loteprednol etabonate / Generic mfg. - LARVOL DELTA

Effect of Immunosuppressive Drugs on Glucose-Stimulated Insulin Secretion: Concentration-Response Studies in Dynamic Perifusion Assays. (PubMed, bioRxiv) - "The effect on the time-profile of GSIS has been assessed over a wide concentration range for several clinically relevant immunomodulatory therapies, including small-molecule drugs (cyclosporine, sirolimus, tacrolimus, prednisolone acetate, and loteprednol etabonate) and biologics (abatacept and anti-CD40L), plus a prospective β-cell proliferation-inducing agent (harmine). Their inhibitory effect only increased slowly with concentration and did not follow a classic sigmoid pattern that has unity Hill slope. These findings establish quantitative benchmarks for immunosuppressant-induced β-cell toxicity and provide a framework for optimizing immunosuppressive regimens to reduce the risk of PTDM."

Journal • Diabetes • Metabolic Disorders • Transplantation • CD40LG

Evaluating Lacrimal Punctum Size as a Clinical Indicator of Dry Eye Disease Severity in a Real-World Lebanese Cohort. (PubMed, J Clin Med) - "A total of 312 eyes from 156 patients with moderate-to-severe DED unresponsive to topical artificial tears, loteprednol etabonate, and cyclosporine (0.05% ophthalmic emulsion) were included...These findings suggest that lacrimal punctal diameter estimation during therapeutic plug insertion may serve as a practical, cost-free adjunct to standard DED evaluation. Prospective multimodal studies are needed to validate punctal diameter as an independent clinical indicator of DED severity."

Journal • Real-world evidence • Dry Eye Disease • Ophthalmology

A case of microsporidial keratoconjunctivitis (PubMed, Zhonghua Yan Ke Za Zhi) - "Initially diagnosed as bilateral Thygeson superficial punctate keratitis, he was treated with 0.5% loteprednol etabonate suspension eye drops and other medications...The treatment regimen was adjusted to topical application of 1% voriconazole eye drops, 0.3% gatifloxacin ophthalmic gel, and 0.1% tacrolimus eye drops...One month after treatment, his symptoms were basically relieved, with the corneal infiltration and palpebral conjunctival papillae resolved. No recurrence was observed during the one-year follow-up."

Journal • Conjunctivitis • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Effects of Topical Steroids and Non-Steroidal Anti-Inflammatory Drugs on Gastrointestinal Bleeding in Rats. (PubMed, Vet Med Sci) - "Short-term topical ocular steroid and NSAID treatments were not associated with statistically significant systemic gastrointestinal alterations under the conditions of this study."

Journal • Preclinical • Gastroenterology

Loteprednol etabonate nanostructured lipid carriers for enhanced ocular bioavailability. (PubMed, Colloids Surf B Biointerfaces) - "All formulations were non-irritant (HET-CAM), biocompatible, and maintained > 80% cell viability. Overall, the present work introduces a very promising LTP-NLC platform with demonstrated superiority over existing therapies, offering a strategy for enhancing ocular drug delivery, reducing dosing burden, and improving patient outcomes."

Journal • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas (clinicaltrials.gov) - P4 | N=66 | Completed | Sponsor: Fayoum University

New P4 trial • Ocular Inflammation • Ophthalmology • Uveitis

Postoperative Corneal Dellen Following PreserFlo MicroShunt: A Case Report. (PubMed, Am J Case Rep) - "Conservative therapy, including a switch from prednisolone acetate to loteprednol etabonate, intensive preservative-free lubrication, autologous serum drops, and bandage contact lens placement, was initiated...Prompt recognition and targeted conservative therapy may allow for complete recovery while preserving device function and visual outcomes. Surgeons should monitor the ocular surface for this complication and adjust postoperative management accordingly."

Journal • Glaucoma • Ophthalmology

Alembic Pharmaceuticals Ltd… said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection. (The Hindu Business Line) - "The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing...Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added."

ANDA • Infectious Disease • Ocular Inflammation

Different formulations of corticosteroid eye drops at different treatment times in the control of inflammation and prevention of cystoid macular edema after cataract surgery: randomized clinical trial. (PubMed, Arq Bras Oftalmol) - "Equivalent postoperative inflammation control can be achieved using different corticosteroid eye drop formulations at varying treatment durations following cataract surgery. Brazilian Registry of Clinical Trials (ReBEC): RBR-2frpntv."

Clinical • Journal • Cataract • Inflammation • Macular Degeneration • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain (clinicaltrials.gov) - P=N/A | N=64 | Completed | Sponsor: Virginia Polytechnic Institute and State University | Recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Pain • Retinal Disorders

Efficacy and Safety of Loteprednol Etabonate in Managing Pain and Inflammation After Cataract Surgery: A Systematic Review and Meta-analysis. (PubMed, Eye Contact Lens) - "Loteprednol etabonate demonstrates significant efficacy in alleviating pain and inflammation post-cataract surgery, with notable advantages in safety, including minimal impact on intraocular pressure and reduced adverse events."

