Drugs / Loteprednol Etabonate
Loteprednol Etabonate
also known as
KPI-121 · lotemax · Lotemax Gel · FML · KPI-121 0.25% Ophthalmic Suspension · Lot · Lotemax (loteprednol etabonate) 0.5%
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOTEMAX | — | 2018-07-20 | fda.gov ↗ |
| Approved | US (FDA) | LOTEMAX | — | 1998-03-09 | fda.gov ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05353101 | Jul 2020 → Jun 2021 | vernal keratoconjunctivitis | Second Affiliated Hospital of Nanchang University | Completed | No outcome recorded |
| Phase 1 | NCT03531697 | Apr 2018 → Sep 2019 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT03098953 | Apr → May 2017 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT03063489 | Feb → May 2015 | asthenopia | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01736527 | Jan 2013 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT01817582 | May 2013 → Jan 2014 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | Missed primary |
| Phase 2 | NCT00560638 | Nov 2005 → Feb 2006 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 311 trials · 4 met primary | ||||||
| Phase 3 | NCT03596723 | Jul → Sep 2018 | — | Kala Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02786901 | Jun 2016 → Jun 2017 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT02208297 | Sep 2014 → Mar 2015 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01996839 | Dec 2013 → May 2014 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01475643 | Jun 2013 → Jun 2017 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01435460 | Aug 2010 → Apr 2011 | conjunctivitis | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase 3 | NCT01060072 | Feb → Sep 2010 | — | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase 3 | NCT01010633 | Nov 2009 → Jun 2010 | — | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase 3 | NCT01028027 | Oct 2009 → Feb 2010 | blepharitis, conjunctivitis, keratitis | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase 3 | NCT00699153 | Jun 2008 → May 2009 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00645671 | Mar 2008 → Mar 2009 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 49 trials · 3 met primary | ||||||
| Phase 4 | NCT07496060 | Aug 2025 → Jan 2026 | anterior uveitis | Fayoum University | Completed | No outcome recorded |
| Phase 4 | NCT05136443 | Nov 2021 → Sep 2023 | corneal edema, corneal endothelial dystrophy | Price Vision Group | Completed | No outcome recorded |
| Phase 4 | NCT04075227 | Oct 2015 → Mar 2019 | conjunctival pterygium, steroid-induced glaucoma | Wannisa Suphachearabhan | Completed | No outcome recorded |
| Phase 4 | NCT01437982 | Aug 2010 → Oct 2015 | giant papillary conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT00447577 | Jan → Jun 2007 | keratoconjunctivitis | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase 4 | NCT00420628 | Nov 2006 → Jan 2009 | chalazion | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT00407043 | Nov 2006 → Sep 2007 | dry eye syndrome | Ophthalmic Consultants of Long Island | Completed | Met primary |
| Phase 4 | NCT00366691 | Feb 2006 → Sep 2007 | cataract | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 4 | NCT00532961 | Feb → Apr 2005 | — | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase not applicable6 trials | ||||||
| — | NCT05542381 | Dec 2022 → May 2024 | age-related macular degeneration | Virginia Polytechnic Institute and State University | Completed | No outcome recorded |
| — | NCT02218827 | Sep 2014 → Sep 2015 | dry eye syndrome | Meir Medical Center | Unknown | No outcome recorded |
| — | NCT02322528 | Apr 2014 → Aug 2015 | Sjogren syndrome | University of Rochester | Completed | No outcome recorded |
| — | NCT01749241 | Sep 2012 → May 2015 | — | University of California, San Diego | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01692652 | Aug 2012 → Mar 2013 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT01695668 | Aug 2011 → Sep 2013 | dry eye syndrome | University of Michigan | Completed | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 0 | NCT04418999 Comparator | Sep 2020 → Dec 2021 | dry eye syndrome, eye allergy, keratoconus | Illinois College of Optometry | Completed | No outcome recorded |
| Phase 2 | NCT02218489 Comparator | Jul 2014 → Dec 2015 | blepharitis | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02188160 Comparator | Jun 2014 → Jan 2015 | dry eye syndrome | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01107405 Comparator | Apr → May 2010 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT05322148 Comparator | Jun → Nov 2022 | dry eye syndrome | Research Insight LLC | Completed | No outcome recorded |
| Phase 3 | NCT03616899 Comparator | Jul 2018 → Feb 2020 | dry eye syndrome | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02819284 Comparator | Jun 2016 → Sep 2017 | dry eye syndrome | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02813265 Comparator | Jun 2016 → Oct 2017 | dry eye syndrome | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02793817 Comparator | Jun 2016 → Mar 2017 | — | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02163824 Comparator | May → Dec 2014 | — | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT07090044 Comparator | Aug 2021 → Dec 2022 | choroidal neovascularization, diabetic retinopathy, macular retinal edema, retinal vein occlusion | Retina Research Institute, LLC | Completed | No outcome recorded |
