroidal neovascularization (CNV). In this multicenter retrospective study, Patients receiving one or more intravitreal faricimab injections for CSCR-associated CNV were included. Subgroup analysis involved both treatment-naïve individuals and those switched from prior anti-VEGF agents. Clinical and anatomical parameters including best-recorded visual acuity (BRVA), central macular thickness (CMT), subfoveal choroidal thickness (SFCT), neurosensory detachment (NSD), and pigment epithelial detachment (PED) height—were assessed at baseline and at one month after the first and third injections. Treatment response was categorized as complete resolution (absence of subretinal fluid [SRF]/intraretinal fluid [IRF]), optimal (> 50
What is this summary about? • This is a summary of a publication about the PULSAR study, which was published in The Lancet scientific journal. • Wet age-related macular degeneration (or AMD) is a long-term eye disease in which abnormal blood vessels grow in the back of the eye. As these vessels leak fluid or blood, the word “wet” is part of the disease name. This affects the central part of a person’s vision, which can make it hard for people to read, drive, or perform other daily activities. It is one of the main causes of visual loss in older people, and if it is left untreated, it can lead to rapid loss of vision. • People with wet AMD can be treated with anti-vascular endothelial growth factor (or anti- VEGF ) medicine, given as an injection into the back of the eye. This type of medicine can improve vision by directly reducing the leakage into the macula and by stopping the growth of new, abnormal blood vessels. This leads to reduced swelling of the macula , which is measured by central retinal thickness. These therapies need frequent eye injections. One of the biggest difficulties for many people and their caregivers is that they need to keep up with visits for their injections that are often required to maintain good vision. • Aflibercept is an anti- VEGF medicine that health authorities across different countries have approved for the treatment of wet AMD, as well as other eye diseases, which we will not discuss in this material. People with wet AMD can receive injections of aflibercept 2 mg, given initially once per month for three months. After that, people usually receive treatment every 8 weeks, or sometimes less frequently, depending on their doctors’ assessments of the disease state. • The PULSAR study was carried out to see if a higher, 8 mg, dose of aflibercept would provide the same treatment results as aflibercept 2 mg, but with the need for fewer injections. If fewer injections are necessary, this can potentially help patients and their caregivers keep up with treatment. • The PULSAR study involved a direct comparison of the two doses of this anti-VEGF medicine in patients with wet AMD who were placed into one of three treatment groups with different dosing intervals at random. What were the results? • Through the first year (or 48 weeks), participants who received injections of aflibercept 8 mg every 12 or 16 weeks after an injection once per month for three months, had improvements in vision that were similar to those of participants treated with aflibercept 2 mg every 8 weeks. • After the injection once per month for three months, at Week 16, there were fewer participants treated with the 8 mg dose who had abnormal fluid leakage in the macula compared to the 2 mg dose. • At Week 48, participants who received aflibercept 8 mg had similar decreases in the thickness of the retina in the central region as those treated with aflibercept 2 mg. • Most participants who received aflibercept 8 mg and completed 48 weeks of the study maintained their 12- or 16-week injection schedules, without needing to shorten the interval between injections. • Adverse events in participants treated with aflibercept 8 mg were also similar to those in participants treated with aflibercept 2 mg. What do the results mean? • Findings show that aflibercept 8 mg can improve vision to the same extent as aflibercept 2 mg in people with wet AMD, but with fewer injections than aflibercept 2 mg so that people can potentially keep up with their treatments more easily.
