Presbyopia Therapies Announces Primary Safety and Efficacy Endpoints met in a Phase IIb study of its Topical PRX Ophthalmic Solution for the Treatment of Presbyopia
CORONADO, Calif., July 30, 2018 /PRNewswire/ -- Presbyopia Therapies, LLC, a privately-held ophthalmic pharmaceutical company dedicated to developing therapies for the treatment of presbyopia, today announced that the primary efficacy and safety endpoints have been met in a Phase IIb study of its PRX ophthalmic solution. PRX demonstrated a three line or greater improvement in monocular distance corrected near acuity in patients between the ages of 48 and 64, with this improvement observed in some patients for up to seven hours.
"We are thrilled by the positive safety and efficacy outcomes observed throughout this well-controlled, randomized trial. It is estimated that approximately 1.8 billion people globally have presbyopia, including over 110 million in the US alone. PRX has the potential to address a massive unmet need by restoring near vision," said Gerald Horn, MD, Chief Scientific Officer of Presbyopia Therapies. "PRX demonstrated a statistically significant and clinically meaningful improvement in near visual function within 30 minutes. These data warrant rapid future clinical advancement."
This Phase IIb randomized, double-masked, placebo controlled study evaluated two unique miotic based test candidates of PRX versus placebo for the treatment of presbyopia. A total of 58 subjects participated in the study. At one hour after instillation, 47.2% of study eyes gained at least three lines (p<0.001) and 91.7% gained at least two lines of improvement in near vision (p<0.0001). Approximately one half of study eyes maintained a two line or greater improvement up to seven hours. This unique drug was well-tolerated, with no significant loss in monocular best corrected distance visual acuity in study eyes, and no serious adverse events.
The study was conducted by Ora, Inc. (Andover, MA. www.oraclinical.com), a leading global ophthalmic CRO. David A. Hollander, MD, MBA, Chief Medical Officer at Ora commented, "This presbyopia treatment showed a sustained three line improvement in near visual acuity. This medication has the advantage of a very quick onset – within 30 minutes of instillation. PRX may offer a much-needed alternative to spectacles, contact lenses and surgery for the growing worldwide presbyopic population."
Presbyopia is the natural, gradual loss of the eye's ability to focus on nearby objects. 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 1.8 billion people worldwide have presbyopia, including over 110 million in the US alone. Presbyopia can have multiple effects on quality of vision and quality of life and if uncorrected, results in an inability to perform once‐effortless tasks at a customary working distance without experiencing visual symptoms. 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. Currently, there are no FDA approved pharmaceutical treatments available for presbyopia.
About PRX Ophthalmic Solution
PRX eye drops are based on discoveries combining a proprietary vehicle with unique miotic combinations, without using pilocarpine. The drops are intended to induce strong miosis to create a significant pinhole effect with a depth of field enhancement, without any associated accommodative distance blur. PRX was developed to compliment current treatment options (not a permanent replacement for reading glasses, contact lenses or other options) and is reversible.
About Presbyopia Therapies, LLC
Presbyopia Therapies, LLC ("PT" or "the Company") is privately-held ophthalmic pharmaceutical company dedicated to developing therapies for the treatment of presbyopia. PT's lead product candidate may provide a powerful topical presbyopic treatment with improved near vision while maintaining distance vision for total depth of field enhancement. PRX eye drops could create a new "disruptive" global market category for the daily treatment of presbyopia. To learn more, contact Jim McCollum at firstname.lastname@example.org.