| Phase 4 | NCT07588074 Comparator | May → Jun 2021 | dry eye syndrome | Harrow Inc | Completed | No outcome recorded |
| Phase 4 | NCT04708821 Comparator | Apr → Sep 2021 | conjunctivitis | Clinical Research Center of Florida | Completed | No outcome recorded |
| Phase 4 | NCT04555694 Comparator | Oct 2020 → Feb 2022 | dry eye syndrome | Thomas Chester, OD | Completed | No outcome recorded |
| Phase 4 | NCT03123614 Comparator | Sep 2014 → Jul 2018 | corneal disorder, ocular hypertension | University of Utah | Completed | No outcome recorded |
| Phase 4 | NCT02120079 Comparator | Feb 2014 → Apr 2017 | dry eye syndrome | Tufts Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02028312 Comparator | Jan 2014 → Feb 2016 | dry eye syndrome | Edward Holland, MD | Withdrawn | No outcome recorded |
| Phase 4 | NCT01853696 Comparator | Mar 2013 → Jan 2015 | Fuchs' endothelial dystrophy, corneal edema | Cornea Research Foundation of America | Completed | No outcome recorded |
| Phase 4 | NCT01724892 Comparator | Nov 2012 → Sep 2013 | corneal disorder | Khon Kaen University | Completed | No outcome recorded |
| Phase 4 | NCT01443442 Comparator | Oct 2011 → Sep 2012 | conjunctivitis | Southern California College of Optometry at Marshall B. Ketchum University | Completed | No outcome recorded |
| Phase 4 | NCT00705159 Comparator | Jun 2008 → Mar 2010 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT00689078 Comparator | May → Jun 2008 | conjunctivitis | ORA, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00781300 Comparator | Mar → Nov 2006 | ocular hypertension, open-angle glaucoma | Federal University of São Paulo | Completed | No outcome recorded |
| — | NCT02245516 Comparator | Jul → Dec 2014 | diabetic macular edema, retinal vein occlusion | Kala Pharmaceuticals, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-07-01 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel lupin.com ↗
Mumbai, Naples, July 1, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%. |
| 2025-01-09 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel lupin.com ↗ |
| 2024-04-25 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Suspension, 0.5% lupin.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-16 | Lupin Limited | Lupin Launches Loteprednol Etabonate Ophthalmic Suspension, 0.5% in the United States lupin.com ↗ |
| 2025-07-01 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel lupin.com ↗ |
| 2025-01-09 | Lupin Limited | Lupin Receives Tentative Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel lupin.com ↗ |
| 2024-04-25 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Suspension, 0.5% lupin.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | loteprednol etabonate | “The purpose of this study is to compare the effectiveness of the NSAID ketorolac tromethamine ophthalmic solution 0.4% with the steroid loteprednol etabonate ophthalmic...” NCT00366691 ↗45“Topical loteprednol etabonate 0.5% (Lotemax, Bausch and Lomb) has been shown to be safe and efficacious in treatment of inflammatory ocular disorders, but has not been...” NCT01695668 ↗ “Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and...” NCT02120079 ↗ “The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with...” PMID 25083776 ↗ Sep 2014 “To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.” NCT01736527 ↗ “A Randomized, Single-blind, Cross-over Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery” NCT03531697 ↗ “Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.” NCT01028027 ↗ |
| Known as | FML | “Loteprednol Etabonate (FML) topical treatment 1 drop 4 times daily for 1 month” NCT02218827 ↗ |
| Known as | KPI-121 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03616899 ↗ |
| Known as | KPI-121 0.25% Ophthalmic Suspension | “KPI-121 0.25% Ophthalmic Suspension” NCT02163824 ↗ |
| Known as | Lot | “The patients were allocated equally into 2 groups by block randomization to receive either loteprednol etabonate (Lot) or dexamethasone (Dex) for 1 month after the surgery.” PMID 25555173 ↗ Jan 2015 |
| Known as | lotemax | “topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage” NCT01692652 ↗5“Loteprednol Etabonate Ophthalmic Gel [Lotemax]” NCT05542381 ↗ |
| Known as | Lotemax (loteprednol etabonate) 0.5% | “Lotemax (loteprednol etabonate) 0.5%” NCT02120079 ↗ |
| Known as | Lotemax Gel | “Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\])” NCT03063489 ↗1“Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%)” NCT02028312 ↗ |
| Modality | Other / unclassified | “loteprednol etabonate (LE), a C-20 ester-based corticosteroid” PMID 22627057 ↗ May 2012 |
| Route | Other | “loteprednol etabonate ophthalmic suspension 0.5%” NCT00366691 ↗ |