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KPI-121 · 3 trials · 4 indications
| Name | Type | Description |
|---|---|---|
| KPI-121 Ophthalmic Suspension | DRUG | KPI-121 Ophthalmic Suspension |
| Vehicle | DRUG | Vehicle for KPI-121 0.25% ophthalmic suspension |
| KPI-121 | DRUG | KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
| Placebo | DRUG | Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate. |
KPI-121 is an investigational small molecule being developed for ophthalmology conditions, including keratoconjunctivitis sicca, dry eye syndromes, and blepharitis. It is being studied for its safety and efficacy in treating these eye conditions.
KPI-121 is being developed by KALA BIO, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy for dry eye disease and related inflammatory conditions.
KPI-121 has completed Phase 2 and Phase 3 clinical trials. The Phase 3 trial, NCT03616899, evaluated the drug in 901 subjects with keratoconjunctivitis sicca. The drug is investigational and has not been approved by regulatory authorities.
KPI-121 has completed three clinical trials: NCT02188160 and NCT02218489, both Phase 2 studies, and NCT03616899, a Phase 3 study. These trials evaluated the drug in subjects with dry eye disease, inflammatory meibomian gland disease, and keratoconjunctivitis sicca.
KPI-121 is a distinct investigational drug candidate developed by KALA BIO, Inc. It is not known to be the same as any other marketed or approved medication. Its unique formulation is being studied specifically for dry eye and blepharitis indications.