Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLS-AX · 2 trials · 1 indication
Best Corrected Visual Acuity (BCVA) letter score measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable). An increase in BCVA letter score from baseline indicates an improvement in visual acuity.
Number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.
Number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.
| Arm | Type | Description |
|---|---|---|
| 1.0 mg CLS-AX | EXPERIMENTAL | Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX |
| Aflibercept | ACTIVE_COMPARATOR | Intravitreal injection of aflibercept (2 mg in 0.05 mL) |
| Cohort 1 (Low Dose) | EXPERIMENTAL | Subjects will receive a low dose of 0.03 mg CLS-AX |
| Cohort 2 (Low-mid Dose) | EXPERIMENTAL | Subjects will receive a low-mid dose of 0.10 mg CLS-AX |
| Cohort 3 (High-mid Dose) | EXPERIMENTAL | Subjects will receive a high-mid dose of 0.50 mg CLS-AX |
| Cohort 4 (High Dose) | EXPERIMENTAL | Subjects will receive a high-mid dose of 1.0 mg CLS-AX |
| Name | Type | Description |
|---|---|---|
| CLS-AX | DRUG | CLS-AX will be administered by suprachoroidal injection into the study eye on Day 1 and then every 12 to 24 weeks as determined by protocol-defined disease activity criteria. |
| Aflibercept | DRUG | Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W). |
| Anti-VEGF | DRUG | Standard of care therapy used to block vascular endothelial growth factor |
Key Inclusion Criteria: * Diagnosis of neovascular age-related macular degeneration (nAMD) in the study eye within 36 months of Visit 1. * Subfoveal choroidal neovascularization (CNV) secondary to nAMD of any lesion type in the study eye that shows total lesion area ≤30 mm2, CNV component area of ≥...
CLS-AX is an investigational small molecule being developed for the treatment of neovascular age-related macular degeneration (nAMD), a condition characterized by abnormal blood vessel growth in the eye. It is administered via suprachoroidal injection and is currently in Phase 2 clinical development.
The specific molecular target of CLS-AX has not been disclosed in available information. It is a small molecule designed for suprachoroidal administration in the eye, intended to treat neovascular age-related macular degeneration, but its precise mechanism of action is not publicly detailed.
CLS-AX is being developed by Clearside Biomedical, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CLSD. The company is focused on ophthalmology and is advancing CLS-AX through clinical trials for neovascular age-related macular degeneration.
CLS-AX is currently in Phase 2 clinical development. It has completed a Phase 1 safety and tolerability study and a Phase 2 efficacy study, both in patients with neovascular age-related macular degeneration. It is not yet approved by regulatory authorities.
CLS-AX has been studied in two completed clinical trials. NCT04626128 was a Phase 1 safety and tolerability study of suprachoroidal injection of CLS-AX following anti-VEGF therapy, enrolling 27 participants. NCT05891548 was a Phase 2 study evaluating suprachoroidally administered CLS-AX in neovascular AMD, enrolling 60 participants.
No alternative names for CLS-AX have been identified in available information. It is referred to solely as CLS-AX in clinical trial records and company communications, and no other drug names have been associated with this investigational agent.