BRIMOCHOL PF is a fixed-dose combination eye drop in development for presbyopia. It showed a significant improvement in patients' near vision for up to 8 hours in its phase 3 trial.
Do you struggle with reading up-close? Are you looking for ways to improve your vision and reduce the need for reading glasses? If so, you may be interested in learning about treatments for presbyopia, a common condition that affects millions worldwide. Luckily, there are several options available, including glasses, contact lenses, eye drops, and surgical procedures.
Even more excitingly, a new eye drop called BRIMOCHOL PF has recently announced positive results from its Phase 3 clinical trial, showing great potential for effective treatment if approved by the FDA in the future. Keep reading to learn more about BRIMOCHOL PF and other treatments for presbyopia.
Understanding presbyopia
As we age, our eyes undergo a natural process that includes changes in the lens, making it more rigid. This rigidity can make it difficult for the eye to focus on nearby objects, resulting in presbyopia, also known as age-related farsightedness.
Presbyopia is the most common cause of vision impairment and affects a significant number of people worldwide. Typically, adults begin to experience a loss of near vision in their mid-40s, and the condition is nearly universal by age 50. 1
The World Report on Vision published by the World Health Organization in 2019 estimated that globally, there were 1.8 billion people with presbyopia*. In North America (including the US and Canada), 113 million people were affected, with a prevalence of 32%. In Western Europe, 165 million people were affected, with a prevalence of 39%. In East Asia, the number of people with presbyopia was the highest, with 437 million individuals affected and a prevalence of 30%. And the number of people affected by presbyopia is expected to increase to approximately 2.1 billion by 2030 due to population growth.1
Fortunately, presbyopia can be managed with various nonsurgical and surgical approaches, including eyeglasses, contact lenses, eye drops, and surgical treatments. Eyeglasses are the most common way to address vision issues caused by presbyopia. Contact lenses are another option, but may not be suitable for people undergoing eye injections or who had eye surgery due to the increased likelihood of having dry eye.
In 2021, the FDA approved the first pharmaceutical treatment for presbyopia called Vuity (pilocarpine 1.25% ophthalmic solution). This eye drop is a miotic, which narrows the pupil of the eye (the black part of your eye). It acts on and contracts the ciliary muscle. The contraction helps the lens of the eye change shape, creating a pinhole effect and allowing for better focus on nearby objects. The eye drop was found to be effective in improving close-up vision within 15 minutes of use, with the effects lasting for 6 hours or longer. The most commonly reported side effects were mild headaches and eye redness, with some people also reporting blurred vision, eye pain, eye irritation, and tearing.
Surgical procedures for presbyopia are usually considered when other treatments such as glasses, contact lenses, or medications are no longer effective or suitable for the patient. They include keratorefractive surgery, corneal inlay, phakic intraocular lens implantation (PILI), and refractive lens exchange (RLE).
What is BRIMOCHOL PF?
Since the launch of Vuity, the use of eye drops to treat presbyopia has gained significant traction. Excitingly, Visus Therapeutics has recently announced positive results from a Phase 3 pivotal trial of BRIMOCHOL PF™ for the treatment of presbyopia, providing a preservative-free solution that has a longer duration of action for people living with this condition.2
The company has highlighted that BRIMOCHOL PF successfully demonstrated "contribution-of-elements" in their press release, explaining that it contains two different medicines, carbachol and brimonidine tartrate, that can work hand in hand to provide a more effective solution that may have reduced side effects.
Carbachol is a miotic that constricts the pupil, making it smaller, while brimonidine tartrate prevents pupil dilation. Brimonidine tartrate also helps reduce side effects that can occur by stopping the ciliary muscle from contracting too much -- a side effect common to miotics.
BRIMOCHOL PF was tested in a Phase 3 clinical trial in both the US and EU/UK, which showed that it worked better than carbachol or brimonidine individually.2
The results from the trial also showed that people who used BRIMOCHOL PF had a significant improvement in their near vision for up to 8 hours, and their pupils remained smaller for up to 10 hours. Moreover, the medication was well-tolerated, with no treatment-related serious adverse events reported.2
Further information on BRIMOCHOL PF will be presented at upcoming medical meetings in May, so stay tuned for more details.
Key takeaways
In sum, presbyopia is a common condition that most people will likely encounter, including you and me. Fortunately, there are many different treatments available to manage this condition, including glasses, contact lenses, medications, and surgical procedures. With promising results of BRIMOCHOL PF in its Phase 3 trial, we may have even more options to effectively treat presbyopia in the future.
As technology continues to advance, we can look forward to further developments and improvements in the treatment of this condition. So if you're struggling with reading up-close and may need more than reading glasses, talk to your eye care provider about what may be appropriate for you.
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*1.8 billion, including both addressed and unaddressed presbyopia, (confidence interval [CI], 1.7–2.0) people of all ages with presbyopia in 2015.
1. World Health Organization. (2019). World report on vision. Geneva: World Health Organization.
2. Abdelkader, Almamoun, and Herbert E Kaufman. “Clinical outcomes of combined versus separate carbachol and brimonidine drops in correcting presbyopia.” Eye and vision (London, England) vol. 3 31. 5 Dec. 2016.
3.Visus Therapeutics. (2023, April 20). Visus Therapeutics Announces Positive Topline Clinical Data from Phase 3 Pivotal BRIO-I Trial of BRIMOCHOL PF™ for the Treatment of Presbyopia [Press release]. Retrieved from https://uploads-ssl.webflow.com/61088b48cbb6c4347abaaca5/6440bfed69d8c4bc51bfdd71_Visus%20Announces%20Positive%20Topline%20Clinical%20Data_PR_19April2023_500pm%20FINAL.pdf
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