Lexitas Pharma Services and Ocusun have enrolled the first patient in a US pilot study evaluating an investigational eye drop being developed as a potential treatment for age-related cataract.
The multicentre, randomized, double-masked, placebo-controlled study is assessing the safety and efficacy of ZOC2017217 in people with age-related cataract. The pilot study is intended to support an upcoming pivotal phase III trial and is registered on ClinicalTrials.gov.
The first patient was enrolled at North Bay Eye Associates in Petaluma, California, under the direction of Dr. Jason Bacharach.
Cataract remains one of the leading causes of vision loss and blindness worldwide. According to the World Health Organization, more than 94 million people globally are affected by cataract. The condition typically develops with age and is a major source of healthcare spending, with cataract treatment estimated to account for $3.4bn to $3.6bn in annual Medicare expenditure in the United States.
Surgery is currently the only viable treatment option for cataract. ZOC2017217 is being developed as a topical eye drop designed to help inhibit, and potentially reverse, cataract progression, with the aim of reducing the burden of prolonged vision impairment and expanding future treatment options.
Terrence Li, chief medical officer and chief operating officer of Ocusun, said the first patient enrollment marked an important milestone for the program. He said the investigational treatment builds on exploratory data from China, where 50.0% to 86.4% of participants achieved visual acuity of 20/40 or better 12 to 24 weeks after treatment.
“ZOC2017217 indicates a potential alternative treatment approach that could reshape the landscape of cataract care,” Li said. "By pioneering this innovative development strategy, our objective is to deliver a new treatment option that addresses the significant unmet need for age-related cataract treatment globally."
Bacharach, medical director of North Bay Eye Associates and an investigator in the trial, said addressing visual function decline before surgery is a “critical frontier” in ophthalmic care. "ZOC2017217 offers a first-of-its-kind pharmacological approach to managing cataract progression,” Bacharach added. “I anticipate that this innovative therapy will significantly expand our clinical toolkit and fundamentally advance how we protect patient vision globally."
Jeanne Hecht, chief executive of Lexitas Pharma Services, said the development of a potential non-surgical cataract treatment represents an opportunity to advance patient care. "We are proud to support Ocusun in generating the clinical evidence needed to assess the potential of this innovative therapy and help inform the program's continued development," she said.
ZOC2017217 is derived from lanosterol, a naturally occurring sterol. Ocusun said preclinical studies suggest the therapy may improve antioxidant activity, inhibit protein misfolding and aggregation linked to cataract formation, and reduce lens opacity.
Source: PR Newswire.
