For those grappling with presbyopia, a common age-related condition that blurs near vision and often necessitates reading glasses, a new solution may be on the horizon: specially formulated eye drops. These drops could offer a simple way to improve focus on close-up objects.

A recent retrospective study involving 766 patients, presented at the 43^rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), revealed that a significant number of participants experienced improved near visual acuity after using these eye drops. According to the study, many patients were able to read an additional two, three, or even more lines on the Jaeger chart, a standard tool for assessing near vision.The benefits reportedly lasted for as long as two years.

According to Dr. Giovanna Benozzi, director of the Center for Advanced Research for Presbyopia in Buenos aires, Argentina, the research addresses “the significant unmet medical need in presbyopia management.” “Current solutions such as reading glasses or surgical interventions have limitations, including inconvenience, social discomfort, and potential risks or complications,” she stated. “There is a group of presbyopia patients who have limited options besides spectacles, and who are not candidates for surgery; these are our primary focus of interest. We sought to provide robust clinical evidence supporting an innovative pharmacological solution to offer patients a non-invasive, convenient and effective option.”

The eye drops in question, developed by Dr. Benozzi’s father, the late Dr. Jorge Benozzi, combine pilocarpine and diclofenac.Pilocarpine constricts the pupils and contracts the ciliary muscle, aiding the eye’s ability to focus at different distances. Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), helps to mitigate inflammation and discomfort often associated with pilocarpine use.

Participants in the study used the eye drops twice daily, typically upon waking and again six hours later, with an optional third dose as needed. The patient group, comprising 373 women and 393 men with an average age of 55, was divided into three subgroups, each receiving a different formulation of the eye drops. While each formulation contained a fixed dose of diclofenac, the pilocarpine concentrations varied at 1%, 2%, and 3%.

Researchers evaluated the betterment in uncorrected near visual acuity (how well patients could read the jaeger chart without glasses) one hour after the initial administration of the drops and continued to monitor the patients over a two-year period.

“Our most significant result showed rapid and sustained improvements in near vision for all three concentrations. One hour after having the first drops, patients had an average improvement of 3.45 Jaeger lines.”

Dr. Benozzi told the Congress: “Our most significant result showed rapid and sustained improvements in near vision for all three concentrations. One hour after having the first drops,patients had an average improvement of 3.45 Jaeger lines. The treatment also improved focus at all distances.”

“Impressively, 99% of 148 patients in the 1% pilocarpine group reached optimal near vision and were able to read two or more extra lines. Approximately 83% of all patients maintained good functional near vision at 12 months. Importantly, no significant adverse events like increased intraocular pressure or retinal detachment were observed.”

The study also found that in the 2% group, 69% of 248 patients could read three or more additional lines on the Jaeger chart, while in the 3% group, 84% of 370 patients achieved the same result.

The improvements in vision were sustained for a median duration of 434 days. mild side effects were reported, including temporary dim vision (32% of cases), irritation upon instillation (3.7%), and headache (3.8%). No patients discontinued the treatment due to these side effects.

It’s worth noting that common side effects associated with pilocarpine can include eye redness, watery eyes, blurred vision, dim or dark vision, sensitivity to light, difficulty changing focus, seeing flashes of light or floaters, and, in rare instances, retinal detachment.

Dr. Benozzi added, “Nearly all patients experienced positive improvements in near visual acuity, even though the magnitude of the improvement depended on the status of their vision before treatment at baseline. Our study revealed that optimal pilocarpine concentrations could be individualized depending on the baseline severity of presbyopia as assessed by the initial Jaeger scores. Patients with less severe presbyopia responded best to 1% concentrations, while those with more advanced presbyopia required higher 2% or 3% concentrations to achieve significant visual improvement.”

She concluded: “These results suggest this combination therapy offers a safe,effective,and well-tolerated alternative to conventional presbyopia management. It substantially reduces dependence on reading glasses, providing a convenient, non-invasive option for patients, although these eye drops may not eliminate the need for glasses in all individuals.”

“Importantly, this treatment is not intended to replace surgical interventions, but rather to serve as a valuable solution for patients who need safe, effective, and personalised alternatives and seek freedom from the inconvenience of eyewear. Eye care professionals now have an evidence-based pharmacological option that expands the spectrum of presbyopia care beyond glasses and surgery.”

Beyond the study group, Dr. Benozzi has observed positive outcomes in patients using the treatment for over a decade. Future research will focus on measuring improvements in patients’ quality of life and exploring the physiological mechanisms of the eye drops.

The study’s strengths include the large patient sample size and extended follow-up period. It also marks the first systematic evaluation comparing three different pilocarpine concentrations in combination with diclofenac. However, the retrospective, single-center design may limit the generalizability of the findings and introduce selection bias.

Professor Burkhard Dick, ESCRS President-Elect and chair of ophthalmology at the University Eye Hospital Bochum, Germany, who was not involved in the research, commented: “While surgery for age-related near vision loss has advanced, some patients are not candidates. The single-center retrospective study by Dr Benozzi suggests that eye drops containing pilocarpine and diclofenac may improve near vision for up to two years, but the limited design means the results may not apply to everyone. Long-term pilocarpine use can sometimes cause side effects such as reduced night vision, dimmer vision in low light, eye strain, irritation and, in rare cases, retinal detachment, while prolonged topical NSAID use may pose corneal risks. Broader,long-term,multi-centre studies are needed to confirm safety and effectiveness before this treatment can be widely recommended.”