Lexitas Pharma Services and Chinese partner Ocusun have enrolled the first patient in a multicenter pilot study evaluating ZOC2017217, an investigational topical therapy for cataracts that could offer a non-surgical treatment approach if successful.
The randomized, double-masked, placebo-controlled study is designed to assess the efficacy and safety of ZOC2017217 in patients with age-related cataract and will help inform the design of an upcoming pivotal phase 3 program. The first participant was enrolled at North Bay Eye Associates in Petaluma, California, by investigator Jason Bacharach, MD. The trial is registered on ClinicalTrials.gov (NCT07395986)
ZOC2017217 is being developed as a topical eye drop intended to inhibit or potentially reverse cataract progression, with the goal of delaying or reducing the need for surgery.
"Addressing visual function decline at the pre-surgical stage is a critical frontier in ophthalmic care," said Dr. Bacharach, medical director of North Bay Eye Associates and an investigator in the trial. "ZOC2017217 offers a first-of-its-kind pharmacological approach to managing cataract progression. I anticipate that this innovative therapy will significantly expand our clinical toolkit and fundamentally advance how we protect patient vision globally."
"The enrollment of our first patient marks an important milestone for the ZOC2017217 program, building on encouraging data from our exploratory study in China where 50% to 86.4% of participants achieved a visual acuity of 20/40 or better 12 to 24 weeks post-treatment," said Terrence Li, chief medical officer and chief operating officer of Ocusun. "ZOC2017217 indicates a potential alternative treatment approach that could reshape the landscape of cataract care."
ZOC2017217 is derived from lanosterol, a naturally occurring sterol that has been investigated for its potential role in preventing or reversing cataract formation. According to Ocusun, preclinical studies demonstrated that the therapy improved antioxidant activity and inhibited protein misfolding and aggregation associated with cataract development, resulting in reduced lens opacity. Early clinical findings also suggest the eye drop may improve visual function, decrease lens opacity, and enhance vision-related quality of life in patients with age-related cataracts.
The study is currently enrolling participants at multiple clinical sites. Physicians interested in referring eligible patients can contact Lexitas Pharma Services at RecruitmentE06@lexitas.com for additional information.