Vyzulta

(Latanoprostene bunod)

ApprovedSmall molecule

BBausch Health Americas, Inc.

Vyzulta is one of 20 small molecule programs targeting Ocular Hypertension. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Ocular HypertensionActive, not recruiting

Ocular HypertensionApproved

Active, not recruiting

Competition

Competitive Landscape

187 competitors in Ocular Hypertension

#DrugCompanyPhaseTrials

Alphagan

Novartis

Phase 3

1 2

Timolol Maleate

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

9 3

Vyzulta

BBausch Health Americas, Inc.

Approved

1 4

Azopt

Novartis

Phase 3

1 5

Ocupress

AbbVie

Phase 3

1 6

LUMIGAN

AbbVie

Phase 3

2 7

Krytantek

AbbVie

Phase 3

2 8

Bimatoprost/timolol

AbbVie

Phase 3

4 9

Preservative-Free Tafluprost

Merck & Co.

Phase 3

2 10

Reference - LUMIGAN

AAmneal Pharmaceuticals, LLC

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Intraocular Pressure1 trial

Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers

Completed·BBausch & Lomb Incorporated·Phase 1·NCT01895985·24 enrolled

Ocular Hypertension1 trial

A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension

Withdrawn·BBausch & Lomb Incorporated·Phase 4·NCT04140279

Unspecified1 trial

Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01895972·130 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 2, 2017

VYZULTA

NDA NDA207795

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Latanoprostene bunod. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Latanoprostene bunod compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Latanoprostene bunod. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA207795). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vyzulta. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

Patent Landscape[5]

Patent Cliff

Feb 21, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8058467Feb 21, 2029

Vyzulta

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Intraocular Pressure1 trial

Ocular Hypertension1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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