Arctic Vision has enrolled the first subject in a Phase III clinical trial of ARVN003 to temporarily boost vision in adults with presbyopia in China.
ARVN003 is a proprietary pilocarpine formulation that uses the company’s micro-dosing platform, Optejet.
The ophthalmic solution is said to constrict the pupil and enhance near-distance vision by extending the depth of focus through its small aperture effect.
Optejet is used to administer pilocarpine to offer improvement in near vision while boosting tolerability and usability.
The placebo-controlled, randomised, multicentre, double-masked trial will analyse the safety and efficacy of ARVN003 to provide temporary vision improvement in adults with presbyopia.
This is the first trial to obtain approval in China for presbyopia drugs and is the first Phase III trial of these drugs to enrol subjects in China.
Arctic Vision co-founder and chief medical officer Dr Qing Liu said: “ARVN003’s significant clinical progress is encouraging.
“We strive to make ARVN003 the first approved presbyopia drug in China and benefit more presbyopia patients with innovative and diverse treatment options that will help them see and live better.”
In August 2020, the company obtained an exclusive licence from Eyenovia to develop and market ARVN003 (MicroLine) in Greater China and South Korea.
According to the positive data reported by Eyenovia from a Phase III VISION-1 trial of MicroLine in the US, the primary endpoint was met.
Furthermore, MicroLine 2% was demonstrated to be statistically superior to placebo, as assessed by improvement in high contrast binocular distance corrected near visual acuity evaluated in low light conditions two hours following treatment.
A physiological condition, presbyopia is caused when the lens becomes harder and ciliary muscle becomes weaker.
In November last year, the company dosed the initial set of participants in a Phase III trial of ARVN001 to treat macular oedema linked with uveitis in China.