What is the mechanism of action of this treatment?

Common treatments for Presbyopia, such as Brimonidine and Carbachol, work through distinct mechanisms. Brimonidine reduces the production of aqueous humor and increases uveoscleral outflow, which helps manage intraocular pressure and is being explored for its potential benefits in Presbyopia. Carbachol stimulates muscarinic receptors to contract the ciliary muscle, improving near vision by enhancing the eye's ability to focus on close objects. These mechanisms are important for Presbyopia patients as they offer potential improvements in near vision, thereby enhancing daily activities and quality of life.

What side effects are associated with this type of intervention?

Common treatments for presbyopia, such as those involving Brimonidine and Carbachol, can have several side effects. Brimonidine may cause dry mouth, fatigue, headache, and ocular hyperemia. Carbachol can lead to headache, brow ache, and visual disturbances. Both medications may also cause local irritation and allergic reactions in some patients.

What prior FDA approvals exist?

There is limited information on prior FDA approvals specifically for presbyopia treatments that combine mechanisms similar to BRIMOCHOL™ PF. However, treatments involving muscarinic receptor stimulation, such as Carbachol, have been explored for their potential to improve near vision by contracting the ciliary muscle. Additionally, Brimonidine, known for reducing intraocular pressure, is primarily used in glaucoma management but its combination with Carbachol in presbyopia treatment is under investigation. Overall, the approach of using these pharmacological agents together for presbyopia is innovative and currently being studied.

What other types of research exist?

Promising novel alternatives to BRIMOCHOL™ PF for presbyopia treatment in 2024 include: 1) Pilocarpine eye drops, which improve near vision by inducing miosis and increasing depth of focus. 2) VUITY™ (pilocarpine HCl ophthalmic solution), recently approved for presbyopia, which enhances near vision by constricting the pupil. 3) PresbyLASIK, a laser eye surgery that reshapes the cornea to improve near vision. 4) Multifocal and extended depth of focus intraocular lenses (IOLs) for patients undergoing cataract surgery, which provide a range of vision from near to far. 5) Corneal inlays, small devices implanted in the cornea to improve near vision by increasing depth of focus.

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Cholinergic Agonist

BRIMOCHOL + Carbachol for Presbyopia

Phase 3

Waitlist Available

Research Sponsored by Visus Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have presbyopia

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline day 1

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

Summary

This trial tests eye drops called BRIMOCHOL™ PF and Carbachol PF. It targets people who have trouble seeing things up close due to aging. The drops aim to improve their close-up vision by working on the eye's muscles or structures.

Who is the study for?

This trial is for men and women in good health who have presbyopia, a condition that affects near vision typically in middle age. It's open to those with natural lens (phakic) or artificial lens implants (pseudophakic). People can't join if they have other medical conditions that could interfere with the study or are allergic to the drugs being tested.

What is being tested?

The study is testing BRIMOCHOL™ PF and Carbachol PF eye drops against a placebo (vehicle) to see which is better at improving near vision in people with presbyopia. Participants will be randomly assigned to receive one of these treatments.

What are the potential side effects?

Possible side effects from BRIMOCHOL™ PF and Carbachol PF may include temporary burning sensation in the eyes, headache, blurred vision, eye irritation or redness. The severity of side effects may vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need reading glasses due to age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in near VA

Side effects data

From 2023 Phase 3 trial • 182 Patients • NCT05270863

14%

Eye Irritation

Headache

Nephrolithiasis

100%

80%

60%

40%

20%

Study treatment Arm

BRIMOCHOL™ PF

Brimonidine Tartrate

Carbachol PF

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: BRIMOCHOL™ PFExperimental Treatment1 Intervention

A single drop in each eye at a visit.

Group II: Carbachol PFActive Control1 Intervention

A single drop in each eye at a visit.

Group III: VehiclePlacebo Group1 Intervention

A single drop in each eye at a visit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brimonidine

FDA approved

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Presbyopia, such as Brimonidine and Carbachol, work through distinct mechanisms. Brimonidine reduces the production of aqueous humor and increases uveoscleral outflow, which helps manage intraocular pressure and is being explored for its potential benefits in Presbyopia. Carbachol stimulates muscarinic receptors to contract the ciliary muscle, improving near vision by enhancing the eye's ability to focus on close objects. These mechanisms are important for Presbyopia patients as they offer potential improvements in near vision, thereby enhancing daily activities and quality of life.

Effects of prostaglandin E2 and cholinergic drugs on intraocular pressure.The M4 muscarinic antagonist MT-3 inhibits myopia in chick: evidence for site of action.