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Treatment of presbyopia using pilocarpine and aceclidine

Published : Friday, 18 April, 2025 at 12:00 AM  Count : 468
Dr Mohammad Mizanur Rahman
After age 40, most healthy people need reading glasses because of a condition called presbyopia. Presbyopia, an age-related refractive issue, affects almost all people over the age of 40 in some form. Defined as the gradual loss of the eye's ability to focus on near objects, it results from a decrease in the elasticity of the crystalline lens and decreased performance of the ciliary muscles.

Historically, presbyopia has been addressed with corrective lenses, ?bifocals, progressive addition lenses, contact lenses or surgical approaches. It is, however, the recent pharmacological approach, particularly with the miotic agents such as pilocarpine and aceclidine, that represents a landmark progress in the treatment and management of this impairment to near vision.

In the global context, more than 1.8 billion people are estimated to have presbyopia. A lot of these people reside in countries with low and middle incomes where it's hard to get corrective eyewear. This means a solution using drops that doesn't require surgery could shake things up in rural areas and communities that don't have enough resources. People often prefer treatments using drugs. This is true for those who don't want to wear glasses or are looking for options that are less invasive than going under the knife.

Pilocarpine is a parasympathomimetic alkaloid that acts on muscarinic receptors to constrict the pupil (miosis) and cause ciliary muscle contraction. This extends the depth of focus and enhances near vision.
Aceclidine is a muscarinic agonist, yet it has lower systemic side effects and a more selective action. It causes miosis with minimal effect on accommodation and has shown promise as a treatment for presbyopia.

In 2021, the U.S. Food and Drug Administration (FDA) approved Vuity™, the first prescription eye drop to treat presbyopia. The active ingredient in Vuity is 1.25% pilocarpine hydrochloride. Developed by AbbVie's Allergan, Vuity works within 15 minutes of administration and provides improvement in near vision for up to 6 hours.

A pivotal Phase 3 clinical study named GEMINI 1 and GEMINI 2 involved over 750 participants aged 40-55 years. According to the findings, 31% of individuals gained three lines or more of near visual acuity without losing distance vision. The drop was well tolerated, with headaches and eye redness being the most common side effects.

In Europe, aceclidine has been studied as a novel treatment for presbyopia due to its favourable safety profile. A notable study conducted by Harmann in Germany compared aceclidine with pilocarpine and found that aceclidine produced less ciliary spasm and fewer complaints of brow ache and visual distortion.

Additionally, researchers in Spain and France have evaluated aceclidine-based combinations with low-dose anti-inflammatory agents to reduce side effects. The pharmacological profile of aceclidine makes it suitable for combination therapy, minimizing rebound pupil dilation and improving patient comfort.

In India, where the burden of uncorrected presbyopia is significant due to limited access to optical correction in rural areas, clinical trials have shown promising results using pilocarpine-based eye drops. The All India Institute of Medical Sciences (AIIMS) in Delhi has been exploring cost-effective pilocarpine formulations to serve the rural population. These locally manufactured drops, if approved, could drastically reduce dependency on spectacles and improve productivity among aging workers in agriculture and cottage industries.

In East Asia, particularly Japan and South Korea, researchers have been testing combinations of pilocarpine and aceclidine with non-steroidal anti-inflammatory drugs (NSAIDs) to reduce inflammation and prolong the therapeutic effect. These studies focus on improving patient compliance, especially among older adults with multiple eye conditions like dry eye disease and glaucoma.

One such study conducted at the University of Tokyo in 2022 showed that combining aceclidine with ketorolac resulted in better tolerability and a longer duration of action compared to monotherapy.

Pilocarpine and aceclidine both cause miosis, decreasing the size of the pupil and consequently augmenting the depth of focus based on the pinhole effect. This helps the eye focus properly on items located close to it without requiring flexibility of the lens. A minor change in the lens form due to the contraction of ciliary muscles can, in addition, enhance accommodation in the beginning presbyopia.

But long-time intake might cause pupil exhaustion, accommodative spasm or long-term inflammation if proved unregulated. To reduce side effects studies are still being conducted to determine the ideal concentration and frequency of administration.

Advantages over Conventional Options Non-invasive: Unlike surgical options such as corneal inlays or lens replacement, these drops are easy to administer. If the patient experiences discomfort or inefficacy, the treatment can be stopped without permanent changes. Affordable: With mass production and generic options, pharmacological drops can become more cost-effective than multifocal glasses.

Limitations and Challenges While the initial results are promising, the treatment isn't without drawbacks. The drops typically work for 4-6 hours, requiring repeated dosing. Side Effects Headaches, dim vision in low light due to miosis, and eye irritation are common. Patient Selection: These drops may not be suitable for individuals with existing ocular inflammation, history of retinal detachment, or narrow-angle glaucoma.

The development of dual-mechanism drugs combining miosis with anti-inflammatory or neuroprotective agents is currently underway. Artificial intelligence (AI)-driven personalization of treatment schedules and drop combinations may also emerge soon.

Further research is exploring sustained-release ocular inserts and nanoparticle delivery systems, which could offer a once-weekly or even monthly solution for presbyopia.

The use of pilocarpine and aceclidine for presbyopia represents a revolutionary step in non-surgical vision care. While not a panacea, these drops offer a viable alternative for millions seeking independence from reading glasses. With ongoing studies across the USA, Europe, Asia, and other regions, pharmacological management is poised to become a mainstream option for presbyopia in the next decade.

The writer is Ph.D. (Optometry), Research Fellow & Assistant Professor, Management & Science University (MSU), Malaysia


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