ESCRS Data: Twice-Daily Eye Drops Offer Non-Surgical Option for Presbyopia, 2-Year Study Shows
Specially formulated eye drops combining pilocarpine and diclofenac may provide a safe, effective, and well-tolerated alternative to reading glasses or surgery for presbyopia, according to new research presented at the 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS).1
“We conducted this research due to 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. 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," said Giovanna Benozzi, MD, director of the Center for Advanced Research for Presbyopia, in Buenos Aires, Argentina, who presented the data at ESCRS." We sought to provide robust clinical evidence supporting an innovative pharmacological solution to offer patients a non-invasive, convenient and effective alternative.”
In a retrospective study of 766 adults (373 women and 393 men, average age 55), patients instilled the drops two times daily, with an optional third dose for breakthrough symptoms. Each formulation contained a fixed dose of diclofenac but varied pilocarpine concentrations of 1%, 2%, or 3%.
Rapid, Sustained Improvement: One hour after the first dose, patients improved an average of 3.45 Jaeger lines in uncorrected near visual acuity, an effect sustained for a median of 434 days and followed for up to two years.
Dose-Response Results:
1% group (148 patients): 99% read at least two extra lines.
2% group (248 patients): 69% read three or more extra lines.
3% group (370 patients): 84% read three or more extra lines.
Long-Term Maintenance: Approximately 83% of all patients maintained good functional near vision at 12 months.
Safety Profile
Adverse effects were mild and transient:
Temporary dim vision (32%)
Mild instillation irritation (3.7%)
Headache (3.8%)
No serious adverse events, including increased intraocular pressure or retinal detachment, were reported during the 2-year follow-up. Dr. Benozzi noted that optimal pilocarpine concentration could be individualized based on baseline presbyopia severity.
“While these findings are encouraging, the single-center, retrospective design limits generalizability," said Professor Burkhard Dick, ESCRS President-Elect and Chair of Ophthalmology at University Eye Hospital Bochum. "Long-term pilocarpine use can occasionally cause night-vision difficulties or rare retinal complications, and chronic topical NSAID use may carry corneal risk. Broader, prospective, multi-centre trials are needed before widespread adoption.”
Dr. Benozzi emphasized that the treatment is not intended to replace surgery, but to serve as “a valuable solution for patients who need safe, effective, and personalised alternatives and seek freedom from the inconvenience of eyewear.”
Reference
[1] 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 14 September, https://pag.virtual-meeting.org/escrs/escrs2025/en-GB/pag/presentation/570375