Once-Daily Eye Drop Brimochol Shows Positive Phase 2 Results for Presbyopia, Enabling Potential Freedom from Reading Glasses

On November 30, 2021, Visus Therapeutics announced positive results from a Phase 2 clinical trial evaluating the efficacy of its investigational innovative eye drop, Brimochol. The trial results showed that both formulations of Brimochol and the active control group achieved the primary endpoint of improving near vision in patients with presbyopia, without significant loss of distance vision. The response rate was over 83% one hour after treatment, with at least 35% of participants in all three groups reaching the same endpoint at 9 hours. Additionally, all three formulations were well-tolerated. Based on these positive results, the company plans to initiate pivotal Phase 3 clinical trials in the near future.

Presbyopia: A Common Age-Related Vision Decline Affecting Billions WorldwidePresbyopia is a common age-related vision decline that affects billions of people worldwide. As we age, the elasticity of the lens in our eyes deteriorates, and the contracting ability of the ciliary muscles, which control the shape of the lens, gradually decreases. These combined factors lead to a decline in the focusing ability of the lens, making it difficult for close images to focus on the retina. Presbyopia typically occurs after the age of 40, and currently, the most common treatment method is wearing reading glasses, which are inconvenient for many people.

Visus Therapeutics' investigational product Brimochol is an eye drop designed for once-daily administration to correct near vision loss associated with presbyopia. It combines two approved drugs, carbachol and brimonidine. The miotic agent carbachol may stimulate the contraction of the ciliary muscle, which controls the shape of the lens while reducing the size of the pupil. This changes the refractive characteristics of the lens and can lead to a reduction in distance vision. Patients undergoing regular treatment may also experience side effects such as headaches, myopic shift, and red eyes. Brimonidine, an α2-adrenergic receptor agonist, helps inhibit the contraction of the ciliary muscle and reduce eye redness. It also extends the half-life of carbachol, allowing its effects to last 8-12 hours, meaning that a single morning application could potentially provide all-day benefits.

This dose-finding, multi-center, three-arm crossover Phase 3 clinical trial enrolled 85 presbyopia patients aged between 45 and 80. In the trial, patients were randomly treated with two fixed doses of Brimochol and Brimochol F formulations, as well as a preservative-free carbachol F formulation.

Test results showed that in the three treatment groups, at least 83% of participants experienced an improvement of at least three lines in the DCNVA (near vision) metric within one hour of treatment, with a reduction of fewer than one line in distance vision metrics. In the three groups, at least 82%, 52%, and 35% of participants reached the same endpoint at 3, 7, and 9 hours, respectively. In terms of safety, Brimochol, Brimochol F, and Carbachol F were all well-tolerated, with no unexpected adverse events reported. Adverse events occurring in more than 5% of participants included temporary burning and stinging upon instillation, headache, and brow pain. No serious adverse events were reported.

References:

[1] Visus Therapeutics Announces Positive Topline Clinical Data from Phase 2 VIVID Study of Brimochol for the Treatment of Presbyopia. Retrieved November 30, 2021, from https://www.businesswire.com/news/home/20211130005414/en

(Original text has been abridged)

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