Durezol (difluprednate ophthalmic emulsion) / Senju, Novartis - LARVOL DELTA

Difluprednate achieves a similar clinical outcome after trabeculectomy compared to prednisolone acetate at a significantly lower drop frequency. (PubMed, Ther Adv Ophthalmol) - "However, fewer drops per day were necessary in the difluprednate group. Both groups showed no difference in the amount by which IOP and AGM were reduced."

Clinical data • Journal • Cataract • Fibrosis • Glaucoma • Immunology • Inflammation • Ophthalmology

Ixoberogene Soroparvovec (Ixo-vec) Intravitreal Gene Therapy for Neovascular Age-Related Macular Degeneration: Phase 2 LUNA 52-Week Data (ARVO 2025) - P2 | "Methods Participants were randomized across two Ixo-vec doses, 6x1010 and 2x1011 vg/eye (6E10 and 2E11) across multiple corticosteroid prophylactic regimens including topical difluprednate ± IVT dexamethasone ± oral prednisone (NCT05536973). 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."

Gene therapy • P2 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Syfovre and Izervay Clinical Outcomes (ARVO 2025) - "One eye developed RV confirmed by angiography and was treated with prednisone, difluprednate, and pressure-lowering drops; at month 2, logMAR VA plateaued at 1.3 from 0.47. One eye underwent RD repair following IVS and IV faricimab...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."

Clinical • Clinical data • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

Difluprednate and Loratadine in the Treatment of Pachychoroid Disease Spectrum (ARVO 2025) - "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."

Macular Edema • Ophthalmology

Evaluating critical quality attributes and Novel drug release testing of difluprednate Nanoemulsions. (PubMed, Int J Pharm) - "In contrast, microdialysis served as a biorelevant method that can be used to test the drug release as early as 2 min with reproducibility and discriminatory ability. It is likely that the above biowaiver approach using a series of product characterization tests and microdialysis as a bio-relevant IVRT method support the industry in generic product development and in establishing in vitro bioequivalence of complex ophthalmic products."

Journal • Ophthalmology

Difluprednate for the Treatment of Postoperative Hypotony Following Complicated Retinal Detachment Surgery. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "Topical difluprednate therapy for hypotony following successful complex RD repair resulted in a statistically significant increase in IOP. [Ophthalmic Surg Lasers Imaging Retina 2025;56:XX-XX.]."

Journal • Ophthalmology • Retinal Disorders

SCUT II: Steroids and Cross-linking for Ulcer Treatment (clinicaltrials.gov) - P3 | N=280 | Completed | Sponsor: Thomas M. Lietman | Active, not recruiting ➔ Completed | Trial primary completion date: Aug 2024 ➔ May 2024

Trial completion • Trial primary completion date • Keratitis • Ocular Inflammation • Ophthalmology

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

Review on the Use of Difluprednate in Inflammatory Eye Disorders: The Topical Steroid That Goes the Distance. (PubMed, Ocul Immunol Inflamm) - "High incidence of cataract formation and progression was also documented in children, thus necessitating vigilant follow-up of children on chronic treatment. This review aims to give a comprehensive and up-to-date overview of difluprednate's pharmacological properties, clinical applications, safety profiles, and alternative delivery methods."

Journal • Review • Cataract • Dermatology • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Pain • Pediatrics • Scleritis • Uveitis

REAGIR II: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II (clinicaltrials.gov) - P3 | N=60 | Recruiting | Sponsor: University of California, San Francisco | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Infectious Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Corticosteroids for the Management of Uveitic Macular Edema: A Comprehensive Review. (PubMed, Ocul Immunol Inflamm) - "The efficacy of different corticosteroid formulations, such as difluprednate, triamcinolone acetonide, dexamethasone implant, and fluocinolone acetonide implant, is evaluated through clinical trials and retrospective studies. Additionally, the role of corticosteroid-sparing treatments, including antimetabolites like methotrexate and mycophenolate mofetil, is explored. Emerging techniques, such as suprachoroidal space triamcinolone acetonide administration, offer promising alternatives for managing UME. Through a thorough examination of current evidence, this review provides valuable insights into optimizing the management of UME and improving visual outcomes in patients with uveitis."

