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Loteprednol etabonate

Generic Name
Loteprednol etabonate
Brand Names
Eysuvis, Inveltys, Lotemax
Drug Type
Small Molecule
Chemical Formula
C24H31ClO7
CAS Number
82034-46-6
Unique Ingredient Identifier
YEH1EZ96K6

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Withdrawn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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