Abdurrahman Sarmis, Omer Faruk Yilmaz, Muhammed Ali Mutlu, Serap Karaca, Deniz Turan, Halit Oguz
{"title":"Assessment of Bacterial and Fungal Contamination in Preservative-Free Multi-Dose Cyclosporine Eye Drops.","authors":"Abdurrahman Sarmis, Omer Faruk Yilmaz, Muhammed Ali Mutlu, Serap Karaca, Deniz Turan, Halit Oguz","doi":"10.1177/10807683251363844","DOIUrl":"https://doi.org/10.1177/10807683251363844","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> This study investigated the bacterial and fungal contamination of preservative-free, multidose cyclosporine (PFMD-Cyc) bottles. <b><i>Methods:</i></b> One hundred PFMD-Cyc eye drops administered by different patients for a minimum of 3 weeks were analyzed. The caps and first and second drops from the bottles underwent microbiological testing using sheep blood agar, chocolate agar, Sabouraud dextrose agar, and <i>Brucella</i> broth media. Conjunctival cultures were obtained from patients whose bottles were contaminated. The residual drug inside the contaminated bottles was examined by drilling the bottles' underside. <b><i>Results:</i></b> Microbial contamination was detected in 47% (<i>n</i> = 47) of the samples, with both poly- and monomicrobial growth. Fifty-nine species (25 gram-positive and 11 gram-negative bacteria, 15 yeasts, and 8 molds) were identified in the contaminated bottles. The most prevalent microorganisms were <i>Staphylococcus epidermidis</i> (<i>n</i> = 11), <i>Candida parapsilosis</i> (<i>n</i> = 7), and <i>Fusarium</i> spp. (<i>n</i> = 4). Conjunctival cultures from 4 patients revealed the same pathogens identified in the contaminated bottle, including <i>Serratia marcescens, Klebsiella aerogenes, Staphylococcus aureus,</i> and <i>Candida parapsilosis</i>. <b><i>Conclusions:</i></b> In addition to bacteria, a particularly high level of fungal contamination was detected. Conjunctival microorganisms were also detected in select samples. Patients should be advised to practice proper hand hygiene before administering eye drops. Moreover, meticulous attention to the storage conditions of medications during treatment is essential. Furthermore, research into fungal contamination of ophthalmical solutions, particularly immunosuppressive eye drops, is warranted.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144746865","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hanne Herbots, Luc Van Os, William Aerts, Marie-José Tassignon, Adrian Covaci, Catalina Dumitrascu, Vera Saldien
{"title":"Evaluation of Systemic Exposure to Intracameral Tropicamide 0.02%, Phenylephrine 0.31%, and Lidocaine 1% in Pediatric Cataract Surgery.","authors":"Hanne Herbots, Luc Van Os, William Aerts, Marie-José Tassignon, Adrian Covaci, Catalina Dumitrascu, Vera Saldien","doi":"10.1177/10807683251359451","DOIUrl":"https://doi.org/10.1177/10807683251359451","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> Pediatric cataract surgery requires mydriasis, typically achieved with eye drops. An intracameral mydriatic combining tropicamide 0.02%, phenylephrine 0.31%, and lidocaine 1% is established in adults, but not in children. We aimed to evaluate the safety profile of this intracameral mydriatic in children. <b><i>Methods:</i></b> We conducted a prospective observational cohort study on 40 patients, aged 8 weeks to 17 years, undergoing cataract surgery under general anesthesia (GA) and receiving 1 intracameral injection (0.1 mL) of the mydriatic. Thirteen patients underwent immediate sequential bilateral cataract surgery with a second injection to the second eye. We evaluated the incidence of hemodynamic adverse effects and assessed systemic exposure by quantification of plasma concentrations of phenylephrine and tropicamide at 4 fixed time points during the procedure. <b><i>Results:</i></b> The highest plasma concentrations of phenylephrine and tropicamide were detected in the youngest patients (age 8 weeks-1 year), with a significant increase from baseline (<i>P</i> = 0.008 and <i>P</i> = 0.023, respectively). In patients aged 1-6 years, significant changes were observed only in the plasma concentration of phenylephrine (<i>P</i> < 0.001). For patients aged 6-17 years, there was no significant rise in phenylephrine nor in tropicamide plasma concentration (<i>P</i> = 0.194 and <i>P</i> = 1.000). No clinically important changes in hemodynamic parameters occurred in any age group. Sequential bilateral administration did not result in an increase in plasma concentrations, nor in an increase of hemodynamic adverse effects. <b><i>Conclusions:</i></b> Intracameral mydriatic injection did not induce cardiovascular adverse events, and systemic exposure was minimal in this pediatric population undergoing cataract surgery under GA.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144669275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jie Zhou, Danping Wang, Gao Chun Li, Qinzhu Huang, Ledan Wang, Wenjuan Huang, Zhenyang Xiang, Yongyong Fan
