Pre-clinical and clinical assessment EV06 ophthalmic solution (EV06; lipoic acid choline ester, 1.5%) for improving distance-corrected near vision acuity (DCNVA) in presbyopes

Session Details

Session Title: Presbyopia Correction

Session Date/Time: Tuesday 13/09/2016 | 16:00-18:00

Paper Time: 16:12

Venue: Auditorium A

First Author: : J.Hunkeler USA

Co Author(s): :    R. Lindstrom   K. Crawford   D. Evans   J. Stein   A. Glasser   W. Burns     

Abstract Details

Purpose:

This presentation will summarize a unique research and development program to support a non-invasive, pharmaceutical treatment of presbyopia. EV06 (1.5%; lipoic acid choline ester, LACE) is a topical ophthalmic solution designed to attenuate or reverse age-related changes in the crystalline lens that result in diminished lens elasticity. EV06 is intended to decrease lens stiffness and thus allow visual accommodation to near vision stimuli. The presentation will discuss pre-clinical safety and effectiveness evidence and the preliminary results of a Phase I/II clinical study in presbyopes.

Setting:

Laboratory, pharmacology and toxicology studies evaluated safety and in-vitro efficacy. A multi-site clinical study was conducted by ophthalmologists and optometrists in four private practice setting offices located in Memphis, Tennessee; Washington, Missouri; Mission Hills, California; Artesia, California, USA.

Methods:

In-vitro studies assessed chemical agents on lens disulfide bonding and elasticity. In vivo, a LACE formulation (2.5µL; 5%) or placebo was applied 3x per day for 5 weeks to mice. In a prospective, 90-day clinical study, eligibility included age (45-55), distance corrected visual acuity (DCNVA ;> 20/40), astigmatism (<0.75D) and manifest refraction spherical equivalent (+4.0D). Randomized subjects used either EV06 or placebo (2:1). Clinical parameters evaluated include standard assessments of ocular safety (e.g., anterior segment and fundus exams), comfort, both subjective and objective assessments of accommodative amplitude (aberometer, defocus curve) and distance and near vision (EDTRS).

Results:

Pre-clinical evidence showed decreases in lens disulfide bonding, increases in lens elasticity and an acceptable safety profile. All 75 enrolled subjects have completed the clinical study. Only 3 subjects were discontinued -none due to treatment-related events. EV06 was well tolerated as evidenced by acceptable levels of instillation comfort, the absence of positive corneal or fundus findings and the absence of serious adverse events. There were no changes to distance or near visual acuity that required discontinuation from the study. Statistical analysis is in-progress. DCNVA, defocus curve, accommodative amplitude and other efficacy results will be reported.

Conclusions:

Topical treatment of EV06 Ophthalmic Solution (1.5%; bid) for presbyopia presents a promising new approach for the modulation of near vision loss and restoration of accommodative function for a population of potential candidates for this emerging therapy.

Financial Disclosure:

... has significant investment interest in a company producing, developing or supplying product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... is employed by a for-profit company with an interest in the subject of the presentation