Lotemax

(Loteprednol Etabonate)

ApprovedSmall molecule

Loteprednol etabonate is a steroid eye drop used to reduce inflammation and discomfort in the eyes caused by conditions like allergies, infections, or after eye surgery.[2] Lotemax is currently approved and in use across 10 indications[4].[1]

Lotemax is one of 120 small molecule programs targeting Allergic Conjunctivitis. It is currently in Approved.

Indications

Total Trials

Active Trials

119

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Allergic ConjunctivitisApproved

Keratoconjunctivitis SiccaApproved

Age-Related Macular DegenerationActive, not recruiting

Eye InflammationUnknown

Dry Eye SyndromeUnknown

Anterior UveitisUnknown

KeratoconjunctivitisApproved

ConjunctivitisActive, not recruiting

TreatmentUnknown status

Allergic ConjunctivitisApproved

Approved

Keratoconjunctivitis SiccaApproved

Approved

Active, not recruiting

Eye InflammationPreclinical

Unknown

Dry Eye SyndromePreclinical

Unknown

Anterior UveitisPreclinical

Unknown

KeratoconjunctivitisApproved

Approved

ConjunctivitisApproved

Active, not recruiting

TreatmentPreclinical

Unknown status

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Lotemax

PPharmos

Approved

1 2

Biltricide

Bayer

Preclinical

4 3

Dexilant

Takeda

Preclinical

2 4

Minipress

Pfizer

Preclinical

1 5

Niclocide

Bayer

Preclinical

1 6

Alfenta

Jazz Pharmaceuticals

Preclinical

1 7

Valium

Akero Therapeutics

Preclinical

2 8

Intuniv

PPromius Pharma, LLC

Preclinical

1 9

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 10

Norpramin

VValidus Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Cataract7 trials

Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01475643·107 enrolled

Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01996839·514 enrolled

Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT02208297·326 enrolled

Show 4 more trials

Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01010633·406 enrolled

Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01060072·407 enrolled

Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00699153·400 enrolled

LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT02786901·600 enrolled

Systemic2 trials

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

Completed·BBausch Health Americas, Inc.·Phase 1·NCT03063489·15 enrolled

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations

Completed·BBausch & Lomb Incorporated·Phase 1·NCT03098953·15 enrolled

Dexamethasone2 trials

Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax

Completed·TThomas Chester, OD·Phase 4·NCT04555694·30 enrolled

Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing

Completed·KKhon Kaen University·Phase 4·NCT01724892·32 enrolled

Safety and Efficacy2 trials

Pediatric Zylet Safety and Efficacy Study

Completed·BBausch & Lomb Incorporated·Phase 4·NCT00420628·108 enrolled

A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%

Completed·BBausch & Lomb Incorporated·Phase 4·NCT01437982·140 enrolled

Keratoconjunctivitis2 trials

Zylet vs TobraDex in Blepharokeratoconjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 4·NCT00447577·276 enrolled

Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01028027·357 enrolled

8 more indications

Allergic Conjunctivitis1 trial

Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis

Completed·SSouthern California College of Optometry at Marshall B. Ketchum University·Phase 4·NCT01443442·23 enrolled

Conjunctivitis1 trial

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 4·NCT00705159·137 enrolled

Randomized1 trial

A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®

Withdrawn·—·Phase 4·NCT02028312

MPA1 trial

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

Completed·BBausch & Lomb Incorporated·Phase 2·NCT01107405·101 enrolled

Efficacy1 trial

Efficacy of Loteprednol Ointment Following Eyelid Surgery

Withdrawn·UUniversity of California, San Diego·N/A·NCT01749241

Treatment1 trial

Topical Steroid Treatment For Dry Eye

Unknown status·MMeir Medical Center·N/A·NCT02218827·30 enrolled

Pain1 trial

The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Completed·VVirginia Polytechnic Institute and State University·N/A·NCT05542381·64 enrolled

Steroid1 trial

Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

Completed·CCornea Research Foundation of America·Phase 4·NCT01853696·167 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 9, 1998

ALREX

NDA NDA020803

Mar 9, 1998

LOTEMAX

NDA NDA020583

Mar 9, 1998

LOTEMAX

NDA NDA020841

Apr 15, 2011

LOTEMAX

NDA NDA200738

Sep 28, 2012

LOTEMAX

NDA NDA202872

Aug 22, 2018

INVELTYS

NDA NDA210565

Feb 22, 2019

LOTEMAX SM

NDA NDA208219

Oct 26, 2020

EYSUVIS

NDA NDA210933

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Loteprednol Etabonate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lotemax drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Loteprednol Etabonate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Loteprednol Etabonate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210933). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pharmos company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glucocorticoid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPharmos

Lotemax

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Cataract7 trials

Systemic2 trials

Dexamethasone2 trials

Safety and Efficacy2 trials

Keratoconjunctivitis2 trials

Allergic Conjunctivitis1 trial

Conjunctivitis1 trial

Randomized1 trial

MPA1 trial

Efficacy1 trial

Treatment1 trial

Pain1 trial

Steroid1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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