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CLS-TA Suprachoriodal

Phase 3

Uveitis | Small molecule | Ophthalmology |Clearside Biomedical, Inc.|Last Updated: Jun 23, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindSHAM_CONTROLLEDBiomarker
Total Trials2
Total Enrollment198
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03097315Suprachoroidal Injection of CLS-TA in Patients With Non-infectious UveitisPHASE3 COMPLETED 38Apr 4, 2017Jan 24, 2018Jun 23, 202110 United States
NCT02595398Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious UveitisPHASE3 COMPLETED 160Nov 17, 2015Jan 18, 2018May 28, 202164 United States, India +1
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Study Endpoints
Primary Endpoints
Adverse Events
Baseline to 24 weeks

Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.

Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
Baseline, 24 weeks

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

Secondary Endpoints
Mean Intraocular Pressure in the Study Eye
Baseline, 24 Weeks
Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye
Baseline, 24 Weeks
Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye
Baseline, 24 Weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
4 mg CLS-TA Suprachoriodal InjectionEXPERIMENTALSuprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA
4mg CLS-TA Suprachoriodal InjectionEXPERIMENTALSuprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Sham ProcedureSHAM_COMPARATORMatching suprachoroidal syringe with sham procedure
Interventions
NameTypeDescription
4 mg CLS-TA Suprachoriodal InjectionDRUGCLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
4mg CLS-TA Suprachoriodal InjectionDRUGCLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Sham ProcedureDRUGSham procedure administered at 2 timepoints
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior) * ETDRS BCVA score of ≥ 5 letters read in the study eye Exclusion Criteria: * Any active ocular disease or infection in the study eye other than uveitis * Intraocular pressure ...

Countries:United StatesIndiaIsrael
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