During a session at the ASCRS meeting in Boston this weekend, Kathryn M. Hatch, MD, ABO, discussed the state of presbyopia-correcting drops. Two drops have been approved by the U.S. Food and Drug Administration (FDA) for use in the United States: Vuity (Allergan/AbbVie) in October 2021 and Qlosi (Orasis Pharmaceuticals) in October 2023.
Despite initial “buzz” and anticipation surrounding the Vuity approval, the response has been somewhat mixed, noted Dr. Hatch, an assistant professor of ophthalmology at Harvard Medical School and director of the refractive surgery service at Massachusetts Eye and Ear in Boston. This is in part due to widespread media reports of side effects in some patients, which can range from headaches to hyperemia and retinal detachment, The relatively short duration of effect — about three to four hours with once-a-day dosing — was also disappointing. As a result, prescriptions for Vuity have fallen off sharply.
Both Vuity and Qlosi are miotic solutions, and Dr. Hatch says that doctors have determined the types of patients who do not make good candidates for presbyopia-correcting drops. Patients with high myopia (long axial length), a previous retinal tear or a history of retinal pathology should avoid the drops, she says. The drops are more suitable for emmetropes, including post-refractive emmetropes. Patients with low hyperopia to mild myopia and no history of retinal pathology who have already had a monofocal intraocular lens (IOL) implanted may choose drops instead of reading glasses, while premium IOL patients may find that the drops provide additional near vision beyond what their surgery provided. Dr. Hatch says that side effects like headache or dim vision generally go away after a week of consistently taking the drops.
Several drops are currently in clinical trials, but Dr. Hatch says that an aceclidine drop being developed by Lenz Therapeutic is particularly promising. “It is unique because it is pupil selective and doesn’t seem to cause the headaches,” she said. Last week, Lenz released topline data from its phase 3 CLARITY study; the LNZ100 formulation (1.75% aceclidine) achieved the primary endpoints and key secondary endpoints, with statistically significant three-lines-or-greater improvement in best-corrected distance visual acuity at near, without losing one line or more in distance visual acuity. LNZ100 also lasts up to 10 hours. The company plans to submit a new drug application to the FDA in mid-2024.1
“It’s exciting, because it’s a different compound,” said Dr. Hatch. “And I do think that something that is more pupil selective and can last for a longer time could be a game changer” when it comes to presbyopia-correcting eyedrops.
1. LENZ Therapeutics announces positive topline data from phase 3 CLARITY presbyopia trials. Press release. April 03, 2024. Accessed April 7, 2024. https://ir.lenz-tx.com/news-events/press-releases/detail/11/lenz-therapeutics-announces-positive-topline-data-from-phase-3-clarity-presbyopia-trials