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XEN63 Glaucoma Treatment System · 1 trial · 1 indication
IOP is a measurement of the fluid pressure inside the study eye. Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| XEN63 Ab Externo | EXPERIMENTAL | Participants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months. |
| XEN63 Ab Interno | EXPERIMENTAL | Participants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months. |
| Name | Type | Description |
|---|---|---|
| XEN63 Glaucoma Treatment System | DEVICE | Gel Stent |
Inclusion Criteria: * Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b) 1. That meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (IOP)-lowering medications, ...
XEN63 Glaucoma Treatment System is an investigational gel stent being studied for the treatment of Primary Open Angle Glaucoma in adult participants. It is currently in Phase 3 clinical development and is not yet approved by the FDA.
XEN63 Glaucoma Treatment System is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
XEN63 Glaucoma Treatment System is currently in Phase 3 clinical development. It is an investigational device and has not received FDA approval. The ongoing Phase 3 trial is actively recruiting participants in the United States.
XEN63 Glaucoma Treatment System is being evaluated in a Phase 3 clinical trial with the identifier NCT06822738. This study assesses adverse events and effectiveness of gel stent implantation using ab interno and ab externo approaches in adult participants with glaucoma.
Yes, XEN63 Glaucoma Treatment System is also referred to as XEN63. The device is a gel stent designed for implantation in the eye to treat Primary Open Angle Glaucoma. It is currently being studied in a Phase 3 clinical trial.