Purpose: To evaluate the early real-world clinical outcomes regarding the safety and efficacy after administration of a ranibizumab biosimilar (Ranieyes). Methods: This multicenter retrospective uncontrolled observational study incorporated data from 7 centers in India. All patients were treated with at least 1 intravitreal injection of 0.5 mg of ranibizumab biosimilar between July 2022 and July 2023 for various indications. Results: A total of 474 ranibizumab biosimilar injections were given in 268 eyes of 254 patients. Indications were diabetic macular edema (DME) (n = 112), macular neovascularization (MNV) (n = 92), retinal vein occlusion (RVO) (n = 54), cystoid macular edema (n = 4), and proliferative diabetic retinopathy with vitreous hemorrhage (n = 6). The mean logMAR BCVA (±SD) improved significantly from baseline to the last follow-up as follows: DME cases, from 0.77 ± 0.37 (Snellen equivalent, 6/36) to 0.43 ± 0.25 (6/15) ( z = −8.0; r = −0.8); MNV cases, from 0.95 ± 0.53 (6/60) to 0.59 ± 0.42 (6/24) ( z = −7.1; r = −0.8); RVO cases, from 0.83 ± 0.40 (6/45) to 0.44 ± 0.32 (6/15) ( z = −5.5; r = −0.8) (all P < .001). All groups also had significant improvement in the central subfield thickness (all P < .001). No site reported drug-related adverse events (eg, inflammation, vasculitis, systemic adverse effects). Conclusions: The preliminary real-world data from this limited early series suggest that Ranieyes has clinical efficacy and is safe as a ranibizumab biosimilar across the approved indications.
Purpose: To evaluate the efficacy of intravitreal (IVT) pegcetacoplan monthly vs avacincaptad pegol monthly (primary analysis), and pegcetacoplan every other month vs avacincaptad pegol monthly (secondary analysis), for geographic atrophy (GA). Methods: Matching-adjusted indirect comparisons (MAIC) were conducted across global phase 3 trials using individual patient data from 2 pegcetacoplan trials (OAKS, NCT03525613; DERBY, NCT03525600) and published aggregate data from the avacincaptad pegol GATHER2 trial (NCT04435366). GATHER2 inclusion and exclusion criteria were applied to the OAKS and DERBY individual patient data. Key baseline variables were balanced using propensity score weighting. GA lesion growth at month 12 was assessed. Results from the MAIC were combined using meta-analysis. Results: The primary analysis included 103 patients from OAKS and 102 patients from DERBY who met the GATHER2 inclusion and exclusion criteria, and 447 patients from GATHER2. In OAKS vs GATHER2, the adjusted difference in GA lesion growth at month 12 between pegcetacoplan monthly and avacincaptad pegol was -0.716 mm2 (95% CI, -1.385 to -0.046; P = .04), statistically favoring pegcetacoplan monthly. In DERBY vs GATHER2, the adjusted difference was -0.234 mm2 (95% CI, -1.354 to 0.885; P = .68), directionally favoring pegcetacoplan monthly. After meta-analysis, the pooled effect for pegcetacoplan monthly vs avacincaptad pegol was -0.589 mm2 (95% CI, -1.164 to -0.014; P = 0.04), statistically favoring pegcetacoplan monthly. A numerically greater reduction in GA lesion growth was observed with pegcetacoplan every other month vs avacincaptad pegol monthly (95% CI, -1.130 to -0.300; P = .25). Conclusions: Matching-adjusted indirect comparisons support a greater reduction in GA growth with pegcetacoplan monthly vs avacincaptad pegol monthly and no significant difference between pegcetacoplan every other month and avacincaptad pegol monthly.
