Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
iStent Inject, Cataract Surgery · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cataract Surgery Only | ACTIVE_COMPARATOR | - |
| Treatment with Cataract Surgery & Stents | EXPERIMENTAL | Ab interno trabecular micro-bypass stent surgery |
| Name | Type | Description |
|---|---|---|
| iStent Inject (GTS400) | DEVICE | Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents. |
| Cataract Surgery | PROCEDURE | Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only. |
Inclusion Criteria: * Diagnosed with open-angle glaucoma in the study eye * Subject must be on 1 to 3 glaucoma medications * Subject able and willing to attend follow up visits for two years postop * Subject able and willing to sign informed consent Exclusion Criteria: * Pseudoexfoliative and pig...
| 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 |
iStent Inject is an investigational device used to lower intraocular pressure in patients with open-angle glaucoma. It is implanted during cataract surgery to improve aqueous humor outflow. The device is being studied in a Phase 3 clinical trial, and it is not yet approved by the FDA.
iStent Inject is developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker GKOS. Glaukos specializes in micro-invasive glaucoma surgery devices. The company is conducting clinical trials to evaluate the safety and effectiveness of iStent Inject in patients with glaucoma.
iStent Inject is in Phase 3 clinical development. A Phase 3 trial, NCT01052558, has been completed with 164 participants. The trial evaluated the device in patients with open-angle glaucoma undergoing cataract surgery. iStent Inject remains investigational and has not received FDA approval.
iStent Inject has one completed Phase 3 clinical trial, NCT01052558, titled "GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma." The study enrolled 164 participants in the United States and was active-controlled, meaning it compared the device against an alternative treatment.
iStent Inject is not FDA approved. It is an investigational device currently in Phase 3 clinical development. A completed Phase 3 trial, NCT01052558, has evaluated its use in glaucoma patients undergoing cataract surgery, but regulatory approval has not been granted.