Presbyopia Eye Drop Targets Miosis and Accommodation
Refractive Surgery Outlook | February 2016
By Diane Donofrio Angelucci
Recently, we featured 2 miotic drops that show promise as a treatment for presbyopia, PRX-100 and Presbyeyedrops. Both offer nonsurgical, reversible presbyopia correction, without the side effects of typical pupil restrictors and without affecting contrast sensitivity.
Broadening the field of contenders is PresbyPlus™ and PresbV (Presbyopia Vejarano) Tears, which can also induce accommodation.
“Miosis is a phenomenon consequential to the properties of the drops, but miosis alone is not enough to solve presbyopia,” said Roberto Pinelli, MD, who developed PresbyPlus. “We also need accommodation.”
The proprietary components of PresbyPlus stimulate the ciliary muscle to accommodate and constrict the pupil, said Dr. Pinelli, founder and CEO of the Switzerland Eye Research Institute in Lugano, Switzerland. Ingredients include a mix of 2 parasympatho mimetics and 1 parasympatho lytic (balanced concentration).
PresbyPlus is designed for presbyopic emmetropes, aged 45 to 60 years, who require +0.50 to +1.50 D of correction. The drops are instilled bilaterally twice a day, in the morning and evening.
A clinical trial of PresbyPlus showed that 90% of subjects could see J4 to J1. Patients were followed for 1 year and no adverse reactions were observed.
PresbyPlus is counterindicated in patients with cataracts, retinal diseases, glaucoma and in patients with refractive errors greater than -1.0 D sph and +1.50 D sph.
Though not an alternative to surgery, the drops may allow clinicians to manage early presbyopia without reading glasses, Dr. Pinelli said. PresbyPlus could treat emmetropes with a history of LASIK or cataract surgery.
Dr. Pinelli believes the drops could even delay cataracts due to the induced accommodative effect. “We all know that any organ, if used, maintains its capabilities,” he said.
“I also use PresbyPlus in my eyes. I’m 56 years old and I can see 20/20 and J1 without glasses,” Dr Pinelli said.
Dr. Pinelli has applied for patents in Switzerland.
PresbV Tears produce true accommodation and mild dynamic miosis, said its inventor, L. Felipe Vejarano, MD, associate professor of ophthalmology, University of Cauca, Popayán, Colombia.
“With these drops, the pupil is active all of the time. It is not spasmodic, not fixed. It’s totally active and dynamic,” he said. “They are very promising, very safe, and easy to use.”
This drop is also for emmetropes with early presbyopia, and administered bilaterally twice a day, in the morning and afternoon, as the drops are effective for 4 to 5 hours. In a photopic setting the pupil constricts to 2.5 mm, and in a scotopic environment it dilates to 4 mm.
A preliminary prospective study including 20 presbyopic emmetropes (5 patients with a history of LASIK and 6 who had PresbV LASIK) showed improvement in near (3 lines) and far (1 line) uncorrected visual acuity. Accommodation ranged from 1.25 to 1.75 D.
An hour after instillation, researchers observed minor changes in pupil size and anterior chamber depth, mild myopic shift (-0.50 D) and corneal steepening (0.2 - 0.3 D). Schirmer’s test and endothelial cell count were unchanged. Four hours after instillation, mean intraocular pressure decreased by 2 mmHg.
Dr. Vejarano subsequently measured intermediate vision in other subjects who could see 20/25 or better.
Dr. Vejarano, age 48, experienced a 0.75 D improvement in his range of accommodation since he began using the drops about 5 years ago. His visual acuity is 20/20 for distance and near without drops.
“My theory is that because I am exercising the ciliary muscle it is better than 3 years ago and 5 years ago,” he said. “That’s why right now I can see better near without drops. Of course, with the drops it improves more.”
During the last 3 years, his IOP decreased by 1.5 mmHg, while lacrimal film, meniscus and endothelial cell counts showed no adverse effects. He experienced no redness or discomfort.
Dr. Vejarano has applied for a patent in 10 countries.The principal component is a parasympathetic mixed with many others to avoid ciliary spasm.
He expects PresbV Tears to be available in Colombia in early 2016. A 3-month European clinical trial is planned. Future studies could investigate the effects in patients with accommodative or multifocal IOLs.
Discussions with large compounding pharmacies to manufacture the drops in various countries are underway. Because each component is approved by the U.S. Food and Drug Administration, additional clinical trials will not be required, he said.
Dr. Pinelli, inventor and developer of PresbyPlus™ drops, is the owner of the patent; he has a financial interest in the product and is founding a company for producing PresbyPlus™. Dr. Vejarano, developer of PresbV Tears, has a financial interest in his product and is forming a related company.