Lotemax SM (loteprednol etabonate ophthalmic gel 0.38%) / Bausch Health - LARVOL DELTA

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Illinois College of Optometry | N=18 ➔ 36

Enrollment change • Allergy • Conjunctivitis • Dry Eye Disease • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Retrospective Assessment of the Routine Use of Loteprednol Etabonate Gel 0.38% Following LASIK and PRK Surgery (ASCRS-ASOA 2023) - "Purpose To assess real world experience using loteprednol etabonate ophthalmic gel, 0.38% (LSM) for postoperative pain and inflammation following laser-assisted in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) surgery.MethodsThis was a retrospective chart review conducted at 4 sites in the United States.Cases from patients aged 18 years and above were eligible for inclusion.Data were collected from routine LASIK (N=240 eyes) or PRK (N=80 eyes) surgery cases (165 patients) in which LSM was used postoperatively as the clinician’s routine standard of care and in which patients had a minimum of one (LASIK) or two (PRK) months follow-up.Data evaluated included refractive characteristics, intraocular pressure (IOP) measurements, LSM dosing regimen, adverse events (AEs) and early discontinuations.The primary outcomes of interest included IOP changes, other AEs, and reasons for any early treatment discontinuation.ResultsCommon LSM dosing regimens were TID..."

Retrospective data • Surgery • Inflammation • Ophthalmology • Pain

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Illinois College of Optometry | Unknown status ➔ Completed | Trial completion date: Jul 2021 ➔ Dec 2021 | Trial primary completion date: Jul 2021 ➔ Dec 2021

Trial completion • Trial completion date • Trial primary completion date • Allergy • Conjunctivitis • Dry Eye Disease • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus (clinicaltrials.gov) - P1; N=20; Enrolling by invitation; Sponsor: Illinois College of Optometry; Not yet recruiting ➔ Enrolling by invitation; Trial completion date: Apr 2021 ➔ Jul 2021; Trial primary completion date: Apr 2021 ➔ Jul 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Allergy • Conjunctivitis • Dry Eye Disease • Immunology • Ocular Inflammation • Ophthalmology

Loteprednol vs. Prednisolone and Fluorometholone (clinicaltrials.gov) - P4; N=131; Completed; Sponsor: University of Utah; N=214 ➔ 131

Clinical • Enrollment change

[VIRTUAL] A Case of Enucleation Following Poorly Controlled Ocular Surface Disease Status Post Dacryoadenectomy (AAOPT 2020) - "Management: lid wipes, Lotemax gel QD, Ocunox QHS, AS QID, Hylo QID, and hot compresses BID. 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."

Clinical • Cataract • Dry Eye Disease • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

LOTEMAX SM (loteprednol etabonate ophthalmic gel), 0.38% and VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% from Bausch + Lomb (Review of Optometry) - "This program is sponsored by Bausch + Lomb.This program is intended for practicing, US-based physicians who have an NPI number/state medical license. No CME/CE will be provided for this program. Only physicians and health care professionals involved in providing patient care or product recommendations may attend this educational program. Attendance by guests or spouses is not permitted."

Live event

Rheological Properties, Dissolution Kinetics, and Ocular Pharmacokinetics of Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38. (PubMed, J Ocul Pharmacol Ther) - "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."

Journal • PK/PD data • Ophthalmology

Combined MIGS & Cataract Surgery Case Study with Dr. Paul Singh (Ophthalmology Times) - "Dr. Paul Singh manages postoperative inflammation and pain with LOTEMAX SM following combined MIGS & Cataract surgery."

Video

Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%: A Review in Post-Operative Inflammation and Pain Following Ocular Surgery. (PubMed, Clin Drug Investig) - "Loteprednol etabonate ophthalmic gel 0.38% (Lotemax SM; hereafter referred to as loteprednol etabonate gel 0.38%) is a topical ophthalmic corticosteroid approved in the USA for the treatment of post-operative inflammation and pain following ocular surgery. Treatment with loteprednol etabonate gel 0.38% had no meaningful impact on intraocular pressure (IOP) or visual acuity. Thus, loteprednol etabonate gel 0.38% extends the treatment options available in resolving post-operative inflammation and pain in patients who have undergone ocular surgery."

Journal • Review • Cataract • Immunology • Ocular Inflammation • Ophthalmology • Pain

Innovations in Inflammation and IOP Control - "Join your peers for a webinar presentation on LOTEMAX SM (loteprednol etabonate ophthalmic gel), 0.38% and VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% from Bausch + Lomb."

Live event

Simplified Regimens, Extended Delivery Options Among Recent Advances in Steroid Delivery for Cataract Surgery (Ocular Science Press Release) - "I still recall the drop packs my attendings used to give our cataract surgical patients when I started residency. Every patient left with a postoperative pack containing an eye shield, sunglasses, an antibiotic drop, a steroid drop, and an NSAID drop....Difluprednate ophthalmic emulsion 0.05% (Durezol, Alcon) was the first steroid that allowed us to reduce dosing....One option is prednisolone phosphate 1%/gatifloxacin 0.5%/bromfenac 0.075% (Omni, OSRX Pharmaceuticals), prescribed t.i.d. for 1 month."

Online posting

Safety and Efficacy of an Intracanalicular Dexamethasone Insert Compared to Topical Loteprednol Etabonate Ophthalmic Gel 0.38% in Patients With Keratoconus Wearing Rigid Gas Permeable Contact Lenses Who Have Been Diagnosed With Allergic Conjunctivitis (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Illinois College of Optometry

Clinical • New P1 trial • Allergy • Conjunctivitis • Dry Eye Disease • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Loteprednol etabonate gel 0.5% vs prednisolone acetate suspension 1% for the treatment of inflammation after cataract surgery in children. (PubMed, J Cataract Refract Surg) - "LE gel 0.5% was safe and effective in treating pediatric post-cataract surgical inflammation, with similar outcomes as PA 1%."

Clinical • Journal • Cataract • Immunology • Ophthalmology • Pediatrics

Advances in drug delivery: Less is more (Healio) - "We have gone from the days of finally having a topical NSAID eye drop to now having it as a once-daily brominated formulation with greater potency (Prolensa, Bausch + Lomb; BromSite, Sun Pharmaceuticals), from the days of finally having an ester topical steroid (Lotemax suspension, Bausch + Lomb) to now having submicron- and nano-formulations of the same with greater aqueous penetration (Lotemax SM, Bausch + Lomb; Inveltys, Kala), from the days of hourly topical steroid prednisolone dosing to now having emulsion formulations (Durezol, Novartis) with greater potency and lower dosing."

Online posting

2019 Year in review: Fight blindness (Healio) - "No. 9. Lotemax SM (loteprednol etabonate ophthalmic gel 0.38%, Bausch + Lomb) was FDA approved for pain and inflammation following ocular surgery, with its submicron particle size delivery system dissolving faster in tears and getting into the aqueous at twice the concentration as its predecessor, Lotemax Gel 0.5%. I like to say the SM stands for 'small but mighty'....No. 1. Fight Blindness, the DJMJ event at The Warfield Theater in San Francisco during the American Academy of Ophthalmology meeting, was a great success, hosted by CEDARS/ASPENS to raise money for the Foundation Fighting Blindness, led by chief operating officer Jason Menzo."