Fluocinolone acetonide 0.025% / Clioquinol 3% ointment

This systematic review evaluates the real-world efficacy and safety of the 0.19 mg fluocinolone acetonide (FAc) sustained-release intravitreal implant for treating non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). Following PRISMA guidelines, a search was conducted in PubMed, Embase and Web of Science, with the latest update on September 20, 2024. Twelve real-world studies involving a total of 382 patients (514 eyes) were included in the review. Compared to baseline, the studies consistently showed reduced mean central retinal thickness for up to 36 months post-FAc implantation, while mean visual acuity was stable or significantly improved. Intraocular inflammation, as per the Standardization of Uveitis Nomenclature grading system, was persistently absent or improved, with evidence extending to 12 months following implantation. While FAc generally showed potential to reduce or maintain systemic immunosuppressive treatments, this effect was not consistently observed, particularly in cases involving choroidal inflammation. Local rescue treatment was used in up to 24% of eyes. Mean intraocular pressure remained stable for 36 months with up to 38.5% of eyes requiring either supplemental or initial IOP-lowering medication. Limited data was available on cataract development. A few cases of hypotony as well as one case of retinal detachment were observed. Overall, current real-world evidence aligns with clinical trial findings, suggesting that the 0.19 mg FAc implant is an effective adjunctive maintenance treatment for NIU-PS with a consistent safety profile. Further studies are needed to refine treatment guidelines.

Abstract licence: CC BY

Background/Objectives: The fluocinolone acetonide implant (FAI) is an intravitreal corticosteroid implant designed to have a therapeutic effect lasting up to 3 years. We performed a meta-analysis to investigate the efficacy and safety of the FAI (0.19 mg, releasing at 0.2 μg/day) in patients with non-infectious uveitis. Methods: The PubMed, EMBASE, and Cochrane Library databases were last searched on 6 September 2024. Studies comparing FAI with sham injections were investigated. The primary outcome was the recurrence of uveitis. Secondary outcomes included visual acuity, intraocular pressure (IOP), and occurrence of cataracts. Results: Significantly more patients in the FAI group experienced no uveitis recurrence for up to 36 months compared to the sham group, with a relatively lower number of recurrences. Systemic adjuvant therapy was similar between groups, while fewer patients required local rescue injections in the FAI group (95% confidence interval (CI): −2.91 to −1.70). Visual acuity changes and the proportion of eyes with ≥15 letters gain were not significantly different between the groups. More patients needed cataract surgery in the FAI group (95% CI: 0.68–1.96). No differences were observed in IOP change, final IOP, or treatment-requiring events related to an increased IOP. However, more subjects experienced events of IOP > 25 mmHg with the FAI (95% CI: 0.73 to 2.14). Conclusions: The 0.19 mg FAI was effective in preventing uveitis recurrence, and reduced the need for local injections. No significant impacts were noted in terms of systemic therapy, visual improvement, or most IOP-related complications.

Abstract licence: CC BY

BACKGROUND: Treatment with fluocinolone acetonide, hydroquinone, and tretinoin cream is the gold standard for melasma; however, the effects of this treatment in the Chinese population remain unclear. Due to the differences between Chinese and Caucasian subjects, further clinical trials in Chinese patients with melasma are needed. AIM: To evaluate the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin creams in Chinese patients with moderate-to-severe melasma. METHODS: We recruited 53 patients who received a generic formulation (triple combination cream, TCC), brand formulation (TRI-LUMA), or placebo once daily for 8 weeks. In weeks 4 and 8, efficacy was evaluated based on the Melasma Severity Scale and Melasma Area and Severity Index. In addition, safety was assessed based on the incidence and severity of treatment-emergent adverse events. RESULTS: The generic TCC group achieved 52.2% efficacy compared to 57.1% in the TRI-LUMA group. There was no significant difference in the incidence of adverse effects between the TCC and TRI-LUMA groups (69.6% and 90.5%, respectively; p > 0.05). The incidence of adverse events in the placebo group was 0%. CONCLUSION: Generic TCC was as effective as TRI-LUMA and had a similar safety profile in this study of Chinese subjects with moderate-to-severe melasma.

Abstract licence: CC BY

BACKGROUND: Non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) is an inflammatory disease, which can significantly impair visual acuity if not adequately treated. Fluocinolone-acetonide sustained-release-0.2 µg/day intravitreal (FAc) implants are indicated for prevention of relapse in recurrent NIU-PS. The aim here was to provide treating clinicians with some consensus-based-recommendations for the clinical management of patients with NIU-PS with 0.2 µg/day FAc implants. METHODS: A European-clinical-expert-group agreed to develop a consensus report on different issues related to the use of FAc implants in patients with NIU-PS. RESULTS: The Clinical-expert-panel provided specific recommendations focusing on clinical presentation (unilateral/bilateral) of the NIU-PS; systemic involvement of NIU-PS and the lens status. Treatment algorithms were developed; one that refers to the management of patients with NIU-PS in clinical practice and another that establishes the best clinical scenarios for the use of FAc implants, both as monotherapy and as adjuvant therapy. Additionally, the Clinical-expert-panel has provided recommendations about the use of the FAc implants in a clinical-setting. The Clinical-expert-panel also considered the safety profile of FAc implants and their possible implications in the daily practice. CONCLUSIONS: As more clinical experience has been gained using FAc implants, it was necessary to update the clinical recommendations that guide patient management in the clinic. The current consensus document addresses relevant issues related to the use of FAc implants on different types of patients with various etiologies of NIU-PS, and was conducted to standardize approaches to help specialists obtain better clinical outcomes.