PurposeTo evaluate safety and tolerability of EYP-1901, an intravitreal insert containing vorolanib, a pan–vascular endothelial growth factor (VEGF) receptor inhibitor packaged in a bioerodible delivery technology (Durasert E™) for sustained delivery, in patients with wet age-related macular degeneration (wAMD) previously treated with anti-VEGF therapy.DesignPhase 1, multicenter, prospective, open-label, dose-escalation trial.ParticipantsPatients with wAMD and evidence of prior anti-VEGF therapy response.MethodsPatients received a single intravitreal injection of EYP-1901.Main Outcome MeasuresThe primary objective was to evaluate safety and tolerability of EYP-1901. Secondary objectives assessed biologic activity of EYP-1901 including best-corrected visual acuity (BCVA) and central subfield thickness (CST). Exploratory analyses included reduction in anti-VEGF treatment burden and supplemental injection-free rates.ResultsSeventeen patients enrolled in the 440 μg (3 patients), 1030 μg (1 patient), 2060 μg (8 patients), and 3090 μg (5 patients) dose cohorts. No dose-limiting toxicity, ocular serious adverse events (AEs), or systemic AEs related to EYP-1901 were observed. There was no evidence of ocular or systemic toxicity related to vorolanib or the delivery technology. Moderate ocular treatment-emergent AEs (TEAEs) included reduced visual acuity (2/17) and retinal exudates (3/17). One patient with reduced BCVA had 3 separate reductions of 17, 18, and 16 letters, and another had a single drop of 25 letters. One severe TEAE, neovascular AMD (i.e., worsening/progressive disease activity), was reported in 1 of 17 study eyes but deemed unrelated to treatment. Mean change from baseline (CFB) in BCVA was –3.7 letters and –5.4 letters at 6 and 12 months. Mean CFB in CST was +1.7 μm and +2.3 μm at 6 and 12 months. Reduction in treatment burden was 76% and 72% at 6 and 12 months. Of 16 study eyes, 13, 9, and 6 were injection-free up to 3, 6, and 12 months.ConclusionIn the DAVIO trial (ClinicalTrials.gov identifier, NCT04747197), EYP-1901 had a favorable safety profile and was well tolerated in previously treated eyes with wAMD. Measures of biologic activity remained relatively stable following a single EYP-1901 injection. These preliminary data support ongoing Phase 2 and planned Phase 3 trials to assess efficacy and safety.
PURPOSE:Disparities in clinical trials are a major problem because of significant underrepresentation of certain gender, racial, and ethnic groups. Several factors including stringent eligibility criteria and recruitment strategies hinder our understanding of retinal disease. Thus, we aimed to study the various reasons of screen failures and specific patient and study characteristics among screen failures. DESIGN:This is a cross-sectional retrospective study. METHODS:Screening data of 87 trials from 6 centers were analyzed. Study characteristics (disease studied, phase of trial, and route of drug administration) and patient demographics (age, gender, race, ethnicity, and employment status) were compared among different causes of screen failures. Screen failures were broadly classified into 6 categories: exclusion because of vision-based criteria, exclusion because of imaging findings, exclusion because of other factors, patient-related criteria, physician-related criteria, and miscellaneous. Descriptive statistics, Pearson chi-square test, and analysis of variance were used for statistical analysis. MAIN OUTCOME MEASURES:Prevalence of various reasons for screen failures in multiple trials and its trend among different study and patient characteristics. RESULTS:Among 87 trials and 962 patients, 465 (48.2%) patients were successfully randomized and 497 (51.8%) patients were classified as screen failures. The trials were conducted for various retinal diseases. Mean age was 76.50 ± 10.45 years and 59.4% were females. Predominantly White patients (93.4%) and unemployed/retired patients (66.6%) were screened. Of the 497 screen failures, most were because of patients not meeting inclusion criteria of imaging findings (n = 221 [44.5%]) followed by inclusion of vision-based criteria (n = 73 [14.7%]), exclusion because of other factors (n = 75 [15.1%]), patient-related (n = 34 [6.8%]), physician-related (n = 28 [5.6%]), and miscellaneous reasons (n = 39 [7.8%]). Reason for screen failure was not available for 27 (5.4%) patients. A higher proportion of patients screened for surgical trials (15%) declined to participate in the study compared with noninvasive trials involving topical drugs and photobiomodulation (0%) (P = 0.02). CONCLUSIONS:Patients not meeting the imaging and vision-cased criteria were the most common reasons for screen failures. White patients and unemployed patients predominantly participated in clinical trials. Patients are more inclined to continue participation in noninvasive clinical trials compared with surgical trials. Better recruitment strategies and careful consideration of study criteria can aid in decreasing the rate of screen failures. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.
