- |||||||||| Xiidra (lifitegrast) / Bausch Health
Review, Journal: Managing Dry Eye Disease with Novel Medications: Mechanism, Study Validity, Safety, Efficacy, and Practical Application. (Pubmed Central) - Feb 23, 2024
In conclusion, these FDA-approved novel medications exhibit safety and efficacy in managing DED. Further research is needed on long-term outcomes, efficacy, and side-effect comparisons, and combination therapy benefits.
- |||||||||| Durezol (difluprednate ophthalmic emulsion) / Senju, Novartis
Journal: Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates. (Pubmed Central) - Feb 21, 2024
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.
- |||||||||| loteprednol etabonate / Generic mfg.
Journal: Engineering a drug eluting ocular patch for delivery and sustained release of anti-inflammatory therapeutics. (Pubmed Central) - Jan 22, 2024
Herein, we engineered a photocrosslinkable adhesive patch (GelPatch) incorporated with micelles (MCs) loaded with Loteprednol etabonate (LE) for delivery and sustained release of drug...In addition, subcutaneous implantation of the MC loaded GelPatch in rats confirmed its in vivo biocompatibility and stability within 28 days. This non-invasive, adhesive, and biocompatible drug eluting patch can be used as a matrix for the delivery and sustained release of hydrophobic drugs.
- |||||||||| loteprednol etabonate / Generic mfg.
Trial primary completion date: The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain (clinicaltrials.gov) - Jan 22, 2024
P=N/A, N=72, Recruiting,
This non-invasive, adhesive, and biocompatible drug eluting patch can be used as a matrix for the delivery and sustained release of hydrophobic drugs. Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| loteprednol etabonate / Generic mfg.
Journal: Determination of the Toxicity Preferences of Ocular Drug Delivery System by Comparing Two Different Toxicity Bioassays. (Pubmed Central) - Nov 3, 2023
The toxicity of loteprednol etabonate loaded solid lipid nanoparticles, lipid nanostructured carriers, and nanoemulsion were compared...It is noteworthy that the HET-CAM assay offers a more cost-effective and environmentally friendly alternative to the MTT assay, as it does not require cell culture and generates less toxic waste. This information may be useful to consider when selecting between the two assays.
- |||||||||| loteprednol etabonate / Generic mfg.
Enrollment open: The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain (clinicaltrials.gov) - Jun 15, 2023
P=N/A, N=72, Recruiting,
Furthermore, the lack of a significant cytotoxic effect on a sensitive corneal epithelial cell line makes it a candidate for further biological studies. Not yet recruiting --> Recruiting
- |||||||||| loteprednol etabonate / Generic mfg., Durezol (difluprednate ophthalmic emulsion) / Senju, Novartis, prednisolone acetate ophthalmic suspension / Generic mfg.
Preclinical, Journal: Discovery and Preclinical Development of Novel Intraocular Pressure-Lowering Rho Kinase Inhibitor: Corticosteroid Conjugates. (Pubmed Central) - Mar 21, 2023
In addition, anti-inflammatory outcomes were observed with compound 1 (0.1%) relative to Lotemax or vehicle control in an AED mouse model. ROCK'Ster compound 1 is a novel compound suitable for topical ocular dosing that possesses IOP-lowering capability along with similar anti-inflammatory activity compared with marketed steroids.
- |||||||||| loteprednol etabonate / Generic mfg., cyclosporin A microemulsion / Generic mfg.
Review, Journal: Topical corticosteroids for dry eye. (Pubmed Central) - Oct 28, 2022
We included randomized controlled trials (RCTs) in which topical corticosteroids, alone or in combination with tobramycin, were compared with no treatment, artificial tears (AT), vehicles, AT plus tobramycin, or cyclosporine A (CsA)...The effect of topical steroids compared to CsA alone on TBUT (MD 0.37 s, 95% CI -0.13 to 0.87) or tear osmolarity (MD 5.80 mOsm/kg, 95% CI -0.94 to 12.54; loteprednol etabonate alone) is uncertain because the certainty of the evidence is low or very low...The available evidence is also very uncertain regarding the adverse effects of topical corticosteroids on IOP elevation or cataract formation or progression. Future trials should generate high certainty evidence to inform physicians and patients of the optimal treatment strategies with topical corticosteroids in terms of regimen (types, formulations, dosages), duration, and its time-dependent adverse profile.
- |||||||||| loteprednol etabonate / Generic mfg.
Journal: Development of Lipid Nanoparticles for Transdermal Loteprednol Etabonate Delivery. (Pubmed Central) - Jul 23, 2022
They were found to be stable both physically and chemically at room temperature. SLN and NLC formulations of LE can be stated among the systems that can be an alternative to conventional systems with less side-effect in the treatment of inflammatory problems.
- |||||||||| loteprednol etabonate / Generic mfg., cyclosporine ophthalmic emulsion / Generic mfg.
