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Also known as Dexycu
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, specifically inflammation associated with cataract surgery. It is intended for use in patients undergoing ocular surgery to manage postoperative inflammation.
IBI-10090 is being developed by Icon Plc, a company listed on the NASDAQ under the ticker symbol ICLR. The drug is currently in Phase 3 clinical development for inflammation associated with cataract surgery.
IBI-10090 is in Phase 3 clinical development. It has completed a Phase 2 trial and a Phase 3 trial for inflammation associated with cataract surgery, both of which were conducted in the United States.
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 efficacy and safety of IBI-10090 for inflammation associated with cataract surgery.
IBI-10090 is not FDA approved. It is an investigational drug that has completed clinical trials but remains in clinical development. Its safety and efficacy have not yet been established for regulatory approval.