Purpose of review Geographic atrophy (GA) from age-related macular degeneration (AMD) remains a leading cause of vision loss. The purpose of this review is to summarize currently available intravitreal therapeutics, and discuss pipeline therapeutics that are currently in clinical trials. Recent findings The FDA approval of pegcetacoplan and avacincaptad pegol, both approved in 2023, represent the first therapeutics to treat GA. These are delivered via intravitreal injections, and have been shown to slow progression of GA. Both drugs have a risk of new onset neovascular age-related macular degeneration (nAMD). Initial indications seem to be that pegcetacoplan therapy has higher risks of inflammation, vasculitis, and nonarteritic ischemic optic neuropathy (NAION) as compared to avacincaptad pegol, but more real-world data will help to clarify this further. Pipeline therapeutics that we discuss include intravitreal gene therapy, oral anticomplement therapy, and intravitreal injections of a novel glycoprotein. Summary Both pegcetacoplan and avacincaptad pegol are FDA approved to treat GA. The decision to treat patients is still complex and nuanced, but the approval of two treatments for GA is a tremendous advance in our field. Future therapeutics may further refine our ability to treat patients more effectively and safely.
PURPOSE:The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration. The United States Prescribing Information has a Boxed Warning for endophthalmitis and reports the incidence rate in patients developing endophthalmitis after receiving the PDS compared with monthly intravitreal ranibizumab. Endophthalmitis cases noted in the Boxed Warning, treatment outcomes, potential contributing factors, and potential mitigations are summarized. DESIGN:Retrospective review of endophthalmitis cases in PDS-treated patients in the phase II Ladder (NCT02510794) and phase III Archway (NCT03677934) and Portal (NCT03683251) trials. PARTICIPANTS:Endophthalmitis cases in the pooled all-PDS safety population (N = 555) including PDS patients in Ladder, Archway, or Portal. METHODS:Ladder patients received PDS (10, 40, or 100 mg/ml) with pro re nata refill-exchanges. Archway patients received PDS 100 mg/ml with fixed refill-exchanges every 24 weeks (PDS Q24W). Portal patients received PDS Q24W from day 1. MAIN OUTCOME MEASURES:Clinical features, management, and visual outcomes were summarized. Cases were summarized by date of PDS implant and/or refill, other prior invasive procedures/refills, and preceding/concurrent conjunctival complications. RESULTS:Twelve endophthalmitis events were reported in 11 patients (11/555 [2.0%]) through March 12, 2021. All were cultured (3 were culture positive) and treated with intravitreal antibiotics. Two cases (2/555 [0.4%]) occurred in the immediate postoperative period (days 5 and 6). Nine cases occurred later (day range: 57-853), including 4 before the first refill-exchange (day range: 57-161). Five patients received between 1 and 11 refill-exchanges before the event (onset: 6-168 days after last refill-exchange). Seven cases (7/11 [63.6%]) had preceding/concurrent conjunctival complications. At last follow-up, 7 patients recovered vision to study baseline levels or ≥20/40; 4 patients experienced vision loss of ≥15 ETDRS letters. CONCLUSIONS:Endophthalmitis is a serious complication that can endanger vision after any ocular procedure, including PDS implantation. Most, but not all, of this limited series of endophthalmitis cases were late onset, associated with conjunctival breach, and recovered vision with treatment. Meticulous attention to PDS surgical techniques with vigilant monitoring of conjunctiva during follow-up may minimize risk of endophthalmitis. Prompt treatment is critical for optimizing patient outcomes. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Background and Objective: To assess ocular, visual, and anatomical outcomes following the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN®) and incisional intraocular pressure (IOP)-lowering surgery in diabetic macular edema. Patients and Methods: From a 36-month, phase 4, open-label, observational study ( N = 202 eyes, 159 patients), 8 eyes (7 patients) required IOP-lowering surgery post-FAc; eyes were segregated by FAc-induced ( n = 5, 2.47%) versus neovascular glaucoma (NVG)-related ( n = 3, 1.49%) IOP elevations and assessed for IOP, best corrected visual acuity (BCVA), central subfield thickness (CST), and cup-to-disc ratio (c/d). Results: Changes at 36 months were +5.4 letters BCVA ( P > 0.05) and +0.09 c/d ( P = 0.0217); IOP and CST were unchanged. FAc-induced-group eyes required fewer IOP-lowering medications than NVG-group eyes (2.0 versus 4.0; P < 0.01) but for longer duration (15.2 versus 2.6 months; P < 0.001). Conclusions: Post-FAc IOP-lowering surgery, regardless of cause, largely did not affect the outcomes measured; these procedures, then, may not meaningfully threaten positive outcomes. [ Ophthalmic Surg Lasers Imaging Retina 2024;55:22–29.]
