Presbyopia, a common condition where individuals experience difficulty focusing on near objects as they age, often necessitates the use of reading glasses. Recent research suggests that the solution may be as simple as administering specialized eye drops two to three times a day.
Study Overview
A retrospective study involving 766 patients was presented on September 14 at the 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS). The study found that most participants were able to read an additional two or more lines on the Jaeger chart, which is used for testing near visual acuity, after using the specially formulated eye drops. This improvement was maintained for up to two years.
Research Insights
Dr. Giovanna Benozzi, director of the Center for Advanced Research for Presbyopia in Buenos Aires, Argentina, stated, “Our research addresses the significant unmet medical need in managing presbyopia. Current solutions, such as reading glasses or surgical interventions, come with limitations, including inconvenience and potential risks. Our primary focus is to offer a robust clinical alternative to patients who have limited options.” The goal was to provide substantial evidence supporting an innovative pharmacological solution that is non-invasive and user-friendly.
Composition and Administration of Eye Drops
The eye drops, developed by Dr. Benozzi’s late father, Dr. Jorge Benozzi, contain two active ingredients: pilocarpine, which constricts the pupils and controls the ciliary muscle responsible for adjusting focus at various distances, and diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that mitigates inflammation and discomfort associated with pilocarpine.
Patients administered the eye drops twice daily, typically upon waking and approximately six hours later, with the option of a third dose if symptoms recurred. The study group consisted of 373 women and 393 men, averaging 55 years old, who were assigned to one of three formulations containing fixed diclofenac doses but varying concentrations of pilocarpine (1%, 2%, and 3%).
Results and Efficacy
The researchers evaluated improvements in participants’ near visual acuity one hour after the initial administration of the drops, followed by a two-year follow-up. Dr. Benozzi emphasized, “Our most significant finding was the rapid and sustained enhancement in near vision across all concentrations. One hour post-administration, patients exhibited an average improvement of 3.45 Jaeger lines.” The treatment also facilitated better focus across all distances.
Remarkably, 99% of patients in the 1% pilocarpine group reached optimal near vision, enabling them to read two or more additional lines. Approximately 83% maintained good functional near vision at the 12-month mark. Importantly, no severe adverse events, such as increased intraocular pressure or retinal detachment, were documented.
Patient Tolerance and Side Effects
In the 2% pilocarpine group, 69% and in the 3% group, 84% of patients could read three or more additional lines on the Jaeger chart. The vision improvements lasted up to two years, with a median duration of 434 days. Mild adverse effects were reported, including temporary dim vision (32%), irritation during instillation (3.7%), and headaches (3.8%). Importantly, no patients discontinued treatment.
Common side effects associated with pilocarpine may include eye redness, blurred vision, and light sensitivity. Rare effects can involve retinal detachment.
Conclusion
Dr. Benozzi concluded that the combination therapy presents a safe and well-tolerated alternative for presbyopia management, significantly reducing reliance on reading glasses. “While this treatment is not intended to replace surgical options, it offers a valuable non-invasive alternative for patients seeking greater freedom from eyewear,” she stated. The potential for personalized pilocarpine concentration adjustments based on baseline presbyopia severity was also highlighted.
Future Research and Considerations
While the study has notable strengths, including the large patient cohort and extended follow-up duration, it remains a retrospective and single-center investigation, which may limit the generalizability of findings. ESCRS President-Elect Professor Burkhard Dick emphasized the need for broader, long-term studies to confirm the safety and efficacy of these eye drops for a wider population.
Key Health Takeaway
The recent study suggests that specially formulated eye drops combining pilocarpine and diclofenac may significantly improve near vision for individuals with presbyopia, potentially offering a non-invasive alternative to traditional eyewear. While further research is needed to validate these findings, the results indicate a promising move towards personalized care in managing presbyopia.
Notes
- Abstract number: ESCRS25-FP-3944, ‘Dose-dependent efficacy and safety of pilocarpine-diclofenac eye drops for presbyopia: a real-world single-center study,” by Giovanna Benozzi et al. Free paper session on ‘Miscellaneous topics in cataract and refractive surgery’, 16:30-18:00 hrs CEST, Sunday, September 14, https://pag.virtual-meeting.org/escrs/escrs2025/en-GB/pag/presentation/570375
