Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as latanoprostene bunod
BOL-303259-X · 6 trials · 5 indications
Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52.
Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with \>/=1 ocular AE Specifics of AEs are captured in the AE section.
Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost
Efficacy of latanoprostene bunod dosed QD in reducing IOP from baseline. IOP to be measured at multiple time points at visit 3.
| Arm | Type | Description |
|---|---|---|
| Latanoprostene Bunod | EXPERIMENTAL | Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period. |
| BOL-303259-X | EXPERIMENTAL | BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s). |
| Timolol | ACTIVE_COMPARATOR | Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s). |
| Timolol Maleate | ACTIVE_COMPARATOR | Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. |
| Latanoprost | ACTIVE_COMPARATOR | ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| Latanoprostene bunod | DRUG | - |
| BOL-303259-X | DRUG | Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6). |
| Timolol | DRUG | Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6) |
| Timolol maleate | DRUG | Topical ophthalmic solution |
| Latanoprost | DRUG | 0.005% ophthalmic solution, QD 28 days |
Inclusion Criteria: * Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma \[NTG\],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes. * Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day ...
Top 3 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular, high elution |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Bimatoprost ophthalmic solution |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | bimatoprost |
BOL-303259-X is an investigational small molecule being developed for the treatment of elevated intraocular pressure, ocular hypertension, and open-angle glaucoma. It is administered as an ophthalmic solution and is currently in clinical development, though it has not been approved by the FDA.
BOL-303259-X is being developed by Bausch + Lomb Corporation, a company traded on the stock exchange under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational ophthalmic treatment.
BOL-303259-X is in Phase 2 clinical development. Two Phase 2 trials have been completed, and the drug remains investigational. It has not received FDA approval and is still being studied for its potential use in treating glaucoma and ocular hypertension.
BOL-303259-X has been studied in two completed Phase 2 trials. NCT01223378 compared the drug to latanoprost in 413 subjects with glaucoma or ocular hypertension. NCT01707381 evaluated the drug in combination with timolol 0.5% in 25 subjects with open-angle glaucoma or ocular hypertension.
No, BOL-303259-X is a distinct investigational drug. In clinical trials, it has been compared against latanoprost and timolol, which are established treatments for glaucoma and ocular hypertension. The trials were designed to assess how BOL-303259-X compares to these existing therapies.