By Fineline Cube China-based ophthalmic therapies developer Arctic Vision announced the first patient enrollment in a Phase III clinical study for its ARVN003, a proprietary pilocarpine formulation leveraging its micro-dosing platform Optejet. The study aims to evaluate the efficacy and safety of ARVN003 in temporarily improving vision in adults with presbyopia (long-sightedness) in China.
Study Details
The double-masked, placebo-controlled, randomized, and multicenter Phase III trial is designed to assess the efficacy and safety of ARVN003. It marks the first clinical trial approved in China for presbyopia drugs and represents the first patient enrollment in a Phase III trial for such drugs in the country.
Drug Profile
ARVN003 is a proprietary pilocarpine formulation that uses the Optejet micro-dosing platform for the pharmacologic treatment of presbyopia. The pilocarpine ophthalmic solution constricts the pupil and improves near-distance vision by creating an extended depth of focus through its small aperture effect. The Optejet platform enhances tolerability and usability while providing improvement in near vision.
Licensing and Previous Trials
Arctic Vision obtained an exclusive license for the development and commercialization of ARVN003 (MicroLine) in Greater China and South Korea from US biopharma Eyenovia in August 2020. In May 2021, Eyenovia announced positive results from the first Phase III MicroLine study, VISION-1, in the US. The trial achieved its primary endpoint, with MicroLine showing a statistically significant improvement over placebo in high contrast binocular distance corrected near visual acuity measured in low light conditions two hours after treatment.-Fineline Info & Tech