Journal • Retrospective data • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain

Which topical ophthalmic drugs work best for Keratoconjunctivitis Sicca? A systematic review and meta-analysis. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The study concluded that cyclosporine therapy offers improvements in corneal fluorescein staining but does not significantly affect other common DED symptoms, such as OSDI, TBUT, and Schirmer test scores. Similarly, no significant improvements in DED symptoms were observed with loteprednol etabonate or diquafosol sodium. Further research is needed to explore the efficacy of these treatments in managing DED symptoms more comprehensively."

Journal • Retrospective data • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

PCR-Based Evaluation of Viral Load Reduction in Adenoviral Conjunctivitis: A Comparative Study of Ganciclovir and Povidone-Iodine. (PubMed, Ocul Immunol Inflamm) - "To evaluate the efficacy of topical ganciclovir (GCV), povidone-iodine (PVP-I), and their combination with loteprednol etabonate (LE) in reducing viral load and improving clinical outcomes in adenoviral conjunctivitis. PVP-I significantly decreased viral load in the early phase, while PVP-I/LE and GCV/LE combinations led to faster clinical improvement. Subepithelial infiltrates were significantly lower in the PVP-I/LE group, suggesting this combination may help prevent complications and offer an effective treatment option."

Journal • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology

Mucoadhesive Micellar Eyedrops for the Treatment of Ocular Inflammation. (PubMed, Acta Biomater) - "Commercial eyedrops, like Oceanside® (0.5% loteprednol etabonate (LE) ophthalmic suspension), suffer from low ocular bioavailability and require frequent dosing to maintain therapeutic levels...These micelles showed high PBA conjugation efficiency (>67%), a 12-day sustained release of LE, strong mucin adhesion, in vitro and in vivo biocompatibility. In a mouse model of corneal inflammation, a once-daily LE-loaded micellar eyedrop matched the efficacy of the commercial LE eyedrop (Oceanside®, 0.5%), which is dosed four times daily, reducing corneal opacity, preserving corneal structure, and decreasing inflammation."

Journal • Inflammation • Keratitis • Ocular Inflammation • Ophthalmology

Childhood-onset ocular mucous membrane pemphigoid presenting with peripheral ulcerative keratitis: a case report and review of the literature. (PubMed, J Ophthalmic Inflamm Infect) - "Pediatric mucous membrane pemphigoid with ocular involvement is a rare condition of which few reports have been published, resulting in scarce information regarding its clinical course and response to treatment. We report the first case observed in a Hispanic patient, opening with peripheral ulcerative keratitis, and responding successfully to methotrexate."

Journal • Conjunctivitis • Immunology • Inflammation • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics

Predictive Factors for Long-Term De Novo Intraocular Pressure Elevation After Descemet Membrane Endothelial Keratoplasty. (PubMed, Cornea) - "Pseudoexfoliation, prolonged steroid use, and peripheral anterior synechiae were identified as risk factors for IOP elevation after DMEK. In these complex cases, switching to a milder steroid at an earlier stage may be recommended, provided that the balance is maintained to avoid compromising graft survival."

Biomarker • Journal • Glaucoma • Ophthalmology • Transplantation

Effects of Loteprednol Etabonate and Ketorolac Tromethamine on Intraocular Inflammation and Oxidative Stress After Paracentesis-Induced Blood-Aqueous Barrier Breakdown in Cats. (PubMed, Vet Ophthalmol) - "LE and KT effectively reduced PGE2 levels following paracentesis. LE also significantly decreased TP levels, mitigated miosis, and preserved GSH, indicating reduced oxidative stress. Considering that KT also reduced PGE2 levels, further studies are warranted to determine whether KT might effectively reduce protein influx into the anterior chamber at later time points."

Journal • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

Improved Therapy of Ocular Inflammation via Eyedrops Containing Mucoadhesive Drug-Eluting Nanoparticles (ARVO 2025) - "Methods Drug-loaded micelles (PBA-LE-MCs) were synthesized by self-assembly of phenylboronic acid (PBA)-bearing block copolymers with loteprednol etabonate (LE, a corticosteroid) and incorporated into a hyaluronic acid-based matrix to form mucoadhesive eyedrops...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ocular Inflammation • Ophthalmology • IL1B • IL6 • PTPRC

Overcoming barriers in formulating practically insoluble loteprednol etabonate in ophthalmic nanoemulsion. (PubMed, Eur J Pharm Sci) - "LE retention within oil droplets (above 90% of the initial LE content) despite biorelevant dilution simulating tear turnover suggests the potential for direct LE absorption from the NE oil droplets into the lipophilic corneal epithelium. The results obtained encourage the extension of the studies in terms of in vitro permeability and in vivo eye-related bioavailability assessment to prove the potential of the proposed LE formulation."

