Lotemax

(Loteprednol)

ApprovedSmall molecule

PPharmos

Lotemax is one of 64 small molecule programs targeting Myopia. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

MyopiaActive, not recruiting

BlepharitisActive, not recruiting

Sjogren SyndromeNot yet recruiting

MyopiaApproved

Active, not recruiting

BlepharitisApproved

Active, not recruiting

Sjogren SyndromePhase 2

Not yet recruiting

Competition

Competitive Landscape

58 competitors in Myopia

#DrugCompanyPhaseTrials

Atropen

FFresenius Kabi Oncology Ltd.

Approved

12 2

Alphagan

Isopto Carpine

Mitosol

Oxylone

1 6

Lucentis

Lotemax

1 8

Mydriacyl

FFalcon

Approved

1 9

Avastin

BBio-Thera Solutions

Phase 3

—10

Carboxymethylcellulose

AbbVie

Approved

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

Timeline

Expected Milestones

Q1 2028

Phase 2Not yet recruiting

Sjogren Syndrome

NCT07671222

Clinical

Trials by Indication[1]

Blepharitis1 trial

Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis

Completed·MMassachusetts Eye and Ear Infirmary·Phase 4·NCT01456780·60 enrolled

Myopia1 trial

Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study

Unknown status·—·Phase 4·NCT02974387·200 enrolled

Tolerance1 trial

Use of Loteprednol for Contact Lens Intolerance and Dryness

Unknown status·HHom, Milton M., OD, FAAO·Phase 4·NCT00817557·25 enrolled

Sjogren syndrome1 trial

Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease: Randomized Controlled Trial.

Not yet recruiting·IInstituto de Oftalmología Fundación Conde de Valenciana·Phase 2·NCT07671222·38 enrolled

Regulatory

FDA Approval Timeline[4]

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

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PPharmos

Patent Landscape[5]

Patent Cliff

May 3, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9056057May 3, 2033

9532955May 3, 2033

10058511May 3, 2033

9393213May 3, 2033

10646436May 3, 2033

18 more patents

11872318May 3, 2033

11219596May 3, 2033

11219597May 3, 2033

11596599May 3, 2033

10857096May 3, 2033

10864219May 3, 2033

10945948May 3, 2033

10940108May 3, 2033

9737491May 3, 2033

9827191May 3, 2033

10993908May 3, 2033

12115246May 3, 2033

10688045May 3, 2033

11642317May 3, 2033

10646437May 3, 2033

11534395Jan 26, 2036

12589069Jan 26, 2036

10596107Dec 23, 2036

Lotemax

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Blepharitis1 trial

Myopia1 trial

Tolerance1 trial

Sjogren syndrome1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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