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Label indication VYZULTA ® (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 ) FDA label
Also known as BOL-303259-X
Latanoprostene bunod · 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 5 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Travoprost |
| SpyGlass Pharma, Inc. | SGP | 5 | PHASE3 | Bimatoprost System, BIM-DRS |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | AGN-193408 |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | REGN22530 |
Latanoprostene bunod is an ophthalmic solution developed for lowering intraocular pressure in patients with glaucoma and ocular hypertension. It is studied as a topical eye drop therapy in the ophthalmology field, with clinical trials enrolling subjects with open-angle glaucoma or ocular hypertension.
Latanoprostene bunod is a small molecule agonist of PTGFR, the prostaglandin F receptor. By activating this receptor, it is designed to increase aqueous humor outflow from the eye, which reduces intraocular pressure. This mechanism underlies its investigation for glaucoma and ocular hypertension.
Latanoprostene bunod is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is responsible for the clinical program evaluating the ophthalmic solution in glaucoma and intraocular pressure indications.
Latanoprostene bunod has completed Phase 3 clinical development. A Phase 3 trial (NCT01895972) evaluated the long-term safety of the 0.024% ophthalmic solution in Japanese subjects with open-angle glaucoma or ocular hypertension, and it is now completed.
Latanoprostene bunod has been studied in two completed trials: NCT01895985, a Phase 1 study of intraocular pressure lowering in healthy Japanese male volunteers, and NCT01895972, a Phase 3 long-term safety study in Japanese subjects with open-angle glaucoma or ocular hypertension.
Latanoprostene bunod is an investigational therapy that has completed Phase 3 clinical trials. It has been evaluated for glaucoma and intraocular pressure reduction, but the available development information does not indicate regulatory approval status.