difluprednate ophthalmic emulsion / Generic mfg. - LARVOL DELTA

4D-150-C004: A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2) (clinicaltrialsregister.eu) - P2/3 | N=298 | Recruiting | Sponsor: 4d Molecular Therapeutics Inc.

New P2/3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Drugs Associated with Pediatric Cataracts: A Real-World Pharmacovigilance Study. (PubMed, Children (Basel)) - "Difluprednate showed the highest pharmacovigilance signal (ROR: 963.67; 95% CI: 316.27-2936.31; n = 4). Notably, CFTR modulators exhibited striking signals: ivacaftor (ROR: 30.75; 95% CI: 18.06-52.37; n = 14), elexacaftor-ivacaftor-tezacaftor (ROR: 15.58; 95% CI: 9.86-24.63; n = 19), and ivacaftor-lumacaftor (ROR: 13.2; 95% CI: 7.9-22.07; n = 15). This study provides a comprehensive large-scale pharmacovigilance profile of drug-induced pediatric cataracts, identifying agents with high-risk pharmacovigilance signals and underscoring the need for proactive ocular monitoring. These findings can inform clinical decision making and prevention strategies and guide future mechanistic research."

Adverse events • Journal • Real-world evidence • Cataract • Cystic Fibrosis • Genetic Disorders • Immunology • Oncology • Ophthalmology • Pediatrics • Pulmonary Disease • Respiratory Diseases • CFTR

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Difluprednate Ophthalmic Emulsion, 0.05% (ExpressPharma) - "Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery and also indicated for the treatment of endogenous anterior uveitis....The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Durezol Ophthalmic Emulsion, 0.05%, of Sandoz."

ANDA • Ocular Inflammation • Ophthalmology • Uveitis

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

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

Optical Coherence Tomography (OCT) Biomarkers for Nonsurgical Management of Postvitrectomy Secondary Macular Holes With Intravitreal Triamcinolone Acetonide (1 mg/0.1 mL): A Case Report of Two Cases. (PubMed, Case Rep Ophthalmol Med) - "There have been reports on the closure of secondary macular holes with the intravitreal injection of triamcinolone acetonide, intravitreal bevacizumab, aflibercept, NSAID, and difluprednate. The identification of OCT biomarkers prior to vitrectomy can help in targeted use of nonsurgical treatment modalities in the management of secondary macular holes with the intravitreal injection of triamcinolone acetonide (1 mg/0.1 mL). Identification of OCT biomarkers can help in the nonsurgical management of secondary macular holes."

Biomarker • Journal • Macular Edema • Mood Disorders • Ophthalmology • Retinal Disorders

Uveitis associated with immunotherapy and its response to monotherapy with difluprednate: A case report. (PubMed, Arch Soc Esp Oftalmol (Engl Ed)) - "Symptoms include decreased visual acuity, pain, redness, and photophobia, which typically resolve with appropriate anti-inflammatory therapy. The aim of this work is to report a case of uveitis in a patient on ipilimumab and nivolumab for the treatment of metastatic melanoma, as well as the response to therapy with difluprednate."

Journal • Monotherapy • Ocular Inflammation • Ophthalmology • Pain • Uveitis

A case report on acute cystoid macular edema days after YAG laser capsulotomy. (PubMed, Int J Surg Case Rep) - "Our experience suggests that colleagues should consider NSAIDS pre- and post- YAG laser capsulotomy to prevent CME. This case highlights the importance of following appropriate management for CME regardless of timeframe of presentation to ensure results."

Journal • Cataract • Macular Edema • Ophthalmology

Genome sequencing of an ESBL-producing E. coli BLRI_001 strain harboring blaTEM-176 and blaEC-15 variants isolated from a live bird market in Dhaka, Bangladesh. (PubMed, Microbiol Resour Announc) - "We report the genome sequence of an ESBL-producing Escherichia coli BLRI_001 strain (O8:H11, ST6018, phylogroup A) isolated from a live bird market in Dhaka, Bangladesh, harboring blaTEM-176, blaEC-15, with 6 replicon plasmids, 13 virulence genes, 11 antibiotic resistance genes, and 2 biocide resistance genes."

Journal

A Retrospective Data Analysis of Patients Treated with Difluprednate and Bromfenac for Cystoid Macular Edema After Uveitis or Cataract Surgery. (PubMed, Clin Ophthalmol) - "The ANOVA test revealed significant differences among treatment groups (F-value: 6.455, P-value: <0.00001), and Tukey's HSD test showed that difluprednate and bromfenac significantly outperformed other medications in treating cystoid macular edema (CME) by reducing resolution times by 5.40 months compared to ketorolac alone (P = 0.0011), 4.76 months compared to ketorolac and prednisolone acetate (P = 0.0001), 5.42 months compared to loteprednol and nepafenac (P < 0.0001), 5.40 months compared to dexamethasone and nepafenac (P < 0.0001), and 4.47 months compared to no treatment (P = 0.0240). Difluprednate and bromfenac also had no cases of CME recurrence. Difluprednate and bromfenac proved to be the most effective treatment regimen for cystoid macular edema (CME), resolving the condition in the shortest amount of time and requiring less frequent dosing."

Journal • Retrospective data • Cataract • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Steroids and Cross-Linking for Ulcer Treatment: The SCUT II Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P3 | "This was a National Institutes of Health (NIH)-funded, sham, placebo-controlled trial randomizing participants to topical moxifloxacin, 0.5%, plus topical placebo plus sham CXL, vs topical moxifloxacin, 0.5%, plus difluprednate, 0.05%, plus sham CXL, vs topical moxifloxacin, 0.5%, plus difluprednate, 0.05%, plus CXL. Results of this randomized clinical trial reveal that adjunctive topical corticosteroids were not superior to placebo, and adjunctive CXL had increased scar size, suggesting that these alternative therapies, on average, may not be superior to topical antibiotics alone for treatment of bacterial keratitis. ClinicalTrials.gov Identifier: NCT04097730."

Clinical • Journal • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Transplantation

Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System. (PubMed, Sci Rep) - "Disproportionality analysis identified 24 drugs significantly associated with cataract risk, with the highest risks linked to glucocorticoids (e.g., fluticasone furoate, triamcinolone), insulin analogs (e.g., insulin glargine, insulin human), and other agents like nitisinone and ranibizumab. Difluprednate showed the strongest association (Bayesian Confidence Propagation Neural Network [BCPNN] = 7.83), followed by prednisolone (BCPNN = 6.84) and erdafitinib (BCPNN = 5.44)...The majority of cases were reported in females (57.9%), with a noticeable annual increase in cases. This study provides a comprehensive pharmacovigilance evaluation, offering insights into high-risk medications, their onset patterns, and demographic trends, contributing to improved clinical decision-making and cataract prevention strategies."

Adverse events • Journal • Cataract • Oncology • Ophthalmology

A Nanomicelles Platform Delivery System for Water-Insoluble Corticosteroid to Treat Anterior Uveitis. (PubMed, AAPS J) - "Further, Dicel improved the anti-inflammatory activity of difluprednate at one and two times a day administration compared to four times a day administration of difluprednate emulsion. The present study highlights the role of topical nanomicelles in delivering difluprednate, which is better than the existing marketed emulsion in the management of ocular inflammation."

Journal • Inflammation • Ocular Inflammation • Ophthalmology • 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: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jul 2025 ➔ Jun 2026

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

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