Encore Vision Announces Successful Phase I-II Study of Topical EV06 for the Treatment of Presbyopia
- First clinical study of medical treatment aimed at the root cause of presbyopia
- Superior efficacy in visual outcomes observed with EV06 at 15 days continuing through 90 days
- EV06 was safe and well-tolerated with no treatment-related study discontinuations
05 May, 2016, 11:00 ET
FORT WORTH, Texas, May 5, 2016 /PRNewswire/ -- Encore Vision, Inc., a privately-held ophthalmic pharmaceutical company, presented positive results today during the Ophthalmic Innovation Summit from their Phase I-II study evaluating the safety and efficacy of EV06 ophthalmic solution 1.5%. EV06 is a novel topical therapy that targets presbyopia by restoring crystalline lens flexibility, thereby allowing the lens to focus on nearby objects.
After 3 months of twice-daily treatment with one drop of EV06 (n=50) or placebo (n=25), subjects in the EV06 group demonstrated improvement in all distance corrected near vision acuity (DCNVA) efficacy measures. By Day 91, 82% had 20/40 DCNVA or better in the EV06 group compared to 48% in placebo, with baseline values of 30% and 28%, respectively. Similarly, 60% of EV06-treated subjects had 20/32 DCNVA or better at Day 91 compared to only 24% in placebo; the baseline value for this measure in both groups was 8%. Additionally, more than double the amount of subjects in the EV06 group had combined DCNVA scores of 20/20 and 20/25 at Day 91 compared to placebo (36%-EV06; 16%-placebo), and these were both 0% at baseline.
A significant improvement from baseline in DCNVA in favor of EV06 was evident as early as Day 15 (p=0.017). DCNVA in the EV06 group improved from 0.397 LogMAR at baseline to 0.206 LogMAR at Day 91, which was significantly better than the placebo group (0.408 LogMAR at baseline to 0.313 LogMAR at Day 91; p=0.005). Lastly, a statistically significant proportion of subjects treated with EV06 gained 10 or more letters (DCNVA) by Day 15 (28%) compared to zero subjects in the placebo group (p=0.003). This trend continued throughout the study period and by Day 91, 36% of subjects gained 10 or more letters in the EV06 group compared to 16% of patients in the placebo group.
Dr. Richard L. Lindstrom, founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota, Department of Ophthalmology commented, "The positive results in favor of EV06 across multiple safety and efficacy endpoints provide a positive step forward in the development of the first ophthalmic drop addressing the root cause of presbyopia."
Bill Burns, President and Chief Executive Officer of Encore Vision, Inc. stated, "A follow-on study at days 120 and 270 post-dosing is now underway to assess the duration of EV06 treatment effect among subjects who participated in the prospective multicenter study just completed. Initial results will be reviewed and reported later in 2016."
EV06 was very well tolerated in the study population, with an average comfort rating of 3.0 (scale of 0-10; 0=very comfortable). This was comparable to the placebo group, which had an average comfort rating of 2.7. There was no change in best correct distance visual acuity, and no subjects discontinued the study due to adverse events, safety concerns, or tolerability.
"It is projected that nearly 2 billion people globally will have presbyopia by 2050, with the U.S. prevalence rising to over 120 million," said Mr. Burns. "Topical EV06 has the potential to address a massive unmet need and improve quality of life by restoring near vision and lessening or even eliminating patient dependence on 'readers'. We are encouraged by these promising results and will continue on our clinical development path toward initiating the next round of clinical studies, ultimately leading to a New Drug Application."
Presbyopia is the natural, gradual loss of the eye's ability to focus on nearby objects. It is generally noticeable around 40 to 45 years of age and caused by a stiffening of the lens of the eye. To focus on nearby objects, the human crystalline lens must be flexible enough to change shape by thickening at its center and increase its focusing power, which is referred to as accommodation. With age, the lens stiffens and loses elasticity thereby losing accommodative focusing power, manifesting in presbyopia. Presbyopia can have multiple effects on quality of vision and quality of life and if uncorrected, results in an inability to perform once-effortless near tasks at a customary working distance without experiencing visual symptoms.
Presbyopia is the most prevalent eye condition in the United States and by age 45, has often advanced to the point where some type of optical correction, such as reading glasses or bifocals, is required. An estimated 1.2 billion people in 2010 worldwide had presbyopia, and this number is expected to soar to 2 billion by 2020. Although there are a number of approaches to managing the visual disability associated with presbyopia, all of the currently available treatments are compensatory rather than corrective.
About the EV06 Phase I-II Study
The Phase I-II prospective, randomized, double‐masked, multicenter study examined the safety and efficacy of EV06 compared to placebo over 90 days for the treatment of presbyopia. Four sites across the United States enrolled a total of 75 subjects between the ages of 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 study population included subjects who did not require any visual correction prior to the onset of presbyopia (i.e., emmotropes) as well as myopes and hyperopes. Subjects were randomized 2:1 to receive EV06 or placebo. Mean change in DCNVA and BCDVA was evaluated throughout the study, along with additional secondary outcomes.
About EV06 Ophthalmic Solution
EV06 (Lipoic Acid Choline Ester, 1.5%) is a first‐in‐class new chemical entity that targets a biochemical cause of presbyopia, believed to be associated with an increase in the formation of disulfide bonds between the crystalline proteins within lens fiber cells. EV06 is intended to increase lens flexibility by breaking these bonds, thereby restoring elasticity, allowing the lens to focus on nearby objects. EV06 is a prodrug that penetrates the cornea and is subsequently broken down into lipoic acid and choline, two naturally occurring substances. The lipoic acid in EV06 is reduced to dihydrolipoic acid in lens fiber cells and is responsible for breaking the disulfide bonds, therefore increasing lens flexibility. Administration of EV06 may potentially halt or reverse the stiffening that occurs, allowing the lens to maintain or regain its ability to accommodate.
About Encore Vision, Inc.
Encore Vision is a privately‐held eye care company focused on developing novel therapies for the treatment of presbyopia. Encore Vision's lead product candidate, EV06 ophthalmic solution, is based on its proprietary, patented pro‐drug technology that seeks to reverse the aging process responsible for presbyopia. In addition, Encore Vision is exploring additional methods and compounds to treat presbyopia. To learn more, visit http://www.encorevisioninc.com/.
SOURCE Encore Vision, Inc.
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