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, Adalimumab |
| ANI Pharmaceuticals, Inc. | ANIP | 1 | PHASE3 | Yutiq Drug |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
CLS-TA Suprachoroidal is an investigational small molecule being developed for the treatment of uveitis, including non-infectious uveitis. It is administered by suprachoroidal injection and is currently in Phase 3 clinical development for this ophthalmologic condition.
CLS-TA Suprachoroidal is being developed by Clearside Biomedical, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLSD. The company is conducting clinical trials to evaluate the drug for the treatment of uveitis.
CLS-TA Suprachoroidal is in Phase 3 clinical development for the treatment of uveitis. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 clinical trials have been completed to evaluate its safety and efficacy.
CLS-TA Suprachoroidal has been studied in two completed Phase 3 clinical trials. The first trial, NCT02595398, enrolled 160 participants with macular edema associated with non-infectious uveitis. The second trial, NCT03097315, enrolled 38 participants with non-infectious uveitis. Both trials were randomized, double-blind, and sham-controlled.
CLS-TA Suprachoroidal is the name used for the drug in its clinical development program. It is also referred to simply as CLS-TA in trial titles and descriptions. Both names refer to the same investigational small molecule being developed by Clearside Biomedical for uveitis.