FORT WORTH, Texas—A clinical trial for eye drops that reverse the symptoms of presbyopia has shown positive results.

Encore Vision, a privately‐held ophthalmic pharmaceutical company based here that developed the innovative eye drops, reported that “primary efficacy and safety endpoints have been met in its Phase I‐II proof of concept study” of EV06 ophthalmic solution 1.5 percent,” the main ingredient in the eye drops.

According to Encore Vision, EV06 is the first topical medical treatment directed at softening the gradual stiffening of the crystalline lens, a major underlying cause of presbyopia, the natural, gradual loss of the eye’s ability to focus on near objects that starts to affect people at about age 40.

“We are encouraged by the positive safety and efficacy outcomes observed throughout the study in patients treated with EV06,” said Bill Burns, Encore Vision’s president and CEO. “EV06 demonstrated a safety profile nearly identical to placebo and a significant ability to improve near vision function as early as two weeks. We believe these data warrant future clinical development.”

Encore Vision’s clinical trial involved 75 subjects between ages 45 and 55 with distance corrected near visual acuity (DCNVA) worse than 20/40 and best corrected distance visual acuity (BCDVA) of 20/20 or better in each eye. The company said it observed a significant improvement of DCNVA from baseline in the EV06 group compared to placebo, with onset of DCNVA improvement beginning at day 15 and continuing throughout the 90-day study period.

“We have reversed presbyopia, quite clearly,” Burns told VMail. “We have restored binocular near vision in a nice proportion of presbyopic subjects whose pre-treatment vision was worse than 20/40.” According to Burns, there are 45 million to 57 million presbyopes in the U.S. between ages 45 and 55 who would be Encore Vision’s initial target market.

Burns said Encore Vision is studying the results of the clinical trials with the intent of gaining a better understanding of the proper dosages for EV06 and learning whether a longer duration of treatment would improve patient outcome. He said the company hopes to meet with FDA officials later this year who will help it shape the next phase of research which will hopefully lead to FDA approval and commercialization.

Burns will present additional clinical results tomorrow during the Ophthalmology Innovation Showcase at the 2016 Ophthalmology Innovation Summit at the American Society of Cataract and Refractive Surgeons Symposium in New Orleans.

Founded in 2000, Encore Vision is an affiliate of The Egg Factory, a Roanoke, Va. company that incubates new technologies in optics and ophthalmics.