ProHeal Pharma Initiates Phase II Clinical Trial of PHP0101 Ophthalmic Solution for Presbyopia

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Pro-heal Pharmaceuticals has initiated a Phase II clinical study evaluating the efficacy, safety, and local pharmacokinetics of different concentrations of PHP0101 eye drops for treating Chinese patients with presbyopia. The study is randomized, double-blind, and placebo-controlled. The clinical trial registration number is CTR20253762, with the initial information disclosure date on September 19, 2025.

The drug formulation is eye drops, with a specification of 0.4ml/bottle. The administration method is one drop for both eyes, once daily, administered into the conjunctival sac. The treatment duration is 28 consecutive days (±2 days). The primary objective of this trial is to evaluate the efficacy of different concentrations of PHP0101 eye drops in treating Chinese patients with presbyopia, compared to placebo, to provide a basis for subsequent clinical recommended dosing. The secondary objectives are to assess its efficacy, safety, and local pharmacokinetics; the exploratory objective is to evaluate its efficacy in treating dry eye.

PHP0101 Eye Drops is a chemical drug indicated for presbyopia. Presbyopia, also known as farsightedness due to aging, is a physiological phenomenon where the elasticity of the crystalline lens decreases and the function of the ciliary muscle diminishes with age, leading to reduced eye accommodation and difficulty in near vision. It generally begins after the age of 40 and can be diagnosed through optometric examination.

The primary endpoint of this trial was the proportion of subjects whose near vision (DCNVA) under best-corrected distance vision in both eyes improved by 3 lines or more from baseline, measured 3 hours after medication on Day 28 under mesopic vision and high-contrast conditions. Secondary endpoints included the proportion of vision improvement at different time points, changes in letter count, diopter adjustments, pupil diameter variations, as well as the incidence and severity of adverse events, results of various examinations, tear drug concentration, and pharmacokinetic parameters.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 120 participants.

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Editor: Xiaolang Express