Presbyopia treatment has recently changed with the FDA approval of Vuity from Allergan. This drop is indicated for the treatment of presbyopia in adults, with patients in the age range of 40-55 included in the pivotal clinical trials (GEMINI 1 and GEMINI 2).1 As we know, the risk of dry eye disease increases with age, especially from the fourth to eighth decades of life, which is also the age where presbyopia treatment becomes necessary.2 This fact begs the question: What is the potential effect on the ocular surface using a topical eye drop for presbyopia?
Vuity is an ophthalmic solution containing the active ingredient pilocarpine hydrochloride 1.25%. It comes in a 5.0 mL bottle and contains the preservative benzalkonium chloride 0.0075%. It is dosed once daily in both eyes for improved near vision.1
Pilocarpine is a medication with a long history of use in ophthalmology. A unique characteristic of Vuity is its formulation compared to previous pilocarpine eye drops. All pilocarpine formulations are stored at a low pH to maintain stability.3-5 This acidity causes stinging and increased tear fluid flow when instilled in the eye. To maximize bioavailability, the vehicle for pilocarpine has traditionally been highly viscous to extend time on the ocular surface.3-5 Vuity, however, is formulated with pHastTM technology that equilibrates the drop to physiologic pH within one minute of drop instillation.6 This change to the formulation provides improved tolerability and comfort of the drop. It also improves the ocular bioavailability of the medication, which allows for once daily dosing compared to the past need for more frequent dosing, potentially resulting in more ocular surface irritation.6 With the improved ocular bioavailability, the vehicle for Vuity is less viscous, minimizing visual blur and ocular surface disruption.
Given the improved formulation of Vuity as well as the once daily dosing schedule, anticipated effect on the ocular surface with this medication is minimal. Only 1-5% of patients in the GEMINI 1 and GEMINI 2 studies reported adverse reactions of eye irritation and increased lacrimation.1 If an artificial tear or other topical ophthalmic medications are used, they should be dosed at least 5 minutes apart from Vuity.
It is an exciting time for the treatment of presbyopia. The broad indication of Vuity with low risk of effect on the ocular surface allows the eye care practitioner to be comfortable prescribing this medication to appropriate patient candidates.
References:
- Vuity. Prescribing information. Allergan, Inc; Revised October 2021.
- de Paiva CS. Effects of aging in dry eye. Int Ophthalmol Clin. 2017;57(2):47-64. doi: 10.1097/IIO.0000000000000170
- Jain N, Verma A, Jain N. Formulation and investigation of pilocarpine hydrochloride niosomal gels for the treatment of glaucoma: intraocular pressure measurement in white albino rabbits. Drug Deliv. 2020;27(1):888-899. doi: 10.1080/10717544.2020.1775726
- Mitra AK, Mikkelson TJ. Mechanism of transcorneal permeation of pilocarpine J Pharmaceutical Sci. 1988;77(9):771-775. doi: 10.1002/jps.2600770911
- Anderson RA, Cowle JB. Influence of pH on the effect of pilocarpine on aqueous dynamics. Br J Ophthalmol. 1968;52(8):607-611. doi:10.1136/bjo.52.8.607
- Giyanani JS, Shabaik Y, Penzner J, Gore A. Novel, fast-equilibrating, ophthalmic vehicle for enhanced patient comfort and tolerability for pilocarpine delivery. PharmSci360. October 26-November 5, 2020. Accessed January 21, 2022.