Trial completion, Trial completion date, Trial primary completion date, Monotherapy: Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax (clinicaltrials.gov) - May 11, 2022
P4, N=30, Completed,
The results of this clinical trial demonstrate that LE and FML treatment was effective with no clinically meaningful effect on IOP following a short course of treatment. Recruiting --> Completed | Trial completion date: Oct 2021 --> Feb 2022 | Trial primary completion date: Jun 2021 --> Feb 2022
- |||||||||| Ecclock (sofpironium bromide) / Brickell, Kaken Pharma
Journal: SUPPLEMENT ARTICLE: A Novel Drug Delivery Method: Retrometabolic Drug Design. (Pubmed Central) - Apr 14, 2022
Soft drugs have been approved for use in multiple medical specialties, such as the soft corticosteroid loteprednol etabonate for treatment of inflammatory ophthalmic disorders and soft beta-blocker derivatives for treatment of hypertensive emergencies in cardiology...The soft anticholinergic sofpironium bromide represents the latest expansion of soft drug use in dermatology for the treatment of primary axillary hyperhidrosis (PAH)...J Drugs Dermatol. 2022;21:4(Suppl 2):s5-10.
- |||||||||| Triesence (triamcinolone acetonide injectable suspension) / Novartis
Clinical, Review, Journal: Corticosteroids in ophthalmology: drug delivery innovations, pharmacology, clinical applications, and future perspectives. (Pubmed Central) - Apr 8, 2022
Prednisolone, prednisolone acetate, dexamethasone, triamcinolone acetonide, fluocinolone acetonide, and loteprednol etabonate are amongst the most widely used ophthalmic corticosteroids...Invasive drug administration via intracameral, subconjunctival, and intravitreal injection can enhance ocular bioavailability and minimize dose and dosing frequency of administration, yet may exacerbate ocular side effects of corticosteroids. This review provides a critical appraisal of the ophthalmic uses of corticosteroid, routes of administration, drug delivery fundamentals and novel ocular implantable steroid delivery systems, factors influencing side effects, and future perspectives for ocular corticosteroid therapy.
- |||||||||| loteprednol etabonate / Generic mfg.
Clinical, Journal: The effects of ocular surface disease on optical coherence tomography test results in patients with glaucoma. (Pubmed Central) - Nov 25, 2021
Patients were treated with topical preservative free polyvinyl alcohol + povidone artificial tear drops four times a day for at least 20 days and topical loteprednol etabonate drops four times a day for 1 week...There was a strong positive correlation between pre-treatment signal quality measurements and Schirmer II test values (p < 0.0001). Treatment of OSD in glaucoma patients being treated with long-term anti-glaucoma medications, seem to improve the quality and reliability of OCT test results.
- |||||||||| dexamethasone / Generic mfg., loteprednol etabonate / Generic mfg., cytarabine / Generic mfg.
Clinical, Journal: Cytarabine-Induced Corneal Toxicity: Clinical Features and Relief of Symptoms with Loteprednol Etabonate 0.5% in Two Patients (Pubmed Central) - Nov 21, 2021
Although there is no standardized treatment protocol for cytarabine-induced corneal toxicity, dexamethasone 0.1% and prednisolone phosphate 1.0% were reported to be effective in the resolution of discomfort and symptoms. In the two patients we report herein, loteprednol etabonate 0.5% four times daily was also effective in suppressing the symptoms.
- |||||||||| loteprednol etabonate / Generic mfg.
Clinical, Journal: Effect of steroid eyedrops after trabeculectomy in glaucoma patients: a keratograph analysis. (Pubmed Central) - Aug 15, 2021
The present study not only confirms the high prevalence of clinical findings of ocular surface disease in glaucoma patients but also reveals new objective parameters measured by keratograph analysis. Apart from using loteprednol etabonate ophthalmic suspension 0.5% 1 week before the surgery, our sample presented a worsening of conjunctival hyperemia (bulbar redness by keratograph) and also a shorter noninvasive tear breakup time postoperatively.
- |||||||||| loteprednol etabonate / Generic mfg.
Safety and Efficacy of KPI-121 Ophthalmic Suspension 0.25% for Dry Eye Disease in Three Phase Three Randomized Controlled Trials () - Jul 19, 2021 - Abstract #ASCRSASOA2021ASCRS_ASOA_275;
Significant improvements in CH at Day 15 were demonstrated in all 3 trials, STRIDE 1 (p<0.0001), STRIDE2 (p<0.0001), and STRIDE 3 (p<0.0001).The most frequently reported adverse event in all 3 trials was instillation site pain (4.9% for KPI-121 0.25% and 4.0% for vehicle).The incidence of intraocular pressure increase was comparable to vehicle.ConclusionIn all three Phase 3 trials, KPI-121 0.25% improved both signs and symptoms of DED when dosed QID for 2 weeks. KPI 121 0.25% appeared to be safe and well-tolerated and the incidence of IOP elevation was similar between the KPI-121 0.25% and vehicle arms.