{"title":"GCN5-TFEB Pathway Regulates Inflammation by Tuning Autophagic Degradation of Retinoic Acid-Induced Gene-I in Human Conjunctival Epithelial Cells.","authors":"Jie Zhou, Danping Wang, Gao Chun Li, Qinzhu Huang, Ledan Wang, Wenjuan Huang, Zhenyang Xiang, Yongyong Fan","doi":"10.1089/jop.2025.0029","DOIUrl":"https://doi.org/10.1089/jop.2025.0029","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> To evaluate the pathological role of the GCN5-TFEB axis in dry eye diseases (DEDs) by detecting the autophagic degradation of retinoic acid-inducible gene I (RIG-I), a master RNA-sensing receptor in cells. <b><i>Methods:</i></b> RNA-sequencing analysis and quantitative PCR (qPCR) analysis of the expression level of genes related to the interferon (IFN)-I signaling pathway was used to evaluate the inflammatory level of cells overexpressed with General control non-repressed protein 5 (GCN5) or empty vector, which were further confirmed by Western Blot (WB) analysis. siRNA and chemical treatment were used to inhibit GCN5. The acetylation level of transcription factor EB (TFEB) was detected by WB, and qPCR analysis confirmed the transcriptional activity of TFEB. Immunofluorescence and WB were used to measure autophagy and lysosomal biogenesis. When the GCN5 activity was regulated, the autophagic degradation of RIG-I and its pathological role in DEDs were determined by detecting the protein level of RIG-I and the level of cell inflammation. <b><i>Results:</i></b> Cells that overexpressed GCN5 showed increased expression of genes involved in the IFN-I signaling pathway compared with cells transfected with an empty vector. Inhibition of GCN5 decreased the acetylation level of TFEB and increased the transcriptional activity of TFEB, combined with the elevated autophagy and lysosomal biogenesis in human corneal epithelial cells (HCECs). Promoting the autophagic degradation of RIG-I by GCN5 inhibition could alleviate the IFN-I signaling pathway. <b><i>Conclusions:</i></b> GCN5 could aggravate the activity of the IFN-I signaling pathway in HCECs by acetylating TFEB and inhibiting autophagy, which caused the accumulation of RIG-I. This process could be used to control the overactivation of inflammation in the pathological development of DED.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144593779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Na Sun, Xu Hu, Jianhui Wang, Tengteng Yao, Zhaoyang Wang
{"title":"Minichromosome Maintenance Complex Genes Are Candidate Biomarkers of Retinal Degeneration.","authors":"Na Sun, Xu Hu, Jianhui Wang, Tengteng Yao, Zhaoyang Wang","doi":"10.1089/jop.2025.0047","DOIUrl":"https://doi.org/10.1089/jop.2025.0047","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> Retinal degeneration is the primary cause of blindness and is characterized by progressive dysfunction and death of retinal cells, leading to irreversible vision impairment. As far as is known, there are currently no effective treatments for this condition. The identification of novel therapeutic targets remains a critical challenge. <b><i>Methods:</i></b> To address this vital issue, we performed an in-depth transcriptome analysis of the sodium iodate-induced cell model (NaIO<sub>3</sub>-treated cells), further identified the differential gene expression and common pathways, performed enrichment analysis, constructed protein-protein interaction (PPI) networks, and screened for three core DNA replication-related genes (<i>MCM4</i>, <i>MCM5</i>, and <i>MCM7</i>). Subsequently, quantitative real-time polymerase chain reaction (qPCR) and immunohistochemistry assays were performed to verify the expression levels of hub genes in the NaIO<sub>3</sub>-treated adult retinal pigment epithelial cell line-19 and animal models. <b><i>Results:</i></b> The pathways were mainly focused on DNA replication in the enrichment analysis. PPI network analysis revealed that minichromosome maintenance complex genes associated with DNA replication were core genes for retinal degeneration. qPCR and immunohistochemistry assays showed that the expression levels of hub genes were downregulated in the NaIO<sub>3</sub>-treated cell and animal models. <b><i>Conclusions:</i></b> Collectively, our bioinformatics analysis, coupled with experimental validation, identified three core DNA replication-related genes (<i>MCM4</i>, <i>MCM5</i>, and <i>MCM7</i>) with potential implications in retinal degeneration, suggesting their roles in the disease process. These findings shed light on the molecular underpinnings of retinal degeneration and pave the way for the development of targeted therapies aimed at modulating DNA replication-related gene activity to treat retinal degeneration.