BACKGROUND AND OBJECTIVE:A consensus exercise was carried out to address unmet needs in the classification, diagnosis, and management of patients with chronic noninfectious uveitis affecting the posterior segment (NIU-PS), with a focus on chronic postoperative inflammation/cystoid macular edema. METHODS:Eight experts participated in roundtable discussions and consensus-building exercises to develop clear guidelines for the diagnosis and management of chronic NIU-PS. The group addressed questions surrounding clinical features, diagnostic tests, and treatment considerations. RESULTS:Clinicians agreed that chronic uveitis/intraocular inflammation should be defined as having persistence or recurrence for 3 or more months. Diagnosis is informed by evaluation of signs and symptoms, use of imaging, and exclusion of infectious etiologies. Management should be initiated with the least invasive therapies, proceeding to intraocular injections, and/or long-term intravitreal or systemic therapies, as necessary. CONCLUSION:This article offers an up-to-date consensus guideline based on clinical experience. Future clinical trials may help to test and reevaluate these recommendations. [Ophthalmic Surg Lasers Imaging Retina 2024;55:652-658.].
Abstract Introduction Uncontrolled non-infectious uveitis affecting the posterior segment (NIU-PS) can lead to vision loss due to repeated bouts of inflammation and consequent tissue damage. Patients with chronic NIU-PS who experience recurrent uveitis after being treated with systemic and short-acting local corticosteroids may benefit from the sustained-release 0.18-mg fluocinolone acetonide implant (FAi). Methods In this case series, 18 eyes with chronic, recurrent NIU-PS and cystoid macular edema (CME) treated with the 0.18-mg FAi were analyzed retrospectively. Data on patient demographics, clinical history, previous and concomitant treatments for uveitis recurrence, time to and number of uveitis recurrences, intraocular pressure (IOP), central subfield thickness (CST), and visual acuity (VA) were collected and summarized. Results A majority of patients (14/15 [93%]) had a history of ocular surgery, largely cataract extraction, and all developed chronic and recurrent NIU-PS and CME. At baseline, patients had a mean age of 72 years (range: 46 to 93), were 53% male, and had a mean duration of NIU-PS of 3 years (range: 1 to 19). Patients were followed for an average of 16.5 months (range: 2 to 42.5 months) post FAi. Eleven of the 18 eyes (61%) had ≥ 5 recurrences of uveitis since diagnosis, with an average time to recurrence of approximately 12 weeks (range: 1 to 27). All eyes treated with the 0.18-mg FAi showed reduced NIU-PS recurrence and visual and anatomical improvement, as measured by VA and CST, respectively. Two eyes had an IOP elevation that was managed with topical therapy, and one eye was treated with topical prednisolone for additional inflammation management. Two eyes required adjunct therapy with short-acting intravitreal corticosteroids at 7 and 16 weeks for NIU-PS recurrence after 0.18-mg FAi insertion. Conclusion After receiving the 0.18-mg FAi, eyes with uncontrolled NIU-PS had sustained resolution of CME and inflammation with limited need for supplementary steroid drops or injections and minimal steroid class-specific adverse effects; none required incisional IOP-lowering surgery.