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Also known as Gen 2 Travoprost Intracameral Implant
Gen 2 Travoprost Intracameral · 2 trials · 1 indication
Change from baseline in diurnal IOP in the study eye at 8am and 10am at each of Day 11, Week 6, and Month 3 visits
| Arm | Type | Description |
|---|---|---|
| Cohort X Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months |
| Cohort X Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months |
| Cohort Y Gen 2 Travoprost Intracameral Implant Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months |
| Cohort Y Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months |
| Cohort Z Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months |
| Cohort Z Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months |
| Period 1 (Cohort A) | EXPERIMENTAL | Single-arm, open-label portion of Phase 2; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months |
| Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled Phase 2 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months |
| Period 2 (Cohort B) Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 2 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and be followed for 36 months |
| Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months |
| Period 3 (Cohort X) Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months |
| Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months |
| Period 3 (Cohort Y) Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months |
| Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months |
| Period 3 (Cohort Z) Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months |
| Name | Type | Description |
|---|---|---|
| Gen 2 Travoprost Intracameral Implant | DRUG | Travoprost |
| Timolol eye drops 0.5% | DRUG | Timolol 0.5% |
| Sham Procedure | PROCEDURE | Sham implant administration |
| placebo eye drops | OTHER | Artificial Tears |
Inclusion Criteria: * Diagnosis of Ocular Hypertension or Open-Angle Glaucoma in the study eye Exclusion Criteria: * Prior incisional glaucoma surgery in the study eye * Prior argon laser trabeculoplasty (ALT) in the study eye * Prior minimally invasive glaucoma (MIGS) surgery in the study eye
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 5 | 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 | 1 | PHASE3 | Test- Bimatoprost 0.01%, Reference- LUMIGAN |
| Alcon AG | ALC | 5 | N/A | Undisclosed |
| Sight Sciences, Inc. | SGHT | 3 | N/A | Undisclosed |
Gen 2 Travoprost Intracameral is an investigational small molecule implant being developed for the treatment of glaucoma. It is administered intracamerally and is currently in Phase 3 clinical development. The drug is designed to deliver travoprost, a prostaglandin analog, directly into the eye to lower intraocular pressure.
Gen 2 Travoprost Intracameral targets the FP receptor, a prostaglandin F receptor involved in regulating intraocular pressure. By activating this receptor, the drug aims to increase aqueous humor outflow and reduce pressure within the eye, which is the primary goal in managing glaucoma.
Gen 2 Travoprost Intracameral is being developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker symbol GKOS. Glaukos specializes in ophthalmic medical technology and is advancing this intracameral implant through clinical trials for glaucoma.
Gen 2 Travoprost Intracameral is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with glaucoma.
Gen 2 Travoprost Intracameral is being studied in two active clinical trials. NCT07495852 is a Phase 3 trial with 510 participants, and NCT07075718 is a Phase 2/Phase 3 trial with 610 participants. Both trials are recruiting adults aged 18 and older with glaucoma in the United States.
Yes, Gen 2 Travoprost Intracameral is also known as Gen 2 Travoprost Intracameral Implant. The two names refer to the same investigational drug-device combination product being developed by Glaukos Corporation for the treatment of glaucoma.