Abstract licence: CC BY

Diabetic macular edema (DME) is a common complication of diabetic retinopathy. Treatment with intravitreal injections is effective in most cases but is associated with a high therapeutic burden for patients. This implies the need for long-term treatments, such as the fluocinolone acetonide (FAc) implant. A review of basic science, pharmacology, and clinical data was conducted to provide a state-of-the-art view of the FAc implant in 2024. Although generally well tolerated, the FAc implant has been associated with ocular hypertension and cataract, and caution should be advised to the patients in this regard. By synthesizing information across these domains, a comprehensive evaluation can be attained, facilitating informed decision-making regarding the use of the FAc implant in the management of DME. The main objective of this review is to provide clinicians with guidelines on how to introduce and use the FAc implant in a patient with DME.

Abstract licence: CC BY

Diabetic macular oedema [DMO] is a prevalent and sight-threatening condition among diabetic patients, which can cause irreversible blindness. Since angiogenesis and inflammation are two key elements in the etiopathogenesis of DMO, intravitreal injections of vascular endothelial growth factor inhibitors [anti-VEGF] and sustained released intravitreal corticosteroid implants are currently considered as treatments of choice. The introduction, 10 years ago, of the 0.19 mg fluocinolone acetonide [FAc] implant for treating eyes with vision impairment associated with recurrent and persistent DMO represented an important advance. Since then, two randomized-control trials and many real-world studies have shown its good efficacy/safety profile and the replicability of its treatment regimen. The FAc implant is, in general terms well tolerated, although it is associated with intraocular pressure-[IOP] and cataract-related adverse events [AEs]. Most IOP-related AEs are effectively controlled with ocular-hypotensive therapies. The objective of this paper is to review the role of FAc implant in the treatment of DMO over the 10 years since its launch, as well as its impact on clinical practice outcomes.

Abstract licence: CC BY

Abstract Purpose This study aimed to develop a transdermal delivery system for fluocinolone acetonide (FLA), a corticosteroid used in treating inflammatory conditions like rheumatoid arthritis (RA), to overcome the limitations of oral administration, such as poor solubility and bioavailability. Methods FLA-loaded PEG decorated hyalurosomes (FLA-PHs) were fabricated using ethanol injection, incorporating various Brij® surfactants and different amounts of hyaluronic acid (HA) based on a full factorial design. The impact of independent variables, HA amount (mg) (X 1 ) and Brij type (X 2 ) were inspected for entrapment efficiency (EE%), particle size (PS), and zeta potential (ZP). The optimum FLA-PHs were then incorporated into ε-polycaprolactone (PCL) and cellulose acetate (CA) nanofibers to enhance sustained transdermal delivery (FLA-NFs). Results The optimum FLA-PHs exhibited EE% of 83.58 ± 0.69%, PS of 169.00 ± 1.41 nm, and ZP of -22.90 ± 0.14 mV. Morphological assessment of FLA-NFs showed promising results in terms of surface roughness. In a Freund-induced rat model of adjuvant-induced arthritis, transdermal treatment with FLA-NFs significantly improved joint histopathological analyses. Furthermore, it suppressed inflammatory markers such as mTORC1, TNF-α, and NF-κB while upregulating TRIM24 and the anti-inflammatory IL-10. Conclusion FLA-NFs present a promising strategy for enhancing the transdermal delivery of FLA for managing RA, offering potential improvements in efficacy and reduced systemic side effects compared to conventional oral administration.

Abstract licence: CC BY

Purpose: To evaluate the safety and efficacy of the fluocinolone acetonide implant (FAi, Iluvien® Horus pharma, Nice, France) in non-infectious uveitic macular edema (UME) and to approach the predictive factors of treatment response. Methods: This retrospective, multicenter real-life study included patients with chronic non-infectious UME who received intravitreal FAi after at least two dexamethasone implants (DEXi). Results: Twenty-six eyes from 22 patients (73.1% of females) were included. The mean age was 60.4 ± 16 years. The mean follow-up was 11.4 ± 2 months. The mean baseline best-corrected visual acuity (BCVA) was 0.43 ± 0.36 LogMAR, improving significantly after 1, 3, 6 and 12 months (all p < 0.05 vs. baseline). The mean baseline central macular thickness (CMT) was 429 ± 110 μm, improving significantly after 1, 3, 6 and 12 months (all p < 0.05 vs. baseline). Five eyes (19.2%) developed ocular hypertension during the follow-up, requiring initiation or strengthening of intraocular pressure lowering medication. The majority of eyes (77%) did not require any rescue DEXi during the available 12-month follow-up. The resolution of UME after DEXi seemed to predict the anatomical response after FAi. The baseline presence of a disorganization of the inner retinal layers (DRIL) and hyperreflective foci (HRF) were both associated with a higher likelihood of requiring rescue DEXi injections. Conclusion: FAi implantation led to a significant BCVA and CMT improvement with a good safety profile over the 12-month follow-up. Predictive factors of treatment outcomes seem to include the anatomical response to DEXi and the presence of DRIL and HRF at baseline.

Abstract licence: CC BY