Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLS-TA Suprachoriodal · 2 trials · 5 indications
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.
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.
| Arm | Type | Description |
|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | EXPERIMENTAL | Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA |
| 4mg CLS-TA Suprachoriodal Injection | EXPERIMENTAL | Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA |
| Sham Procedure | SHAM_COMPARATOR | Matching suprachoroidal syringe with sham procedure |
| Name | Type | Description |
|---|---|---|
| 4 mg CLS-TA Suprachoriodal Injection | DRUG | CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints |
| 4mg CLS-TA Suprachoriodal Injection | DRUG | CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints |
| Sham Procedure | DRUG | Sham procedure administered at 2 timepoints |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Roivant Sciences Ltd. | ROIV | 1 | PHASE3 | Brepocitinib |
| Eli Lilly and Company | LLY | 1 | PHASE3 | Baricitinib |
| ANI Pharmaceuticals, Inc. | ANIP | 1 | PHASE3 | Yutiq |
CLS-TA Suprachoroidal is an investigational small molecule therapy given as a suprachoroidal injection for non-infectious uveitis, an inflammatory eye condition. It is being developed by Clearside Biomedical, Inc. (ticker CLSD) and has been studied in Phase 3 clinical trials. It is not described as approved.
CLS-TA Suprachoroidal is being studied for the treatment of non-infectious uveitis, including posterior, anterior, intermediate, and panuveitis. One Phase 3 trial also evaluated it in macular edema associated with non-infectious uveitis. The drug remains investigational and is not described as approved for any indication.
CLS-TA Suprachoroidal is being developed by Clearside Biomedical, Inc., which trades under the ticker CLSD. The company is the sponsor of the clinical program evaluating the suprachoroidal injection in patients with non-infectious uveitis.
CLS-TA Suprachoroidal is in Phase 3 development. Two Phase 3 trials have been completed, and no active trials are listed. The program is investigational, and the drug is not described as FDA approved.
CLS-TA Suprachoroidal has been evaluated in two completed Phase 3 trials: NCT03097315, which studied suprachoroidal injection of CLS-TA in patients with non-infectious uveitis, and NCT02595398, which studied it in macular edema associated with non-infectious uveitis. Together the trials enrolled 198 participants.