Recent Updates
Recently added Catalysts

Latanoprostene bunod

Phase 3

Glaucoma | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Jul 26, 2018

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

Latanoprostene bunod · 2 trials · 3 indications

Phase 3 1Phase 1 1
NCT01895972Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHTGlaucoma
COMPLETED130 Analytics
PHASE3COMPLETED
Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Intraocular Pressure
Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52

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.

Clinical Safety
1 year

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.

intraocular pressure (IOP)
Visit 3 (Day 14/15)

Efficacy of latanoprostene bunod dosed QD in reducing IOP from baseline. IOP to be measured at multiple time points at visit 3.

Secondary Endpoints

Blood levels following a single dose
12 hours
Blood levels following multiple dosing
14 days
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Latanoprostene BunodEXPERIMENTALLatanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.

Interventions

NameTypeDescription
Latanoprostene bunodDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Latanoprostene bunod

What is Latanoprostene bunod used for?

Latanoprostene bunod is an investigational small molecule being developed for lowering intraocular pressure in patients with glaucoma and ocular hypertension. It is administered as an ophthalmic solution and is currently in Phase 3 clinical development for these conditions.

Who makes Latanoprostene bunod?

Latanoprostene bunod is being developed by Bausch + Lomb Corporation, which trades under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating elevated intraocular pressure associated with glaucoma.

What phase is Latanoprostene bunod in?

Latanoprostene bunod is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its long-term safety in patients with open-angle glaucoma or ocular hypertension.

What clinical trials is Latanoprostene bunod in?

Latanoprostene bunod has been studied in clinical trials registered under NCT01895972 and NCT01895985. The Phase 3 trial NCT01895972 evaluated long-term safety in 130 Japanese subjects with glaucoma or ocular hypertension, while the Phase 1 trial NCT01895985 assessed efficacy in healthy male volunteers.

How does Latanoprostene bunod work?

Latanoprostene bunod is a small molecule that works by targeting the prostaglandin pathway to lower intraocular pressure. It is designed to reduce pressure in the eye, which is a key factor in managing glaucoma and ocular hypertension.