Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EM-100 · 1 trial · 1 indication
Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.
| Arm | Type | Description |
|---|---|---|
| EM-100 | EXPERIMENTAL | One drop of EM-100 in either the right or left eye once on Day 1. |
| Zaditor® | EXPERIMENTAL | One drop of Zaditor® in either the right or left eye once on Day 1. |
| Vehicle | EXPERIMENTAL | One drop of Vehicle in either the right or left eye once on Day 1. |
| Name | Type | Description |
|---|---|---|
| EM-100 | DRUG | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
| Zaditor® | DRUG | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
| Vehicle | DRUG | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
Inclusion Criteria: * be at least 18 years old * have a positive history of allergic conjunctivitis and positive skin test reaction to allergens * be willing to avoid disallowed medications for the appropriate washout period and throughout the trial * be willing to avoid contact lens use * be willi...
EM-100 is an investigational small molecule being developed for the treatment of allergic conjunctivitis, a condition that causes redness, itching, and swelling of the eye due to an allergic reaction. It is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.
EM-100 is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. Bausch + Lomb is a global eye health company focused on vision care products and ophthalmic pharmaceuticals.
EM-100 is in Phase 3 clinical development for allergic conjunctivitis. It has completed one Phase 3 trial, and it remains an investigational drug, meaning it has not received regulatory approval and is still undergoing clinical evaluation to establish its safety and efficacy.
EM-100 has one completed clinical trial registered under NCT03489941. This was a Phase 3, single-center, randomized, double-blind, controlled study conducted in the United States that enrolled 65 adults aged 18 years and older with allergic conjunctivitis. The trial compared EM-100 against Zaditor (ketotifen fumarate ophthalmic solution 0.035%) and a vehicle control.
No, EM-100 is not the same as Zaditor. Zaditor is a brand name for ketotifen fumarate ophthalmic solution 0.035%, an antihistamine and mast cell stabilizer used to treat itchy eyes. In clinical trials, EM-100 has been compared against Zaditor as an active comparator to evaluate its relative efficacy, but they are distinct drug products.