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IBI-10090 · 2 trials · 3 indications
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.
| Arm | Type | Description |
|---|---|---|
| IBI-10090 low dose | EXPERIMENTAL | IBI-10090 low dose |
| IBI-10090 med dose | EXPERIMENTAL | IBI-10090 med dose |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Dose 1 | EXPERIMENTAL | - |
| Dose 2 | EXPERIMENTAL | - |
| Dose 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IBI-10090 | DRUG | - |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB). 2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intr...
IBI-10090 is an investigational small molecule being developed for the treatment of inflammation associated with cataract surgery. It is intended to address postoperative ocular inflammation in patients undergoing cataract procedures. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
IBI-10090 is being developed by Icon Plc, a company publicly traded under the ticker symbol ICLR. Icon Plc is conducting clinical trials to evaluate the safety and efficacy of IBI-10090 for inflammation associated with cataract surgery. The drug is currently in Phase 3 development.
IBI-10090 is currently in Phase 3 clinical development. It has completed a Phase 2 trial and a Phase 3 trial for inflammation associated with cataract surgery. The drug remains investigational and has not received FDA approval.
IBI-10090 has been studied in two completed clinical trials. NCT01606735 was a Phase 2 trial with 172 participants, and NCT02006888 was a Phase 3 trial with 394 participants. Both trials evaluated the drug for inflammation associated with cataract surgery in the United States.
IBI-10090 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for inflammation associated with cataract surgery. Clinical trials have been completed, but regulatory approval has not been granted.