Presbyopia Therapies announced that the primary efficacy and safety endpoints have been met in a phase 2b study of its PRX ophthalmic solution. PRX demonstrated a 3 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 7 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 2b 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 1 hour after instillation, 47.2% of study eyes gained at least 3 lines (P < 0.001) and 91.7% gained at least 2 lines of improvement in near vision (P < 0.0001). Approximately one half of study eyes maintained a 2 line or greater improvement up to 7 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, a global ophthalmic CRO. David A. Hollander, MD, MBA, Chief Medical Officer at Ora commented, “This presbyopia treatment showed a sustained 3 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.”