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XEN45 · 2 trials · 3 indications
Effectiveness is defined as achieving 20% or more reduction of intraocular pressure (IOP) from baseline and on the same or fewer number of glaucoma medications than at baseline without secondary surgical intervention for IOP (SSII).
IOP will be measured using a Goldmann applanation tonometer
| Arm | Type | Description |
|---|---|---|
| XEN45 (Glaucoma Gel Stent) | EXPERIMENTAL | Participants will receive XEN45 implanted using an ab externo approach on Day 1. |
| XEN45 Glaucoma Treatment System (hereafter referred to as XEN) | EXPERIMENTAL | XEN45 unilaterally implanted in the study eye |
| Name | Type | Description |
|---|---|---|
| XEN45 (Glaucoma Gel Stent) | DEVICE | Ab externo implant |
| XEN45 | DEVICE | XEN45 unilaterally implanted in the study eye |
Inclusion Criteria: * Glaucoma in the study eye. 1. Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy 2. Study eye that meet at least one of the following criteria: * Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery...
Top 5 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Travoprost |
| SpyGlass Pharma, Inc. | SGP | 5 | PHASE3 | Bimatoprost System, BIM-DRS |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | AGN-193408 |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | REGN22530 |
XEN45 is an investigational glaucoma treatment system being studied for use in patients with open-angle glaucoma and angle-closure glaucoma. It is a gel stent designed for implantation to help manage intraocular pressure in these conditions. The drug is currently in Phase 3 clinical development.
XEN45 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is conducting Phase 3 clinical trials to evaluate the safety and effectiveness of the XEN45 glaucoma treatment system.
XEN45 is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. Two Phase 3 trials have been completed to assess its safety and effectiveness in patients with glaucoma.
XEN45 has been studied in two completed Phase 3 clinical trials. NCT03362931 evaluated its safety and effectiveness in patients with angle-closure glaucoma, enrolling 65 participants across Australia, Canada, Singapore, South Korea, Taiwan, and the United Kingdom. NCT05411198 assessed disease activity and adverse events in 74 participants aged 45 years or older with open-angle glaucoma in the United States and Australia.
XEN45 is a glaucoma gel stent that is implanted into the eye to create a drainage pathway for aqueous humor, thereby reducing intraocular pressure. It is designed to be placed using an ab externo approach, as studied in clinical trials for open-angle glaucoma.