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OMS103HP-S · 1 trial · 1 indication
To evaluate the effect of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on knee symptoms as measured by the KOOS Symptoms subscale through Day 30.
To evaluate the safety of OMS103HP-S compared to vehicle when administered in joint irrigation fluid during arthroscopic meniscectomy on safety as measured by adverse events.
| Arm | Type | Description |
|---|---|---|
| OMS103HP-S | EXPERIMENTAL | OMS103HP-S injected into vehicle irrigation solution for administration during meniscectomy surgery |
| Vehicle Irrigation Solution | PLACEBO_COMPARATOR | Vehicle Irrigation Solution |
| Name | Type | Description |
|---|---|---|
| OMS103HP-S | DRUG | Proprietary concentration and formulation of OMS103HP in solution (OMS103HP-S) for injection into each 3 liter vehicle irrigation solution bag for use during meniscectomy surgery |
| Vehicle | DRUG | 3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery |
Inclusion Criteria: 1. Voluntarily provide written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if local...
OMS103HP-S is an investigational small molecule being developed for meniscal tear. It is administered in a joint irrigation solution to subjects undergoing arthroscopic meniscectomy, a surgical procedure to repair a torn meniscus in the knee.
OMS103HP-S is being developed by Omeros Corporation, a biopharmaceutical company traded on NASDAQ under the ticker OMER.
OMS103HP-S is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA.
OMS103HP-S has one completed Phase 3 clinical trial, NCT01406561, which evaluated its safety and efficacy in 344 subjects undergoing arthroscopic meniscectomy for meniscal tear. The trial was randomized, double-blind, and placebo-controlled, and was conducted in the United States.
OMS103HP-S is administered in a joint irrigation solution. It is delivered directly to the knee joint during arthroscopic meniscectomy, a surgical procedure for meniscal tear.