Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% · 1 trial · 1 indication
Determined by corneal fluorescein staining and the effectiveness endpoint will also be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis.
| Arm | Type | Description |
|---|---|---|
| Single arm active | EXPERIMENTAL | KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S) | DRUG | KIO-201 is a stand-alone drug therapy that acts as a barrier that minimizes mechanical lid friction and mechanically protects the ocular surface thereby reducing repeat injury and providing an environment that enables the body to repair the ocular surface whether the corneal epithelial defects are large or small. |
Inclusion Criteria: * Patients 18 years of age or older. * Patients with persistent corneal epithelial defects (PED) (Stage 1 and Stage 2 PED). * Patients with PED in one or both eyes, at least one eye meeting all study criteria. * Have PED of at least 2 weeks' duration refractory to one or more co...