Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bimatoprost Implant System (High Dose), Bimatoprost Implant System
Bimatoprost System · 3 trials · 3 indications
Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints
Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better
| Arm | Type | Description |
|---|---|---|
| Bimatoprost Implant System / IOL Combination | EXPERIMENTAL | - |
| Timolol Maleate Ophthalmic Solution 0.5% | ACTIVE_COMPARATOR | - |
| Bimatoprost Implant System (High Dose) / IOL Combination | EXPERIMENTAL | - |
| Bimatoprost Implant System (Low Dose) / IOL Combination | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bimatoprost Implant System | DRUG | Bimatoprost Implant System used in combination with the SpyGlass IOL |
| SpyGlass IOL | DEVICE | SpyGlass Intraocular Lens |
| Timolol Maleate Ophthalmic Solution, 0.5% | DRUG | Timolol Maleate Ophthalmic Solution, 0.5% BID |
| Commercial IOL | DEVICE | Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens |
| Bimatoprost Implant System (High Dose) | DRUG | Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL |
| Bimatoprost Implant System (Low Dose) | DRUG | Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL |
| Commercially Available Aspheric Monofocal Non-Yellow Chromophore IOL | DEVICE | Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens |
Inclusion Criteria: * Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension * Planned removal of cataract * Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception Exclusion Criteria: * ...
Bimatoprost System is an investigational small molecule being developed for use in cataract surgery. It is designed to be used in combination with the SpyGlass Intraocular Lens (IOL) to treat cataract, glaucoma, and ocular hypertension. The drug is currently in Phase 3 clinical development.
Bimatoprost System targets the prostaglandin F2-alpha receptor (PTGFR), acting as an agonist. This mechanism is intended to lower intraocular pressure in patients undergoing cataract surgery with the SpyGlass Intraocular Lens. The drug is being evaluated for its ability to manage glaucoma and ocular hypertension in this setting.
Bimatoprost System is being developed by SpyGlass Pharma, Inc., a company traded under the ticker symbol SGP. The company is conducting clinical trials to evaluate the drug's safety and efficacy in combination with its SpyGlass Intraocular Lens for patients with cataract, glaucoma, and ocular hypertension.
Bimatoprost System is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 3 program includes two active trials, Rhine and Rhone, which are recruiting patients to compare the Bimatoprost Implant System with the SpyGlass IOL against timolol ophthalmic solution.
Bimatoprost System is being studied in three active clinical trials. NCT06120842 is a Phase 1 study with 201 participants. NCT07218783 (Rhine) and NCT07218796 (Rhone) are Phase 3 trials, each enrolling 400 participants. All trials are active in the United States and compare the implant system with timolol ophthalmic solution.
Yes, Bimatoprost System is also known as Bimatoprost Implant System, including the High Dose version. These names refer to the same investigational drug-device combination being developed by SpyGlass Pharma for use with the SpyGlass Intraocular Lens in cataract surgery patients with glaucoma or ocular hypertension.