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144510283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Exploring the Efficacy of AZD6738 in Corneal Neovascularization: Autophagy Enhancement and Angiogenesis Inhibition.","authors":"Qing Wang, Yangyang Peng, Shuna Wang, Jingjing Xu, Chiwen Cheng, Xiao Luo, Kang Yu, Wen Yao, Yijie Pi, Zeyu Zhu, Yifeng Yu","doi":"10.1089/jop.2024.0162","DOIUrl":"https://doi.org/10.1089/jop.2024.0162","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> This study aimed to investigate the therapeutic potential of AZD6738, an ataxia-telangiectasia and rad3-related (ATR) kinase inhibitor, in preventing corneal neovascularization (CNV) by exploring its effects on autophagy regulation and angiogenesis. <b><i>Methods:</i></b> Human umbilical vein endothelial cells were cultured and treated with varying concentrations of AZD6738 and vascular endothelial growth factor (VEGF) to assess cell viability, migration, and tube formation. A corneal alkali burn model in Sprague-Dawley rats was established to evaluate the <i>in vivo</i> effects of AZD6738 on CNV. Autophagy was assessed using monodansylcadaverine (MDC) staining, western blotting, and qRT-PCR to measure the expression of autophagy-related markers and key proteins involved in the PI3K-AKT pathway. Immunohistochemistry and immunofluorescence staining were employed to examine histological changes and the expression of markers related to neovascularization and fibrosis. <b><i>Results:</i></b> The study demonstrated that AZD6738 significantly inhibited cell viability in a dose-dependent manner. AZD6738 effectively reduced VEGF-induced cell migration and tube formation. Moreover, the introduction of AZD6738 enhanced autophagy, as indicated by increased MDC staining, upregulated Beclin1 expression, and an elevated LC3 II/I ratio. The inhibitor also suppressed the PI3K-AKT pathway, reducing VEGF and VEGFR2 expression, and decreasing the phosphorylation levels of AMPK and AKT. In an experimental CNV model, AZD6738 treatment resulted in a significant reduction in CNV, with fewer and shorter blood vessels observed, as well as changes in autophagy-related proteins. <b><i>Conclusions:</i></b> AZD6738 showed potential in preventing CNV. Its ability to enhance autophagy and inhibit PI3K-AKT-VEGF pathways in angiogenesis suggests that AZD6738 could be an effective treatment strategy for CNV.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144510282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Eyes on New Product Development.","authors":"Gary D Novack","doi":"10.1089/jop.2025.0130","DOIUrl":"https://doi.org/10.1089/jop.2025.0130","url":null,"abstract":"","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chula Srikajorn, Waree Tiyaboonchai, Sangly P Srinivas, Wanachat Thongsuk
{"title":"Mucoadhesive Silk Fibroin Nanoparticles for Drug Delivery to the Ocular Surface.","authors":"Chula Srikajorn, Waree Tiyaboonchai, Sangly P Srinivas, Wanachat Thongsuk","doi":"10.1089/jop.2024.0180","DOIUrl":"https://doi.org/10.1089/jop.2024.0180","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> To develop silk fibroin nanoparticles (SFNs) for prolonged drug delivery to the ocular surface. <b><i>Methods:</i></b> SFNs were prepared using nanoprecipitation, coated with chitosan (CS; positively charged), and stabilized with polyethylene glycol 400. Their morphology, particle size distribution, and surface charge were analyzed using dynamic light scattering. Fourier transform infrared (FTIR) spectroscopy assessed the intermolecular interactions between CS and silk fibroin. The entrapment efficiencies (EE) for sodium fluorescein (NaF) and Nile Red (NR), which served as hydrophilic and hydrophobic drug surrogates, respectively, were determined. The mucoadhesiveness of SFNs was examined <i>ex vivo</i> with freshly isolated porcine eyes. Cellular uptake and cytotoxicity were evaluated in a human corneal epithelium cell line (HCEC). <b><i>Results:</i></b> SFNs were spherical, measuring 198.47 ± 35.54 nm in diameter, and had a surface charge of 38.33 ± 0.67 mV. The coating of CS on SFNs resulted in a peak shift in the amide group in the FTIR spectrum. The maximum EEs for NaF and NR in SFNs were approximately 95% and 67%, respectively. SFNs exhibited prolonged mucoadhesion on corneas for over 240 min and were rapidly endocytosed by HCEC in less than 30 min without inducing cytotoxicity. <b><i>Conclusion:</i></b> The properties of SFNs are suitable for delivering drugs to the ocular surface.