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Lotilaner

Phase 3FDA approved

Blepharitis | Small Molecules | Ophthalmology |LianBio|Trials Updated: May 21, 2024

Lotilaner development status

FDA approval on record Jul 24, 2023 as Xdemvy
Approval holderTarsus
ApplicationNDA217603
Highest phase Phase 3
Registered trials 5 across 2 sponsors since Jul 2020

Label indication XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis. ( 1 ) FDA label

Lotilaner target and mechanism

ModalitySmall Molecules

Also known as TP-03, S-Misoxam

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment163

FDA Designations

No designations recorded

Lotilaner clinical trials

Lotilaner · 1 trial · 1 indication

Phase 3 1
NCT05629390Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA StudyBlepharitis
COMPLETED163 Analytics
PHASE3COMPLETED
Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study
BlepharitisUnlock trial analytics

Study Endpoints

Primary Endpoints

The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye.
43 days

To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis

The proportion of participants with Demodex eradication based on the mite density of 0 mites/lash for the analysis eye at Day 43
43 days

To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis

The assessment of treatment-related adverse effects
43 days

To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis

Secondary Endpoints

The proportion of participants cured based on a composite of collarette score of 0 and erythema score of 0 for the upper eyelid of the analysis eye
43 days
Blood drug concentration of Lotilaner at Day 43
43 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lotilaner Ophthalmic Solution (TP-03)EXPERIMENTALLotilaner Ophthalmic Solution (TP-03)
Vehicle ControlPLACEBO_COMPARATORVehicle Control

Interventions

NameTypeDescription
LotilanerDRUGLotilaner Ophthalmic Solution
Vehicle ControlDRUGVehicle of TP-03 ophthalmic solution
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Male or female, aged ≥ 18 years of age. 2. Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol. 3. Has blepharitis 4. Stated willingness to comply with all study procedures and availability for the duration of th...

Countries:China
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Competitive Landscape -Blepharitis 2 trials

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Glaukos CorpGKOS1PHASE4GLK-321
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