By William Elliott, MD, FACP, and James Chan, PharmD, PhD

Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.
Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.

The FDA has approved eye drops to treat presbyopia, commonly known as age-related blurry near vision. Presbyopia is a progressive condition that affects adults older than age 40 years. The solution includes pilocarpine, a cholinergic muscarinic receptor agonist used to treat glaucoma (miotic). Pilocarpine ophthalmic solution 1.25% is distributed as Vuity.

INDICATION

Pilocarpine ophthalmic solution (OS) can be prescribed to treat presbyopia.1

DOSAGE

The recommended dosage is one drop in each eye once daily.1 Pilocarpine OS is a 1.25% solution available as a 2.5 mL fill in 5 mL bottles.

POTENTIAL ADVANTAGES

Pilocarpine OS onsets rapidly (approximately 15 minutes) and lasts about six hours. It does not affect distance vision.1 Allergan uses a proprietary pHast technology that allows the drops to rapidly adjust to the physiologic pH of the tear film.2

POTENTIAL DISADVANTAGES

Pilocarpine causes reduced illumination and may cause accommodation spasm.1 The drug appears to be “fully” effective in about 25% to 30% of test subjects.1 Exercise caution when night driving and during other hazardous occupations in poor illumination. Rare cases of retinal detachment have been reported with other miotics.1 The most common (more than 5%) adverse reactions were headache and conjunctiva hyperemia. Less common reactions (1% to 5%) were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation.1

COMMENTS

Pilocarpine adjusts the pupil by contracting the iris sphincter muscle.1 This improves near and intermediate visual acuity while maintaining some pupillary response to light. Its efficacy was evaluated in two 30-day, randomized, double-masked, vehicle-controlled studies in subjects with presbyopia. Subjects ranged from age 40 to 55 years, with 375 randomized to pilocarpine OS and 375 randomized to the vehicle. The primary efficacy endpoint was the proportion of subjects gaining three lines or more in mesopic high contrast, binocular distance-corrected near visual acuity without losing more than one line (five letters) of corrected distance visual acuity at day 30, three hours after administration. A statistically significant proportion of participants achieved the efficacy endpoint vs. those on the vehicle (31% in study 1 and 26% in study 2 vs. 8% and 11%, respectively, for the vehicle).

CLINICAL IMPLICATIONS

Presbyopia is a highly prevalent refractive condition that results in loss of accommodation and visual ability to focus on objects at different distances associated with aging. It is estimated to affect 128 million Americans, or nearly half the U.S. adult population.2 Current treatment options for presbyopia correction include reading glasses; bifocal, trifocal, or progressive glasses; contact lens, and surgical correction.3 The pharmacologic approach involves miotics, which increase the depth of field by exerting a pinhole effect, such as carbachol and pilocarpine.3 Pilocarpine OS may be useful for certain settings where reading glasses may not be convenient. The cost of pilocarpine OS is $73.49 per 2.5 mL.

REFERENCES

  1. Allergan. Vuity prescribing information. October 2021.
  2. AbbVie. U.S. Food and Drug Administration approves VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%. Oct. 29, 2021.
  3. Grzybowski A, Markeviciute A, Zemaitiene R. A review of pharmacological presbyopia treatment. Asia Pac J Ophthalmol (Phila) 2020;9:226-233.