The PRX ophthalmic solution from Presbyopia Therapies LLC demonstrated a statistically significant three line or greater improvement in monocular distance corrected near visual acuity in a phase 2b trial, meeting primary efficacy and safety endpoints, the company announced in a press release.
Conducted by Ora Inc., the randomized, double-masked, placebo-controlled study enrolled 58 patients between the ages of 48 and 64 years and evaluated two unique miotic-based PRX test candidates, the release said.
One hour after instillation, 47.2% of study eyes gained at least three lines (P < .001), while 91.7% gained at least two lines of near visual acuity. At least a two-line improvement was maintained for up to 7 hours in about half of study eyes, according to the release.
“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 release stated.