- Researchers estimate that about 1.8 billion people around the world live with presbyopia, a farsightedness condition that can appear as a person grows older.
- More recent treatment options for presbyopia are eye drops such as Vuity, which uses pilocarpine hydrochloride.
- A new study found that a new eye drop using both pilocarpine plus diclofenac helped study participants improve their ability to read up close.
Researchers estimate that about
Current treatments for presbyopia include reading glasses, glasses with bifocal or multifocal lenses, bifocal contact lenses, or surgery, such as LASIK.
More recent treatment options for presbyopia are eye drops such as Vuity, which were approved for use by the Food and Drug Administration (FDA) in October 2021. Vuity contains pilocarpine hydrochloride, which is also used to treat dry mouth and glaucoma.
Now, a new study presented at the 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) reports that a new eye drop formula using both pilocarpine and a nonsteroidal anti-inflammatory drug (NSAID) called diclofenac helped participants improve their ability to read a
The findings are yet to appear in a peer-reviewed journal.
For this study, researchers recruited 766 participants diagnosed with presbyopia. Participants were treated with the pilocarpine-diclofenac eye drops at three different percentages of pilocarpine — 1%, 2%, or 3% — twice a day.
“The eye drop we studied is based on a pharmacological method that uses a combination of drugs that together act in a beneficial way to focus,” Giovanna Benozzi, MD, director of the Center for Advanced Research for Presbyopia in Argentina, and lead author of this study, explained to Medical News Today.
“In simple words, the drops help the eye ‘recover’ its natural ability to change focus from far to near, something that is gradually lost with age,” Benozzi said.
“This combined and personalized formulation (different concentrations) has a dual mechanism acting directly in the muscle responsible [for] focus (
At the study’s conclusion, researchers found that the majority of participants treated with the new eye drops could read an extra two, three, or more lines on the Jaeger eye chart.
“In ophthalmology, each line on the reading chart represents a meaningful improvement in real life,” Benozzi said. “Gaining two or three lines means a patient who previously struggled to read a text message or a menu can now do so with ease.”
“The study of the real world that we presented at the European Congress of Cataract and Refractive Surgery (ESCRS) in Copenhagen, demonstrates that all the patients treated (766) achieved J3 or better in near visual acuity, that means that all of the patients gain a functional near visual acuity.”
— Giovanna Benozzi, MD
“The other result was that the patients with mild and intermediate presbyopia, achieved a normal near vision (J1.J2) eliminating the need of near eyeglasses. It’s not just numbers on a chart — it’s restoring independence in daily activities like looking [at] the cell phone, reading a menu, the GPS, etc,” Benozzi noted.
Additionally, Benozzi and her team found that the vision effect from the eye drops lasted for up to 2 years, for a median of 434 days.
“This is highly significant because it shows the treatment is not a short-lived effect,” Benozzi explained.
“The results of this real-world study and other studies we made in the past, including a multicenter one, now reinforced by mechanistic insight, indicate that pilocarpine–diclofenac therapy is both effective and safe in the medium to long term. For a chronic, progressive condition like presbyopia, durability is essential.”
— Giovanna Benozzi, MD
“Pharmacological treatment for presbyopia with a personalized combination of these drugs is now a real, evidence-based option,” she continued. “With this formulation, patients can regain near vision safely and effectively, without the need for glasses for those patients that are not candidates yet [for] presbyopia surgery.”
“Even if we have thousands of patients (20,000) treated with long follow-up (15 years) with a compound formulation, some further research is needed to reinforce our data,” Benozzi added. “We hope to find a partner soon to internationalize this asset.”
MNT spoke with Benjamin Bert, MD, a board certified ophthalmologist at MemorialCare Orange Coast Medical Center in Fountain Valley, CA, about this study.
Bert, who was not involved in the research, commented that this study expanded on some of the treatments already being used for presbyopia, such as Vuity, which also uses pilocarpine.
“The difference with the drop that they used in this study is that they added a medication called diclofenac, which is a non-steroidal anti-inflammatory medication, to try to counteract some of the side effects that happen from pilocarpine, which includes pain, kind of like a pressure sensation, or even causing a headache,” he explained.
Bert said that considering the fact that if we all live long enough, every single person is going to experience the annoyances and challenges that occur with presbyopia, and so it’s a huge area where millions of people could be helped with an appropriate treatment.
“It would be really nice if the direct cause of presbyopia could be treated,” he continued. “And again, the thought process right now is not so much that our muscles get weak as we get older, but rather that the lens inside of the eye gets harder. And so it’s less malleable — the muscles aren’t able to change its shape as readily.”
“So it would be fantastic if research continued, and hopefully at some point in the future, we had an eye drop or a treatment that would be able to soften the lens back to the way that it is when we’re younger, so that our eyes would continue to function the way that we always remember them functioning,” Bert added.
MNT also spoke with David I. Geffen, OD, FAAO, director of optometric and refractive services at the Gordon Schanzlin New Vision in La Jolla, CA, about this research.
“Pilocarpine drops for the use in presbyopia have been approved in the U.S. for several years now and have had limited use in this market,” Geffen, who was not involved in the study, said.
However, he advised that: “Pilocarpine works on the ciliary muscle, causing some pulling on the eye, which causes questions for retina issues. Caution in using these drops especially in higher myopes must be done.”
“There are several drops which have come to the market and more to be approved in the U.S.,” he continued. “Aceclidine has just recently been approved, and this unique drop works only on the
“This drop appears in studies to be a safer alternative than pilocarpine. Studies show this drop is more effective with a longer acting time than the pilocarpine alternatives,” Geffen added.
“Because everyone [can develop] presbyopia, the unmet need for clarity and convenience is huge. It is important for us to develop better alternatives for our patients. Presbyopic drops are a good alternative to those patients who are unhappy with their reading glasses and can lead to more freedom for them. I would like to see more research in this area to make sure we are using safe drugs helping our patients live a better lifestyle.”
— David I. Geffen, OD, FAAO