Journal • Review • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Steroids and Cross-Linking for Ulcer Treatment Trial II: Baseline Characteristics. (PubMed, Cornea) - "While corneal ulceration is an important cause of disability in technologically advanced countries, it occurs more frequently in low and middle-income countries, and the implications on these populations should be considered. These baseline factors can be evaluated to address such health care disparities."

Clinical • Journal • Cataract • Glaucoma • Infectious Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Simultaneous determination of 61 hormones in water by solid phase extraction-ultra performance liquid chromatography-tandem mass spectrometry (PubMed, Se Pu) - "In this study, we established a rapid and high-throughput continuous online method based on solid phase extraction (SPE) coupled with ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for the simultaneous determination of 61 hormone components, including 48 glucocorticoids, 1 mineralocorticoid, 4 androgens, and 8 progesterones, in water...Using this method, we successfully detected 10 hormone components (cortisone, fluticasone propionate, ciclesonide, betamethasone dipropionate, clobetasone butyrate, diflucortolone valerate, halobetasol propionate, isoflupredone, difluprednate, and hydroxyprogesterone caproate) in various surface water and groundwater samples collected from the Taihu Basin region...Thus, it exhibits promising potential for tracing targeted hormone residues in water and will be of great value in monitoring and ensuring water safety. Finally, a regional analysis was conducted on the hormone levels in water, and suggestions were..."

Journal

Understanding the link between sample recovery and particle size distributions for characterizing complex drug products using asymmetrical flow field-flow fractionation (ACS-Fall 2024) - "The first examines the impact of excipients on absolute sample recovery of two model drug products: difluprednate ophthalmic emulsion and doxorubicin hydrochloride liposomal injection...Although overt compositional differences significantly outweigh differences in recovery due to size variations, multimodal systems still exhibit some recovery-based variation in PSD. As AF4 is used more frequently, considering the impacts of recovery on particle size distributions may be critical in characterizing samples of mixed analyte composition."

Ophthalmology

REAGIR II: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II (clinicaltrials.gov) - P3 | N=60 | Recruiting | Sponsor: University of California, San Francisco | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Intact NMR Approach Quickly Reveals Synchronized Microstructural Changes in Oil-in-Water Nanoemulsion Formulations. (PubMed, AAPS J) - "Here we demonstrated the analytical methods of intact 19F Nuclear Magnetic Resonance (NMR) and 1H diffusion ordered spectroscopy (DOSY) NMR for their specificity in measuring DPD and OGS, respectively, on three NE formulations containing the active ingredient difluprednate (DFPN) at the same concentration...Collectively, the study illustrated the specificity and essential role of intact NMR methods in measuring the critical microstructure attributes of soft-core NE systems quickly, accurately, and non-invasively. Therefore, the selected NMR approach can be a unique diagnostic tool of molecular microstructure or Q3 property in o/w NE formulation development, and quality assurance after manufacture process or excipient component changes."

Journal

Greenness and whiteness assessment of a sustainable voltammetric method for difluprednate estimation in the presence of its alkaline degradation product. (PubMed, Sci Rep) - "The greenness of the studied approach was evaluated using the Green Analytical Procedure Index and the Analytical Greenness metric. Additionally, the whiteness features of the proposed approach were examined with the recently released red, green, and blue 12 model, and the recommended strategy performed better than the reported approaches in greenness and whiteness."

Journal

Management of Acute Non-Infectious Anterior Uveitis in Adults - Practice Patterns Among Uveitis Specialists in North America. (PubMed, Ocul Immunol Inflamm) - "If there is a lack of treatment response within 2-3 weeks with the initial topical treatment, 42 respondents (41.2%) chose to switch to difluprednate eye drops and 29 (28.4%) recommended switching to oral prednisone. Reported initial medication dosing and follow-up care approaches are highly variable, which suggests heterogeneity in practice patterns. Further research on the optimal initial dosing is needed."

