difluprednate ophthalmic emulsion / Generic mfg. - LARVOL DELTA

Time Required for Topical Difluprednate to Suppress the Intradermal Histamine-Induced Vascular Reaction in Dogs. (PubMed, Vet Dermatol) - "Difluprednate lotion suppressed the HVR when applied 5, 10 and 30 min before histamine injection, indicating detectable dermal GC activity at the evaluated time points. Information regarding contact times at which topical GC effects can be detected may help clinicians to provide contact-time instructions and improve treatment management."

Journal • Dermatology • Inflammation

Evaluating the Efficacy and Safety of Topical Difluprednate in Patients with Chronic Central Serous Chorioretinopathy. (PubMed, Retina) - "Topical difluprednate produced superior anatomical and functional improvements in SRF resolution, SFCT reduction, and retinal sensitivity within 3-mm when compared with oral eplerenone and observation. Thus, with a manageable safety profile, it may serve as an effective therapeutic option for cCSCR."

Journal • Cardiovascular • Glaucoma • Ophthalmology • Retinal Disorders

Acral lentiginous melanoma metastases to the vitreous masquerading as uveitis: A case report. (PubMed, Am J Ophthalmol Case Rep) - "This is an 86-year-old Caucasian female with Stage III Acral Lentiginous Melanoma of the left heel who was initiated on nivolumab and relatlimab along with intralesional talimogene laherparepvec (TVEC)...She was diagnosed elsewhere with unilateral acute intermediate uveitis, leading to discontinuation of immunotherapy and initiation of topical difluprednate...The patient underwent a therapeutic pars plana vitrectomy, intravitreal melphalan injection, and ocular radiotherapy, with resolution of vitreous metastasis. Several atypical, red flags in this patient may serve as clinical indicators; history of malignancy with locoregional progression, timing of immune CPI therapy to symptom onset, failure to treatment response, and large white, amelanotic vitreous cells arranged in veils. This case emphasizes the importance of maintaining a broad differential diagnosis in patients with atypical, or treatment resistant uveitis, especially in individuals with known underlying..."

Journal • Cutaneous Melanoma • Immunology • Melanoma • Ocular Inflammation • Oncology • Ophthalmology • Solid Tumor • Uveitis

Physicochemical characterisation of difluprednate and 6α9α-difluoroprednisolone: Determination of solubility, pKa and LogP. (PubMed, Steroids) - "The pKa values for DFBA were 1.5 and 7.2 and for DFP, were 5.9 and 10.8. The characterisation of the physicochemical properties of DFBA and DFP can help support efficient formulation development."

Journal

Epidemiological and genotypic analysis of Candida albicans outbreak in a neonatal ward. (PubMed, BMC Infect Dis) - "Among neonates with extremely or very low body weight, central venous catheter-related candidemia was the most frequent, and the contaminated hands of medical staff were likely a medium of transmission or the staff was contaminated with the candida from the neonates. This study highlights the utility of WGS in detecting and understanding hospital outbreaks, helping to trace transmission routes and improve infection control."

Journal • Critical care • Infectious Disease

An Alternative Model of Choroidal Neovascularization in Non-human Primates Results in a Higher Success Rate of CNV Induction and Inhibition of Leakage with Eyela and Lucentis (ASGCT 2026) - "The second animal received weekly systemic corticosteroid therapy and topical difluprednate until IOI alleviated on Day 29. Qualitative analysis of the CNV lesions showed successful induction of leakage in all eyes and rescue with Eylea and Lucentis.Figure 2a and 2b. Distribution of the severity of leakage in PBS, Lucentis, or Eylea administered eyes."

Age-related Macular Degeneration • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ixoberogene soroparvovec (Ixo-vec) intravitreal gene therapy for neovascular age-related macular degeneration (nAMD): Phase 2 LUNA Trial 2-year results (ARVO 2026) - P2, P3 | "Eligible participants were randomized to Ixo-vec 6x1010 vg/eye (6E10) or 2x1011 vg/eye (2E11) and one of four prophylactic regimens: topical difluprednate ± IVT dexamethasone ± oral prednisone. Conclusions Administration of a single IVT injection of Ixo-vec to individuals with nAMD and a high injection burden was well tolerated and resulted in stable BCVA and CST and a marked reduction in injection burden through 2 years. A Phase 3 trial evaluating Ixo-vec in individuals with nAMD is underway (ARTEMIS, NCT06856577)."

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

IVIEW-1201D: A Novel In-situ Gel forming Combination of Povidone-Iodine and Difluprednate for the Treatment of Acute Adenoviral Conjunctivitis (ARVO 2026) - "Phase 3 clinical plan evaluating IVIEW-1201D, PVP-I alone (IVIEW-1201-2G), and vehicle in the treatment of adenoviral conjunctivitis was developed. Conclusions IVIEW-1201D (1.25% PVP-I/0.05% DFBA) demonstrated acceptable ocular tolerability, favorable PK bridging to the reference listed drugs. A differentiated dual-action profile enables the initiation of pivotal trials to simultaneously target the infectious and inflammatory components of acute adenoviral conjunctivitis."

Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Alternaria is an infrequent cause of ocular infection with a wide range of clinical presentations (ARVO 2026) - "She was treated initially with topical natamycin followed by topical voriconazole, which led to eventual recovery to 20/20 vision.Case 2: A patient with rheumatoid arthritis and chronic anterior scleritis with associated uveitis worsened after increasing his difluprednate dose. We describe three cases illustrating differences in onset, severity, and treatment response, ranging from medical therapy with voriconazole to the need for intensive antifungal injections or corneal transplantation. These cases emphasize considering fungal etiologies in atypical or nonresponsive keratitis."

Clinical • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Scleritis • Uveitis

Steroids and Cross-linking for Ulcer Treatment Trial II (SCUT II): Secondary 12 Month Clinical Outcomes of a Randomimzed Controlled Trial (ARVO 2026) - "Eligible participants were randomized 1:1:1 to of of three treatment arms: (1) topical 0.5% moxifloxacin plus topical placebo plus sham CXL, (2) topical 0.5% moxifloxacin plus difluprednate 0.05% plus sham CXL, (3) topical 0.5% moxifloxacin plus difluprednate 0.05% plus CXL...After correcting for baseline infiltrate/scar size, there was no difference in 12 month infiltrate/scar size with adjunctive topical steroid versus placebo (-0.15; CI -0.54 to 0.24; P=0.451) or with adjunctive crosslinking and topical steroid versus adjunctive topical steroid alone (0.47; CI -0.001 to 0.95; P=0.055). Conclusions We were unable to find additional clinical benefit or harm of adjunctive topical steroids for bacterial keratitis in terms of visual acuity or scar size at 12 months."

Clinical • Clinical data • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

IND-Enabling CMC and Nonclinical Toxicology to Support Clinical Development of IVIEW-1701 for the Treatment of Postoperative Ocular Inflammation and Pain (ARVO 2026) - "Conclusions IVIEW-1701, a preservative-free 0.03% difluprednate nanomicelle gel-forming solution, demonstrates differentiated ocular and systemic findings relative to the marketed 0.05% product and represents a novel approach for postoperative inflammation and pain management. The clinical safety and efficacy of IVIEW-1701 will be evaluated in a Phase 3 registration program."

Clinical • Ocular Inflammation • Ophthalmology

Real-World Outcomes with Intravitreal Syfovre and Izervay in High-Volume Private Retina Clinic: A Two-Year Study (ARVO 2026) - "One eye developed retinal vasculitis confirmed by angiography and was treated with prednisone, difluprednate, and pressure-lowering drops; at month 2, logMAR BCVA plateaued at 1.3 from 0.47. One eye underwent RD repair following IVS and IV faricimab...Conclusions Our data reflects preliminary outcomes of IVS/IVI in routine clinical practice. Final analysis is pending."

Clinical • Real-world • Real-world evidence • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology

Spread of carbapenemase-producing Serratia spp. in France from 2016 to 2024: a comparative genomic study. (PubMed, Emerg Microbes Infect) - "MLST identified 67 sequence types (ST) with 42% of the isolates belonging to four high-risk clones: ST-601, ST-298, ST-477, ST-600 and ST-474. β-lactams susceptibility was low, but aztreonam-avibactam remained highly active (98%)...The absence of S. marcescens, the genus leader, highlighted the need of updating MALDI-TOF database. This study highlights Serratia as an underestimated reservoir of multidrug resistance."

Journal • Infectious Disease

Zebrafish Functional Screening of FDA-Approved Drugs for Autosomal Dominant Retinitis Pigmentosa Caused by RHODOPSIN Q344X Mutation. (PubMed, bioRxiv) - "To address this challenge, we screened an FDA-approved compound library using a zebrafish adRP model expressing a human RHODOPSIN transgene with the Q344X mutation...Four compounds significantly improved VMR in Q344X zebrafish: amitriptyline, difluprednate, maprotiline, and prednisolone. Further characterization revealed that these hits act through distinct mechanisms, including reducing rod death, promoting rod neogenesis, and enhancing the function of extraocular photoreceptors. Together, these findings demonstrate the potential to repurpose these drugs for adRP caused by the RHO Q344X mutation, providing preclinical candidates and revealing potential targets for future drug development."

FDA event • Journal • Genetic Disorders • Inherited Retinal Dystrophy • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinitis Pigmentosa

Treatment of Central Serous Chorioretinopathy With Topical Difluprednate: A Literature Review. (PubMed, Cureus) - "The short- and long-term effects of difluprednate for CSR treatment are not well-established. Future clinical trials can provide further insights into the rationale of difluprednate therapy for CSR treatment, especially because its use is contraindicated by existing evidence."

Journal • Review • Inflammation • Ophthalmology • Pain • Retinal Disorders

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