Arctic Vision's Investigational Drug ARVN003 Receives Approval for Phase 3 Clinical Trial in Presbyopia Treatment

Text | Pharma Observer

On September 3, Arctic Vision announced that the Investigational New Drug (IND) application for a Phase III clinical trial of ARVN003 (low-concentration pilocarpine ophthalmic solution) for the treatment of presbyopia has been approved by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). According to the press release, this is the first clinical trial for a presbyopia drug approved in China. The primary objective of the trial is to evaluate the efficacy and safety of ARVN003 in temporarily improving near vision in patients with presbyopia.

Presbyopia is caused by age-related hardening of the crystalline lens, leading to a gradual decline in the eye's ability to focus on near objects, and it cannot be prevented. Current treatment modalities are primarily device- or surgery-based, such as reading glasses, contact lenses, corneal surgery, and multifocal intraocular lens (IOL) implantation. However, irreversible invasive surgical procedures carry inherent risks associated with surgery. Consequently, there is significant patient interest in an effective and safe pharmacological treatment for presbyopia.

ARVN003 is a pharmacological therapy for presbyopia. The well-established efficacy of pilocarpine ophthalmic solution in improving near vision through pupillary constriction (miosis) relies on an expanded depth of focus generated by the pinhole effect. The development of ARVN003 integrates pilocarpine with the Optejet® micro-dosing delivery system, which utilizes MAP™ (Microdose Array Print) micro-array drug film technology, effectively addressing tolerability and bioavailability limitations associated with the administration of the same drug via conventional eye drops.

In August 2020, Arctic Vison obtained an exclusive license from Eyenovia for the development and commercialization of ARVN003 (also known as MicroLine) and ARVN002 (also known as MicroPine) in Greater China and South Korea. In May 2021, Eyenovia announced that MicroLine achieved positive topline results and met the primary endpoint in the Phase 3 VISION-1 study for the treatment of patients with presbyopia, and is currently preparing for the second Phase 3 clinical trial, VISION-2.

References

[1]Arctic Vison Receives Approval for China's First Phase III Clinical Trial Application of Presbyopia Drug Therapy ARVN003. Retrieved Sep 3, 2021, from https://mp.weixin.qq.com/s/j0zM_lsU3oj2YfhBtSHc8A

(Original text has been abridged)

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