Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL-78898A · 1 trial · 1 indication
The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.
An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.
| Arm | Type | Description |
|---|---|---|
| AL-78898A | EXPERIMENTAL | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
| Lucentis | ACTIVE_COMPARATOR | Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up |
| Name | Type | Description |
|---|---|---|
| AL-78898A | DRUG | Investigational treatment |
| Ranibizumab | DRUG | Anti-vascular endothelial growth factor (VEGF) treatment |
Inclusion Criteria: * Willing to give informed consent, make the required study visits and follow instructions; * Newly diagnosed with exudative age-related macular degeneration (AMD); * Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye); * Best-...
AL-78898A is an investigational small molecule developed by Alcon Inc. (ticker ALC) for exudative age-related macular degeneration, a form of wet AMD. It is a complement C3 inhibitor and has been studied in a Phase 2 clinical trial. It is not described as approved and remains an investigational agent in clinical development.
AL-78898A was studied for the treatment of exudative age-related macular degeneration, also known as wet AMD, in adults aged 50 years and older. The Phase 2 trial evaluated the drug in this ophthalmology indication. It is an investigational therapy and is not described as approved for any use.
AL-78898A targets complement component 3, or C3. It is classified as a C3 inhibitor, meaning it acts on the complement pathway by inhibiting C3. This small molecule mechanism was the basis for its evaluation in exudative age-related macular degeneration, a condition in which complement activation is thought to play a role.
AL-78898A is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program for this investigational small molecule in ophthalmology. The drug has been evaluated in a Phase 2 trial for exudative age-related macular degeneration.
AL-78898A is in Phase 2 development. Its single clinical trial, NCT01157065, was a Phase 2 study that has been completed. No active trials are listed, and the drug is not described as FDA approved. It remains an investigational small molecule for exudative age-related macular degeneration.
AL-78898A has been studied in one clinical trial, NCT01157065, titled Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration. This completed Phase 2 trial enrolled 99 participants in the United States, was randomized, double blind, and used an active control. Participants were 50 years or older.