Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLG561 · 2 trials · 2 indications
A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted.
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.
BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.
A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.
| Arm | Type | Description |
|---|---|---|
| CLG561 | EXPERIMENTAL | CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections |
| CLG561+LFG316 | EXPERIMENTAL | CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections |
| Sham Injection | SHAM_COMPARATOR | One sham injection every 28 days for total of 12 sham injections |
| CLG561, Concentration Level A | EXPERIMENTAL | Single 50 μL intravitreal injection of CLG561, Dose Level A |
| CLG561, Concentration Level B | EXPERIMENTAL | Single 50 μL intravitreal injection of CLG561, Dose Level B |
| CLG561, Concentration Level C | EXPERIMENTAL | Single 50 μL intravitreal injection of CLG561, Dose Level C |
| CLG561, Concentration Level D | EXPERIMENTAL | Single 50 μL intravitreal injection of CLG561, Dose Level D |
| CLG561, Concentration Level E | EXPERIMENTAL | Single 100 μL intravitreal injection of CLG561, Dose Level E |
| Name | Type | Description |
|---|---|---|
| CLG561 | DRUG | - |
| LFG316 | DRUG | - |
| Sham injection | DRUG | Empty syringe (without a needle) placed against the eye |
Inclusion Criteria: * Sign written informed consent form; * Geographic atrophy in both eyes; * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Pregnant or lactating women and women of child-bearing potential; * Any medical condition (systemic or ophthalmic) that may p...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 2 | PHASE3 | Vonaprument (ANX007) |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Genentech, Inc. | RHHBY | 1 | PHASE2 | OpRegen |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
CLG561 is an investigational small molecule being developed by Alcon Inc. for geographic atrophy and age-related macular degeneration, which are progressive eye diseases that can lead to vision loss. It is currently in clinical development and has not been approved by the FDA.
CLG561 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device company specializing in eye care products and treatments.
CLG561 is in Phase 1 clinical development. It has completed a Phase 1 pharmacokinetics study and a Phase 2 proof-of-concept study, both of which are finished. The drug remains investigational and is not yet approved for commercial use.
CLG561 has been studied in two completed clinical trials. NCT01835015 was a Phase 1 pharmacokinetics study in patients with advanced age-related macular degeneration. NCT02515942 was a Phase 2 proof-of-concept study as a monotherapy and in combination with LFG316 in subjects with geographic atrophy.
No, CLG561 is not the same as LFG316. In a clinical trial, CLG561 was studied as a monotherapy and in combination with LFG316, which is a separate investigational drug. The two agents were tested together to evaluate their combined effect in treating geographic atrophy.