Overview
Loteprednol Etabonate (LE) is a topical corticoid anti-inflammatory. It is used in ophthalmic solution for the treatment of steroid responsive inflammatory conditions of the eye such as allergic conjunctivitis, uveitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitides. As a nasal spray, it can be used for the treatment and management of seasonal allergic rhinitis. Most prescription LE products, however, tend to be indicated for the treatment of post-operative inflammation and pain following ocular surgery . A number of such new formulations that have been approved include Kala Pharmaceutical's Inveltys - the first twice-daily (BID) ocular corticosteroid approved for this indication, designed specifically to enhance patient compliance and simplified dosing compared to all other similar ocular steroids that are dosed four times daily . Moreover, LE was purposefully engineered to be a 'soft drug', one that is designed to be active locally at the site of administration and then rapidly metabolized to inactive components after eliciting its actions at the desired location, thereby subsequently minimizing the chance for adverse effects .
Indication
A number of prescription loteprednol etabonate ophthalmic products are specifically indicated for the treatment of post-operative inflammation and pain following ocular surgery .
Associated Conditions
- Dry Eye Syndrome (DES)
- Eye Pain
- Ocular Inflammation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/09/21 | Phase 4 | Completed | Thomas Chester, OD | ||
2017/04/04 | Phase 1 | Completed | |||
2014/06/16 | Phase 3 | Completed | |||
2014/01/07 | Phase 4 | Withdrawn | Edward Holland, MD | ||
2013/05/15 | Phase 4 | Completed | |||
2012/11/12 | Phase 4 | Completed | |||
2011/11/21 | Phase 3 | Completed | |||
2011/09/29 | Phase 4 | Completed | Southern California College of Optometry at Marshall B. Ketchum University | ||
2011/09/21 | Phase 4 | Completed | |||
2010/02/02 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Bausch & Lomb Incorporated | 24208-508 | OPHTHALMIC | 5 mg in 1 g | 3/31/2021 | |
Oceanside Pharmaceuticals | 68682-299 | OPHTHALMIC | 5 mg in 1 mL | 5/1/2020 | |
ALCON LABORATORIES, INC. | 71571-333 | OPHTHALMIC | 2.5 mg in 1 mL | 11/1/2023 | |
Amneal Pharmaceuticals NY LLC | 60219-1362 | OPHTHALMIC | 5 mg in 1 mL | 5/21/2025 | |
ALCON LABORATORIES, INC. | 71571-121 | TOPICAL | 10 mg in 1 mL | 3/29/2024 | |
Physicians Total Care, Inc. | 54868-4278 | OPHTHALMIC | 5 mg in 1 mL | 3/25/2011 | |
Bausch & Lomb Incorporated | 24208-358 | OPHTHALMIC | 5 mg in 1 mL | 4/30/2022 | |
Akorn | 50383-265 | OPHTHALMIC | 5 mg in 1 mL | 3/15/2022 | |
Bausch & Lomb Incorporated | 24208-507 | OPHTHALMIC | 3.8 mg in 1 g | 3/17/2023 | |
Physicians Total Care, Inc. | 54868-4277 | OPHTHALMIC | 2 mg in 1 mL | 9/10/2012 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
ZYLET® STERILE OPHTHALMIC SUSPENSION | SIN13647P | SUSPENSION, STERILE | 5 mg/ ml | 5/4/2009 | |
LOTEMAX STERILE OPHTHALMIC SUSPENSION 0.5% | SIN12601P | SOLUTION | 5 mg/ml | 10/13/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Lotemax loteprednol etabonate 0.5% eye drop suspension | 202525 | Medicine | A | 1/16/2014 |
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