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MGV354

Phase 1

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

MGV354 target and mechanism

ModalitySmall molecule

Also known as MGV354 ophthalmic suspension

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

MGV354 clinical trials

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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Frequently asked questions about MGV354

What is MGV354?

MGV354 is an investigational small molecule developed by Alcon Inc. (ticker ALC) as an ophthalmic suspension. It was studied for ocular hypertension and open-angle glaucoma, conditions in which pressure inside the eye is elevated. It is a Phase 1 candidate and is not an approved therapy.

What is MGV354 used for?

MGV354 was studied for ocular hypertension and open-angle glaucoma, eye conditions characterized by elevated intraocular pressure. It was administered as an ophthalmic suspension. Development reached Phase 1, and the compound remains investigational rather than an approved treatment for these indications.

Who makes MGV354?

MGV354 is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor behind the ophthalmic suspension program for ocular hypertension and open-angle glaucoma. The asset is an investigational small molecule that has completed a Phase 1 study.

What phase is MGV354 in?

MGV354 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. Because it is investigational, MGV354 is not an approved product for ocular hypertension or open-angle glaucoma, and further clinical development would be required before any regulatory review.

What clinical trials is MGV354 in?

MGV354 has been evaluated in one completed Phase 1 trial, NCT02743780, titled A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma. The randomized, double-blind, placebo-controlled study enrolled 191 participants aged 18 years and older, including healthy volunteers, across ocular hypertension and open-angle glaucoma.

Is MGV354 the same as MGV354 ophthalmic suspension?

Yes. MGV354 ophthalmic suspension is the same asset as MGV354, referring to the formulation used in its clinical program. Alcon Inc. (ticker ALC) developed this small molecule as an eye drop suspension for ocular hypertension and open-angle glaucoma, and it completed a Phase 1 study.