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Also known as tabirafusp alfa
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 the treatment of macular edema secondary to inflammation (MESI), a condition affecting the retina. It is administered via intravitreal injection and is currently in Phase 3 clinical trials.
KSI-101 targets IL-6 and VEGF, two proteins involved in inflammation and blood vessel growth. By inhibiting these targets, the drug aims to reduce retinal swelling and improve vision in patients with macular edema secondary to inflammation.
KSI-101 is being developed by Kodiak Sciences Inc (NASDAQ: KOD), a biopharmaceutical company focused on treatments for eye diseases. The company is currently conducting Phase 3 trials to evaluate the drug's safety and efficacy.
KSI-101 is in Phase 3 clinical development. It is not yet approved by the FDA and remains investigational. Two Phase 3 trials, PINNACLE and PEAK, are currently recruiting participants to assess the drug for macular edema secondary to inflammation.
KSI-101 is being studied in two Phase 3 trials: PINNACLE (NCT06996080) with 300 participants and PEAK (NCT06990399) with 600 participants. Both are randomized, double-blind, sham-controlled studies enrolling adults in the United States and Puerto Rico.
KSI-101 is a distinct investigational drug that uniquely targets both IL-6 and VEGF. It is not known to be the same as any other approved medication. Its dual-target mechanism may differentiate it from existing therapies for macular edema secondary to inflammation.