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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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Timolol eye 0.5% |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Undisclosed |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System, Timolol, 0.5% |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 2 | PHASE3 | Test- Bimatoprost 0.01%, Reference- LUMIGAN |
| Alcon AG | ALC | 5 | N/A | Undisclosed |
| Sight Sciences, Inc. | SGHT | 3 | N/A | Undisclosed |
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 to be implanted to help reduce intraocular pressure. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
XEN45 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and effectiveness of this glaucoma treatment system in patients with different forms of glaucoma.
XEN45 is currently in Phase 3 clinical development. Two Phase 3 trials have been completed, one studying the treatment in patients with angle-closure glaucoma and another in patients with open-angle glaucoma. The drug remains investigational and has not received approval from regulatory agencies.
XEN45 has been studied in two completed Phase 3 clinical trials. The first, NCT03362931, evaluated the safety and effectiveness of the XEN45 glaucoma treatment system in patients with angle-closure glaucoma. The second, NCT05411198, assessed change in disease activity and adverse events of the XEN45 implantation in participants with open-angle glaucoma.
XEN45 is a glaucoma gel stent that is implanted into the eye to create a new drainage pathway for aqueous humor, thereby reducing intraocular pressure. This mechanism helps to manage glaucoma by improving fluid outflow and lowering pressure within the eye, which can help prevent damage to the optic nerve.