Presbyopia

The company said the submission marks its sixth regulatory filing outside the US following FDA approval in July 2025.

Data from a recent trial of the OmniVu Lens System was presented at ASCRS 2026, featuring positive and sustained vision end points.

The formulation combines 2 pharmacologic agents: carbachol, a direct-acting cholinergic agonist, and brimonidine tartrate, an α-2 adrenergic receptor agonist.

The clinical study will evaluate a noninvasive corneal strengthening procedure designed to reshape the cornea and correct refractive errors in-office without tissue removal.

The FDA has assigned a PDUFA goal date of October 17, 2026.

Derek N. Cunningham, OD, FAAO, details candidate selection, mechanism of action, and patient education for the new eye drop.

Formerly known as Brimochol PF, the dual-agent eye drop is now the first and only of its kind for the treatment of presbyopia in adults.

Lens thickness and ciliary muscle are not affected by low-dose pilocarpine.

Previously, the EDOF technology was specifically limited to intraocular lenses.

Understanding the different expectations between patients with these conditions is key to choosing the appropriate refractive surgery.

Most active ingredients in presbyopia-correcting eye drops, including pilocarpine, aceclidine, and carbachol, are direct-acting cholinergic agonists that activate the iris sphincter muscle, causing pupil constriction.

This is the first submission for approval under the exclusive license and commercialization agreement for South Korea that was signed between LENZ and Lotus.

Advances address a need for the growing populace with age-related near vision loss.

The submission marks the first ex-US regulatory submission for Brimochol PF.

Commercial product shipments will be initiated for patients in October through LENZ’s ePharmacy partner, and the product is anticipated to be available in commercial locations such as retail pharmacies by the middle of the fourth quarter of this year.

The lens will be available to order on September 17 in the US.

The trial will evaluate the solution in treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision.

The latest in drug and technology developments and updates from July 2025.

Vizz (LENZ Therapeutics) is the first and only aceclidine-based eye drop for presbyopia and is also the first daily solution to correct vision for up to 10 hours.

Beginning in July 21, the Varilux Physio extensee and Varilux Physio extensee Classic Edition will be available in the US.

The Innovation Hub was split into 3 panel discussions on assessing future health through AI-enabled tools, addressing patient workflow challenges through AI, and enhancing treatment through new technologies.

The PDUFA date for Brimochol PF is January 28, 2026.

While the study included a range of patients in a variety of stages of presbyopia, the change in crystalline lens and anterior segment geometry was most pronounced in emmetropic and myopic presbyopes.

Brimochol PF’s combination of brimonidine and carbachol produces a “pinhole effect,” which is intended to improve depth of focus and sharpen near and distant impact.

The lens has been introduced to select practices across the US, with broad commercial availability planned for in May.