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Topical treatment for presbyopia improves binocular near acuity

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LOS ANGELES — A first-in-class topical treatment for presbyopia was well tolerated and safely improved binocular near acuity in a phase 1/2 trial, according to a speaker.

EV06 ophthalmic solution (lipoic acid choline ester, 1.5%; Encore Vision/Novartis) improved bilateral distance-corrected near vision compared with placebo in the 3-month, prospective, randomized, double-masked multicenter study.

Richard L. Lindstrom

“It is the first therapy that can reverse presbyopia in a natural and safe fashion,” Richard L. Lindstrom, MD, said at the American Society of Cataract and Refractive Surgery meeting. “It will be an extremely important step forward in ophthalmology.”

EV06 is a prodrug that penetrates the cornea and is metabolized into an organic compound able to naturally “un-crosslink” the crystalline lens and make it more elastic. In the study, EV06 demonstrated efficacy in improving binocular near acuity in 50 patients.

“Significant improvement was seen as early as at 8 days and continued over 3 months, with no loss of distance vision. Eighty-four percent of the patients gained at least one line and achieved 20/40 or better, and more than half of the patients gained two lines or more,” Lindstrom said.

After study completion, patients were followed up for a further 7 months. The effect persisted, with just a small decline.

“We need further studies to establish how long we should treat the patients to obtain maximum improvement, and maybe administer a reduced dose thereafter to retain the effect,” Lindstrom said.

None of the patients discontinued the study, only a few reported mild irritation at the moment of instillation, and no changes in IOP or pupil diameter occurred.

Reference:

EV06 ophthalmic solution. An eye drop for bilateral treatment of presbyopia. Presented at: American Society of Cataract and Refractive Surgery annual meeting; May 5-9, 2017; Los Angeles.

Disclosure: Lindstrom is founder and member of the board of directors of Encore Vision and is a consultant for Novartis.