- |||||||||| loteprednol etabonate / Generic mfg.
[VIRTUAL] Characterization and Development of a Novel Loteprednol Etabonate Eluting Adhesive Ocular Patch () - May 13, 2021 - Abstract #ARVO2021ARVO_3660;
The adhesive patch successfully loads a hydrophobic drug and allows for sustained release for up to 10 days. Our NP DDS can address critical factors in ocular injury care by its potential use in ocular injury sealing and drug delivery which can increase drug bioavailability without need for complicated and high frequency drug regimen.
- |||||||||| Veramyst (fluticasone furoate nasal spray) / GSK, Xolair (omalizumab) / Roche, Novartis
Journal: Drugs for allergic rhinitis and allergic conjunctivitis. (Pubmed Central) - Apr 20, 2021
Our NP DDS can address critical factors in ocular injury care by its potential use in ocular injury sealing and drug delivery which can increase drug bioavailability without need for complicated and high frequency drug regimen. No abstract available
- |||||||||| loteprednol etabonate / Generic mfg.
[VIRTUAL] Scleritis (Track 1 - Academy at Home) - Oct 14, 2020 - Abstract #AAOPT2020AAOPT_838;
He was on a long-term maintenance dose of Lotemax once a day in the right eye...Timely treatment is important to prevent secondary complications such as keratitis, uveitis and glaucoma. Careful evaluation of the patient’s presenting signs and symptoms and a targeted case history is critical for appropriate diagnosis and management.
- |||||||||| Lotemax SM (loteprednol etabonate ophthalmic gel 0.38%) / Bausch Health
[VIRTUAL] A Case of Enucleation Following Poorly Controlled Ocular Surface Disease Status Post Dacryoadenectomy (Track 1 - Academy at Home) - Oct 14, 2020 - Abstract #AAOPT2020AAOPT_672;
Amniotic membranes and scleral lenses may also delay the need for enucleation and should have been considered along with prophylactic antivirals given the prior HSK and steroid use.2,3 Conclusion There are a variety of options disposable to treat DED, but the underlying cause should be considered in order to tailor treatment accordingly. This case demonstrates the serious consequences that can arise from poorly controlled OSD due to dacryoadenectomy, and the need for aggressive therapeutic intervention.
- |||||||||| loteprednol etabonate / Generic mfg.
[VIRTUAL] Herpes Zoster Ophthalmicus Progressing to Encephalitis (Track 1 - Academy at Home) - Oct 14, 2020 - Abstract #AAOPT2020AAOPT_137;
While uncommon, herpes zoster encephalitis is a severe presentation requiring urgent attention. Treatment, Management Initial Visit: Patient instructed to begin Valtrex 1g TID PO and to start Lotemax TID OS...While uncommon in patients who are young or immunocompetent, it is imperative to educate patients on the possibility of advanced disease and importance of compliance with oral antivirals. MRI is a more sensitive tool for detection of encephalitis when compared to CT.
- |||||||||| loteprednol etabonate / Generic mfg.
Journal: Innovations in topical ocular corticosteroid therapy for the management of postoperative ocular inflammation and pain. (Pubmed Central) - Sep 25, 2020
This drug has been formulated for topical ophthalmic use after surgery as 0.5% and 1% suspensions, a 0.5% ointment, and a 0.5% gel. Preclinical and clinical data for a new 0.38% LE gel will be reviewed demonstrating that reducing the drug particle size to the nanometer range in diameter provides effective ocular tissue penetration and resolution of pain and inflammation despite a reduced drug concentration (0.38%) and dosing frequency.
- |||||||||| loteprednol etabonate / Generic mfg.
PK/PD data, Journal: Rheological Properties, Dissolution Kinetics, and Ocular Pharmacokinetics of Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38. (Pubmed Central) - Sep 24, 2020
Preclinical and clinical data for a new 0.38% LE gel will be reviewed demonstrating that reducing the drug particle size to the nanometer range in diameter provides effective ocular tissue penetration and resolution of pain and inflammation despite a reduced drug concentration (0.38%) and dosing frequency. LE (submicron) gel 0.38% demonstrated similar rheological properties to micronized LE gel 0.5% but faster dissolution, thus providing similar or higher LE concentrations in the aqueous humor, cornea, and iris-ciliary body after ocular dosing in rabbits despite a lowered concentration of drug in the formulation.
- |||||||||| loteprednol etabonate / Generic mfg., bromfenac ophthalmic solution / Generic mfg.
Journal: Comparison of 2 regimens of loteprednol etabonate and bromfenac for cataract surgery. (Pubmed Central) - Aug 29, 2020
Our data suggest that both groups had similar outcomes with respect to control of ocular inflammation with no differences in adverse outcomes. The compliance questionnaire also suggests a patient preference for the dosing regimen with lower frequency of drop application.
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