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MGV354

Phase 1

Ocular Hypertension | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jul 2, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment191

FDA Designations

No designations recorded

Clinical trial landscape

MGV354 · 1 trial · 2 indications

Phase 1 1
NCT02743780A Three Part Study of MGV354 in Ocular Hypertension or GlaucomaOcular Hypertension
COMPLETED191 Analytics
PHASE1COMPLETED
A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8
Baseline, Day 8

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the five time points measured (8 AM, 10 AM, noon, 4 PM, and 8 PM). Baseline diurnal IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.

Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM
Baseline, Day 8

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.

Secondary Endpoints

Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration
Baseline, up to Day 9
Part 1: Maximum Observed Concentration [Cmax (ng/mL)]
Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose
Part 1: Time to Reach Maximum Concentration [Tmax (h)]
Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
MGV354EXPERIMENTALPart 3: MGV354 ophthalmic suspension, 1 drop in both eyes once per day for 7 days
PlaceboPLACEBO_COMPARATORPart 3: MGV354 placebo, 1 drop in both eyes once per day for 7 days

Interventions

NameTypeDescription
MGV354 ophthalmic suspensionDRUG -
MGV354 placeboDRUGInactive ingredients used as placebo comparator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Documented informed consent. * Part 1: 18 to 70 years of age; * Parts 2 and 3: 18 years of age or older; * Able to communicate well with the investigator and understand and comply with the requirements of the study; * Body Mass Index (BMI) between 18 and 39; * In case of conta...

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Competitive Landscape -Ocular Hypertension 8 trials

Frequently asked questions about MGV354

What is MGV354 used for?

MGV354 is an investigational small molecule being developed for ocular hypertension, a condition of elevated pressure inside the eye. It was studied in a Phase 1 clinical trial that also included patients with open-angle glaucoma. The drug is administered to lower intraocular pressure, though it remains in clinical development and is not yet approved.

Who makes MGV354?

MGV354 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a pharmaceutical company focused on eye care and ophthalmology products. The drug is currently in Phase 1 clinical development for ocular hypertension.

What phase is MGV354 in?

MGV354 is in Phase 1 clinical development. A Phase 1 trial of the drug has been completed, involving 191 participants. The drug is investigational and has not been approved by regulatory authorities. It is being studied for the treatment of ocular hypertension and open-angle glaucoma.

What clinical trials is MGV354 in?

MGV354 has one completed clinical trial registered under the identifier NCT02743780. The trial, titled 'A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma,' was a Phase 1, randomized, double-blind, placebo-controlled study that enrolled 191 participants aged 18 years and older.

Is MGV354 the same as any other drug?

MGV354 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a small molecule being developed by Alcon Inc. for ocular hypertension and open-angle glaucoma, and it is currently in Phase 1 clinical development.