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tear Pharmacokinetics and Systemic Exposure of Dexamethasone Canalicular Inserts in Rabbits.","authors":"Minsun Moon, Jihyun Won, Wonku Kang","doi":"10.1089/jop.2025.0082","DOIUrl":"https://doi.org/10.1089/jop.2025.0082","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> A dexamethasone canalicular insert, Dextenza®, has been used to treat anterior inflammation of the eye, including keratoconjunctivitis sicca. This study aimed to investigate the tear pharmacokinetics and systemic exposure of dexamethasone in New Zealand White rabbits after inserting the preparation into the punctum and to correlate the data with the <i>in vitro</i> dissolution test. <b><i>Methods:</i></b> Dextenza was inserted into the punctum of rabbits. A paper strip serially collected tears, and dexamethasone concentrations in tears and plasma were measured using HPLC-MS/MS. The time courses of tear and plasma dexamethasone concentrations were characterized. <b><i>Results:</i></b> The release of dexamethasone from the insert to tears in rabbits was completed in ∼ 5 days, much faster than in humans and dogs (30 days). The time course of plasma dexamethasone concentration was fully characterized, in contrast to the fact that systemic exposure was merely observed in the other species. The present results might be attributed to the anatomical structure of the lacrimal sac beneath rabbits' canaliculi. The <i>in vitro</i> dissolution pattern represented an excellent correlation with the <i>in vivo</i> release in tears. <b><i>Conclusions:</i></b> We first examined the pharmacokinetic study of the canalicular insert in rabbits, which could be applied to the other insert studies in the species.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sonja Krösser, Ralf Grillenberger, Kirsten Eickhoff, Johannes Korward, Megan E Cavet, Francis S Mah
{"title":"Ocular Pharmacokinetics and Biodistribution of Perfluorohexyloctane after Topical Administration to Rabbits.","authors":"Sonja Krösser, Ralf Grillenberger, Kirsten Eickhoff, Johannes Korward, Megan E Cavet, Francis S Mah","doi":"10.1089/jop.2025.0056","DOIUrl":"https://doi.org/10.1089/jop.2025.0056","url":null,"abstract":"<p><p><b><i>Purpose:</i></b> Perfluorohexyloctane ophthalmical solution (PFHO) forms an anti-evaporative layer at the air-tear interface and is indicated for treatment of the signs and symptoms of dry eye disease (DED). This study evaluated the ocular pharmacokinetics and biodistribution of PFHO in rabbits. <b><i>Methods:</i></b> Radiolabeled PFHO was administered to female Dutch Belted rabbits as single (35 µL to each eye) or multiple (twice daily for 5 days) topical ocular doses. Animals were euthanized at designated timepoints. Tears (antemortem), ocular tissues, and blood were collected for pharmacokinetic analysis; heads and carcasses were collected for autoradiographic analysis. Concentrations were measured using liquid scintillation counting. <b><i>Results:</i></b> After multiple doses, maximum concentration (C<sub>max</sub>) and area under the concentration-time curve were highest in tears (2330 µg/g, 3720 µg•h/g) and Meibomian glands (222 µg/g, 1440 µg•h/g), followed by other anterior tissues (cornea, 27.6 µg/g, 463 µg•h/g; palpebral conjunctiva, 14.0 µg/g, 136 µg•h/g). PFHO was measurable in tears for 8 h and in Meibomian glands for ≥24 h. Distribution to the posterior ocular segment was minimal, and plasma concentrations were low (single-dose C<sub>max</sub>, 0.97 µg/g; multiple-dose C<sub>max</sub>, 3.2 µg/g). In non-ocular tissues, PFHO was confined primarily to nasal tissues and gastrointestinal tract contents; exposure to other systemic tissues was negligible. <b><i>Conclusions:</i></b> Exposure of PFHO was highest in tears, consistent with its anti-evaporative mode of action, followed by the Meibomian glands. PFHO exposure was very low in posterior ocular tissues and negligible in systemic circulation, consistent with the clinical safety profile.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144328445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical Trials of Aflibercept Biosimilars: A Review.","authors":"HyunWoo Lee, Ashish Sharma, Se Joon Woo","doi":"10.1089/jop.2025.0040","DOIUrl":"https://doi.org/10.1089/jop.2025.0040","url":null,"abstract":"<p><p>Anti-vascular endothelial growth factor (VEGF) biologics have revolutionized the management of VEGF-driven retinal diseases, significantly improving visual outcomes for patients. Following the patent expiration of ranibizumab, multiple anti-VEGF biosimilars have been developed, with the first approved for ophthalmic use entering the market in 2022. More recently, the expiration of aflibercept market exclusivity in 2024 has led to the rapid development of aflibercept biosimilars-some already approved and others pending regulatory decisions. By offering clinically equivalent and cost-effective alternatives to reference biologics, biosimilars can lessen financial burdens and improve treatment adherence. Understanding the study designs of biosimilars can mitigate negative perceptions of biosimilars and promote their active implementation. In this review, we provide a comprehensive comparison of the designs of phase III clinical trials of aflibercept biosimilars, including recently published results.</p>","PeriodicalId":520681,"journal":{"name":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144319187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}