Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BOL-303259-X · 4 trials · 4 indications
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
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes. * Participants must meet the following IOP requirements at Visit 3 * mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye * IOP ≤ 36 mmHg at all 3...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Test - Bimatoprost 0.01%, Reference - LUMIGAN |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | Bimatoprost |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Nicotinomide |
| Alcon AG | ALC | 3 | PHASE4 | Undisclosed |
BOL-303259-X is an investigational small molecule being developed for the treatment of ocular hypertension, open-angle glaucoma, and elevated intraocular pressure. It is administered as an ophthalmic solution and is currently in clinical development for these ophthalmologic conditions.
BOL-303259-X is being developed by Bausch + Lomb Corporation, which trades under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for glaucoma and ocular hypertension.
BOL-303259-X is in Phase 2 clinical development. It has completed two Phase 2 trials and two Phase 3 trials, but it remains investigational and has not been approved by regulatory authorities. The drug is still undergoing clinical evaluation for its intended indications.
BOL-303259-X has been studied in several completed trials. NCT01223378 compared it to latanoprost in 413 subjects with glaucoma or ocular hypertension. NCT01707381 evaluated it with timolol in 25 subjects. Two Phase 3 trials, NCT01749904 and NCT01749930, each enrolled 420 subjects comparing it to timolol maleate.
BOL-303259-X is a small molecule developed for ophthalmic use. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its ability to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.