Journal • Dry Eye Disease • Ophthalmology

Loteprednol etabonate alleviates NLRP3 inflammasome-associated inflammatory diseases in mice by suppressing the transcription of IL-1β. (PubMed, Int J Biol Macromol) - "Furthermore, in mouse models of NLRP3 inflammasome-associated inflammatory diseases, including LPS-induced sepsis and DSS-induced colitis, intraperitoneal injection of LE significantly suppressed inflammatory response and improved mice survival rate. Collectively, these findings identify LE as a novel inhibitor of NLRP3 inflammasome activation, offering a promising therapeutic strategy for the treatment of NLRP3 inflammasome-associated inflammatory diseases."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Septic Shock • IL1B • NLRP3

Preparation of dried nanoemulsion formulation by electrospinning. (PubMed, Eur J Pharm Sci) - "The aim of this study was to investigate electrospinning as a method for the preparation of a solid eye preparation based on nanoemulsion loaded with the anti-inflammatory drug loteprednol etabonate...A rheological study revealed the predominant elastic behavior of the dispersed nanofibers, which indicates the formation of a weak gel after the dispersion of the dried nanoemulsion in tear fluid at the ocular surface. The biocompatibility of the dried nanoemulsions in the form of nanofibers after a single and multiple-dose application was confirmed using the 3D HCE-T model of the stratified epithelium of the human cornea, suggesting that this innovative solid eye preparation could represent a new approach to the treatment of dry eye disease."

Journal • Dry Eye Disease • Ophthalmology

The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain (clinicaltrials.gov) - P=N/A | N=72 | Recruiting | Sponsor: Virginia Polytechnic Institute and State University | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Sep 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Pain • Retinal Disorders

Ophthalmic corticosteroids-related adverse events: the FDA adverse event reporting system (FAERS) database pharmacovigilance study. (PubMed, Front Pharmacol) - "A total of 9,854 ADRs related to ophthalmic corticosteroids were retrieved, with the most frequently reported drugs being Ozurdex (1,784 cases), Lotemax (3,239 cases), and Durezol (2,789 cases)...Additionally, Maxidex has been linked to endocrine disorders, while Ozurdex, Iluvien, and Triesence exhibited significant signals for product issues, likely related to their intraocular injection procedures...These findings highlight the need for careful monitoring and individualized treatment plans to minimize the risk of ADRs in patients receiving corticosteroid therapy. Future studies combining FAERS data with large-scale clinical research are needed to explore these safety concerns further."

Adverse events • Journal • Cataract • Endocrine Disorders • Infectious Disease • Inflammation • Ocular Inflammation • Ophthalmology • Pain • Retinal Disorders • Uveitis

Prolonged Release Niosomes For Ocular Delivery of Loteprednol: Ocular Distribution Assessment on Dry Eye Disease Induced Rabbit Model. (PubMed, AAPS PharmSciTech) - "Loteprednol etabonate (LE) is a topical corticosteroid for the symptomatic management of ocular conditions, encompassing both allergic and infectious etiologies...No irritation or hemorrhagic situation was observed according to the results of HET-CAM study. Thus, novel LE-loaded niosomal formulations could be considered as a promising treatment option for the dry-eye-disease (DED) due to enhanced bioavailability and decreased side effects."

Journal • Preclinical • Dry Eye Disease • Hematological Disorders • Ophthalmology

Exploring the Influence of Drug Substance Solid-State Properties on the In Vitro Drug Release Performance of Dexamethasone Ophthalmic Ointments (ARVO 2024) - "Purpose: This study aims at (i) exploring how variations in polymorphic forms, crystallinity, and particle size distribution of dexamethasone (DEX) affects its in vitro release (IVR) performance from ophthalmic ointments, and (ii) to integrate these findings with research on loteprednol etabonate (LTE) and acyclovir (ACY) ointments, to offer a broader perspective on the effect of drug substance characteristics on IVR... The solid-state characteristics of DEX significantly influence its IVR from ophthalmic ointments, being more influenced by solid-state form, particularly the amorphous state, than by particle size. This phenomenon is also observed in LTE ointments.1 Both DEX and LTE, being moderately lipophilic compounds (logP = 1.8-2.0), demonstrate a strong affinity for the oleaginous base, and are subject to size reduction and normalization through high-shear mixing with petrolatum. Conversely, for the hydrophilic drug ACY (logP = -1.6), particle size is crucial, with..."

Preclinical • Ophthalmology