Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KSI-101 · 2 trials · 1 indication
Mean change in BCVA from Day 1 to the average of Week 20 and Week 24.
| Arm | Type | Description |
|---|---|---|
| KSI-101 5 mg | EXPERIMENTAL | Intravitreal injection of KSI-101 5 mg once every 4 weeks for 6 monthly doses followed by individualized dosing |
| KSI-101 10 mg | EXPERIMENTAL | Intravitreal injection of KSI-101 10 mg once every 4 weeks for 6 monthly doses followed by individualized dosing |
| Sham | SHAM_COMPARATOR | Sham injection once every 4 weeks for 6 monthly doses followed by individualized sham dosing |
| Name | Type | Description |
|---|---|---|
| KSI-101 | DRUG | Intravitreal injection |
| Sham Comparator | OTHER | Sham injections |
Inclusion Criteria: * Macular Edema Secondary to Inflammation (MESI) with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye. * Definitive presence of Intraretinal Fluid and/or Subretinal Fluid on SD-OCT in the Study Eye. * BCVA ETDRS score of ≥25 and ≤70 letters (between 20/...
KSI-101 is an investigational small molecule being developed for macular edema secondary to inflammation (MESI), a condition in ophthalmology. It is administered via intravitreal injection. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
KSI-101 is being developed by Kodiak Sciences Inc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol KOD. The company is conducting Phase 3 clinical trials to evaluate the efficacy and safety of KSI-101 in patients with macular edema secondary to inflammation.
KSI-101 is in Phase 3 clinical development. Two Phase 3 trials, PEAK and PINNACLE, are currently recruiting participants. KSI-101 is an investigational drug and has not been approved by the FDA or any other regulatory agency.
KSI-101 is being evaluated in two Phase 3 trials: NCT06990399 (PEAK), with 600 participants, and NCT06996080 (PINNACLE), with 300 participants. Both are randomized, double-blind, sham-controlled studies enrolling adults aged 18 years and older in the United States and Puerto Rico.
No alternative names for KSI-101 have been reported. It is a distinct investigational small molecule developed by Kodiak Sciences Inc for the treatment of macular edema secondary to inflammation.