2025: A Year of Presbyopia Promise

HOT TOPIC

Opus Genetics’ Presbyopia Drop Meets Primary Endpoint in Phase 3 Trial

Opus Genetics announced that its presbyopia drop met the primary endpoint in the VEGA-3 phase 3 trial. The trial, its second pivotal phase 3 trial, was designed to evaluate its phentolamine ophthalmic solution 0.75% for the treatment of presbyopia.

The trial met its primary endpoint, with a statistically significant 27.2% of participants treated with phentolamine ophthalmic solution 0.75% achieving a ≥ 15-letter improvement in binocular distance corrected near visual acuity with < 5-letter loss in binocular best-corrected distance visual acuity at 12 hours post-dose on day 8, as compared with only 11.5% of placebo achieving the same result.

According to the company’s CEO, George Magrath, MD, “The results of the VEGA-3 trial reinforce our belief that phentolamine ophthalmic solution 0.75% could offer an option to improve near vision for millions of adults affected by presbyopia.”

The company plans to file an application with the FDA in the second half of 2025.

My Two Cents

The presbyopia drops are coming! The presbyopia drops are coming! Just a few weeks ago, the FDA accepted Tenpoint Therapeutics’ new drug application for Brimochol PF for the treatment of presbyopia and has set a Prescription Drug User Fee Act date of January 28, 2026. Not to mention the availability of pilocarpine HCl ophthalmic solution 0.4% (Qlosi, Orasis Pharmaceuticals), which I’ve had quite a bit of success with so far, and Lenz Therapeutics’ LNZ100 is expected to receive FDA approval in the coming weeks. Whether you want to hear about presbyopia drops or not, you’re going to be inundated with them! You might as well read up on them because they can benefit patients who may not typically visit our practices. I am referring to those patients who “just want some cheap readers.” If we, as a profession, can get these patients in for comprehensive eye exams and educate them on the opportunities outside of readers, it would be a win for all involved.

OUTSIDE THE LANE

Instant Coffee Consumption a Potential Risk Factor for Dry AMD

A recent study published in Food Science & Nutrition identified a genetic link between instant coffee consumption and an increased risk of dry age-related macular degeneration (AMD).

The study analyzed coffee consumption data from more than 500,000 participants in the United Kingdom Biobank and AMD data from the FinnGen genome-wide association studies dataset for adults aged 50 and older. Using linkage disequilibrium score regression and Mendelian randomization, the study researchers found a significant genetic correlation between instant coffee intake and dry AMD risk, with a 6.92-fold increased risk associated with each standard deviation increase in consumption. No such association was observed for ground or decaffeinated coffee or for wet AMD.

The researchers suggested compounds unique to instant coffee, such as acrylamide and oxidized lipids, may contribute to retinal damage, potentially exacerbating AMD in genetically predisposed individuals. This finding contrasts with prior cohort studies suggesting coffee has protective effects against AMD, and highlights the need for advanced genetic methodologies to address confounding factors. The study’s implications for eye care providers include advising patients, particularly those with a genetic or familial predisposition to AMD, to reduce their consumption of instant coffee as a preventive measure. While the study provides robust genetic evidence, its limitations include a focus on European populations and a lack of detailed classification of coffee types.

Future research is needed to validate these findings in diverse populations and investigate the metabolic pathways linking instant coffee to the pathophysiology of AMD. As eye doctors, we should consider integrating these insights into personalized prevention strategies, recommending alternatives to brewed or ground coffee, and emphasizing the importance of regular eye exams for patients at risk. This study emphasizes the significance of dietary counseling in managing AMD. (Read more here.)

My Two Cents

I am a coffee fanatic. I love the stuff. A few weeks ago, when I was lecturing with Paul Karpecki, OD, FAAO, and Jaclyn Garlich, OD, FAAO, in Chicago, one of the highlights of the trip was a visit to the three-story Starbucks Reserve Roastery on Michigan Avenue. It was coffee nirvana. That said, as much as I love coffee, I’ve never had instant coffee! The stuff never really excited me, and after reading this study, I’m glad I haven’t. The article and the study are fantastic; however, I haven’t been able determine why instant coffee appears to cause a significant increase in the risk of AMD. The study does point out compounds such as acrylamide and oxidized lipids, which are much more common in instant coffee due to its processing methods. Nevertheless, this requires further study to confirm the higher risk, and we could then easily incorporate a warning into our daily recommendations for patients. Again, it is worth noting that the only type of coffee that appears to increase the risk of AMD is instant coffee. Other types seemingly have no effect!

CAN YOU RELATE

Last week, a small gathering of doctors at our practice came together for the first of three meetings to streamline some basic procedures for our staff. We discussed things such as which tests should be performed for patients with glaucoma, what should be done for flashes and floaters, and whether patients should be dilated before trialing multifocal contact lenses, etc. Although it's pretty basic in a practice as large and established as Williamson Eye Center, every doctor has their own slightly different protocols.

This simple meeting with the administration was a brilliant idea by our CEO, Charles H. Williamson Jr, and our COO, Megan Roberts. It brought optometrists who are on the frontline of our clinics' primary care together to try to figure out some semblance of what should happen during different types of visits and workups. I’m not sure if anything like this has ever happened in the history of our company, and to be honest, it’s something that should occur regularly in every clinic that has at least two providers.

Technology is constantly changing, and so are the protocols related to the treatment and management of various ocular diseases. By getting together with your team and ensuring everyone is on the same page, everyone benefits—from the doctors to the staff and the patients. We should keep in mind that the American Optometric Association and the American Academy of Ophthalmology have extensively researched and meticulously developed preferred practice patterns for nearly everything related to the eye, so let’s not forget about these valuable resources.

My recommendation for you this week is to look at your workup protocols for your various exams. Ensure your staff is aware of the specific types of testing required for each and, arguably more importantly, understands the rationale behind these tests. We take visual fields for granted for our patients with glaucoma, but do our staff honestly know why we run them? What about the different types of defects and other things that a visual fields test can detect? Don’t forget about why we may run a macular OCT on a diabetic patient with hemorrhages! The list goes on and on. Our staff wants to be engaged. They want to learn. They want their jobs to fulfill them, and what’s more fulfilling than helping someone see their best to live their best?

QUOTE OF THE WEEK

“Pleasure in the job puts perfection in the work.”

— Aristotle