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Also known as ESBA105 ophthalmic solution
ESBA105 · 1 trial · 1 indication
An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
| Arm | Type | Description |
|---|---|---|
| ESBA105 | EXPERIMENTAL | ESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks |
| Vehicle | PLACEBO_COMPARATOR | ESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks |
| Name | Type | Description |
|---|---|---|
| ESBA105 ophthalmic solution | BIOLOGICAL | - |
| ESBA105 vehicle | OTHER | Inactive ingredients used as Run-In and placebo comparator |
Inclusion Criteria: * Ongoing physician diagnosis of dry eye for at least 6 months. * Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis. * Experience persistent ocular discomfort. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Contact ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
ESBA105 is an investigational monoclonal antibody developed by Alcon Inc. (ticker ALC) as an ophthalmic solution for chronic dry eye. It is a Phase 2 clinical-stage candidate in ophthalmology and has not been approved for commercial use. Alcon is also known as ESBA105 ophthalmic solution.
ESBA105 is being studied for the treatment of chronic dry eye, also described as Eyes Dry Chronic, in the ophthalmology therapeutic area. It is formulated as an ophthalmic solution. The program remains investigational, so ESBA105 is not an approved therapy for dry eye or any other condition.
Alcon Inc., which trades under the ticker ALC, is the developer of ESBA105. The company is advancing the monoclonal antibody ophthalmic solution as a clinical-stage asset in its ophthalmology pipeline. Alcon is the sole developer named for this program.
ESBA105 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. Because the program has not completed later-stage development, ESBA105 is investigational and has not received FDA approval for chronic dry eye or any other indication.
ESBA105 has been evaluated in one completed Phase 2 trial, NCT01338610, titled ESBA105 in Patients With Severe Dry Eye. That randomized, double-blind, placebo-controlled study enrolled 334 participants aged 18 years and older in the United States. No ESBA105 trials are currently active.
Yes. ESBA105 ophthalmic solution is an alternative name for ESBA105, the monoclonal antibody developed by Alcon Inc. for chronic dry eye. Both names refer to the same Phase 2 investigational asset, which was studied in the completed trial NCT01338610.