Journal • Ocular Inflammation • Ophthalmology • Uveitis

Safety and efficacy of resident-performed SION goniotomy at the time of cataract surgery (ARVO 2024) - "IOP spikes were possibly related to use of durezol instead of prednisone... Resident-performed SION goniotomy had a safety and short-term efficacy profile similar to what is reported in the resident-performed and attending-performed KDB goniotomy literature. SION goniotomy can be safely and effectively performed by PGY-3 and PGY-4 residents. Training residents in minimally invasive glaucoma surgery should be encouraged."

Clinical • Surgery • Cataract • Diabetic Retinopathy • Glaucoma • Macular Edema • Ophthalmology • Retinal Disorders

Biocompatible nanomicelles to improve the therapeutic outcome of water insoluble drugs to treat anterior segment diseases. (ARVO 2024) - " Nanomicelles loaded with various water-insoluble ophthalmic drugs (Difluprednate loaded nanomicelles, Dicel; Latanoprost loaded nanomicelles, Latcel; and Resveratrol loaded nanomicelles, Recel) were prepared using the thin film hydration method. Nanomicelles were established as a platform delivery technology to improve the solubility and permeability of water-insoluble drugs for ocular application. Additionally, the developed nanomicelles have shown the potential to deliver water insoluble drugs to various therapeutic target site in the anterior segment of the eye. The pre-clinical studies proved that nanomicelles could improve the therapeutic outcome, making it a promising drug delivery platform."

Ophthalmology

Development of Crystalline Corneal Opacities (Steroid Keratopathy) in Dogs After Treatment With Ophthalmic Corticosteroids. (PubMed, Cornea) - "This case series documents the onset of steroid keratopathy in Beagles and Beagle-derived dogs after treatment with ophthalmic corticosteroids. Clinical resolution of steroid keratopathy lesions may be possible after discontinuation of ophthalmic corticosteroids."

Journal • Ophthalmology

Anti-inflammatory medication use after cataract surgery: online survey of practice patterns. (PubMed, J Cataract Refract Surg) - "Most surgeons prescribed topical AIM after routine cataract surgery. Many surgeons injected intraocular or periocular AIM while prescribing topical AIM. The diversity of practice patterns may reflect the lack of clear evidence-based guidelines."

Journal • Surgery • Cataract • Ophthalmology

REAGIR II: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II (clinicaltrials.gov) - P3 | N=60 | Not yet recruiting | Sponsor: University of California, San Francisco

New P3 trial • Infectious Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates. (PubMed, AAPS J) - "The selectivity of difluprednate in HLM is much weaker than that in the recombinant enzymes due to hydrolysis of the acetate group in HLM. Based on the selectivity data, loteprednol etabonate can be utilized as an orthogonal approach, when experimental fraction metabolized of CYP3A5 is greater than 0.5, to understand CYP3A5 contribution to drug metabolism and its clinical significance. Future endeavors to identify even more selective CYP3A5 inhibitors are warranted to enable accurate determination of CYP3A5 contribution to metabolism versus CYP3A4."

Journal • CYP3A5

Postoperative Management of Kahook Dual Blade Goniotomy with Phacoemulsification Cataract Extraction. (PubMed, J Curr Glaucoma Pract) - "Almost 12-month follow-up data were assessed for two common postop regimens-treatment with (1) topical prednisolone acetate 1% with pilocarpine 1% (pred-pilo) or (2) difluprednate 0.05% postoperatively. Postoperative Management of Kahook Dual Blade Goniotomy with Phacoemulsification Cataract Extraction. J Curr Glaucoma Pract 2023;17(4):169-174."

Journal • Cataract • Glaucoma • Ophthalmology