Lexitas and Ocusun Launch Pilot Study of Lanosterol-Derived Eye Drop for Age-Related Cataract
核心洞察
Lexitas Pharma Services (搜索) and Ocusun (搜索) have enrolled the first patient in a multicenter, randomized, double-masked, placebo-controlled pilot study (NCT07395986) evaluating ZOC2017217, an investigational topical eye drop for age-related cataract (搜索).
ZOC2017217 is derived from lanosterol, a naturally occurring sterol that in preclinical studies improved antioxidant activity, inhibited protein misfolding, and reduced lens opacity.
In an earlier exploratory study in China, 50.0% to 86.4% of participants achieved visual acuity of 20/40 or better at 12 to 24 weeks post-treatment.
Lexitas Pharma Services (搜索) and Ocusun (搜索) have announced the enrollment of the first patient in a pilot study evaluating ZOC2017217, an investigational topical eye drop designed as a potential non-surgical treatment for age-related cataracts. The first patient was enrolled at North Bay Eye Associates, Inc. in Petaluma, California, under the direction of Jason Bacharach, MD.
The multicenter, randomized, double-masked, placebo-controlled pilot study (NCT07395986) is designed to inform an upcoming pivotal phase III trial. It will assess the efficacy and safety of ZOC2017217 in participants with age-related cataract (搜索).
The Unmet Need in Cataract Care
According to the World Health Organization, over 94 million people worldwide are affected by cataract, making it one of the leading global causes of vision loss and blindness. Cataract treatment accounts for an estimated $3.4–$3.6 billion in annual Medicare spending, representing one of the most significant sources of ophthalmic healthcare expenditure. Currently, surgery remains the only viable treatment solution.
"Addressing visual function decline at the pre-surgical stage is a critical frontier in ophthalmic care," said Jason Bacharach, MD, 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."
Mechanism and Preclinical Rationale
ZOC2017217 is derived from lanosterol, a naturally occurring sterol that has demonstrated potential to address cataract formation. In preclinical studies, the therapy significantly improved antioxidant activity and inhibited protein misfolding and aggregation associated with cataract formation, thereby reducing lens opacity. Ocusun (搜索) holds the U.S. patent for a crystal form of a lanosterol compound drug.
Early clinical findings also suggest that ZOC2017217 may improve visual function, reduce lens opacity, and enhance vision-related quality of life in patients with age-related cataract (搜索).
Prior Clinical Data
Terrence Li, Ocusun (搜索)'s chief medical and operating officer, noted that an exploratory study conducted in China found the eye drop was associated with "50.0% to 86.4% of participants achieved a visual acuity of 20/40 or better 12 to 24 weeks post-treatment."
"ZOC2017217 indicates a potential alternative treatment approach that could reshape the landscape of cataract care," Li added. "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 (搜索) treatment globally."
Study Design and Endpoints
The pilot study will enroll an estimated 40 patients aged 50 and older. Participants will be randomized 1:1 to self-administer either 0.4% ZOC2017217 or a placebo into both eyes twice daily for 24 weeks. The study eye—the eye meeting eligibility criteria—will be used for efficacy analyses. Patients who have previously undergone cataract surgery in their non-study eye, or whose non-study eye is deemed unsuitable for treatment, will only administer the drop in their study eye.
Primary outcomes, measured from baseline at Weeks 4, 12, and 24, include best-corrected distance visual acuity (BCDVA), contrast sensitivity, visual function questionnaire (VFQ-25) scores, and crystalline lens opacity. BCDVA will also be assessed based on the number of patients who gain or lose ≥5, ≥10, or ≥15 letters, and those achieving BCDVA of ≥0.3, 0.1, or 0.0 LogMAR (Snellen: 20/40, 20/25, or 20/20).
Secondary outcomes focus on safety and adverse event monitoring, both ocular and non-ocular, as well as clinically relevant changes from the start of treatment through study exit. Patients who develop new or ongoing ocular adverse events at Week 24 will be asked to return 14 days later for a safety follow-up evaluation.
Timeline and Partnerships
ClinicalTrials.gov currently estimates the study's primary completion for March 2027, with full study completion expected in May 2027.
"Cataracts remain one of the leading causes of vision impairment worldwide, and the development of a potential non-surgical treatment represents an exciting opportunity to advance patient care," said Jeanne Hecht, Chief Executive Officer of Lexitas Pharma Services (搜索). "We are proud to support Ocusun (搜索) in generating the clinical evidence needed to assess the potential of this innovative therapy and help inform the program's continued development."
Lexitas, a QHP Capital portfolio company, is a full-service ophthalmology-focused CRO providing trial design and management, regulatory strategy, ophthalmic imaging and reading center services, site and investigator management, medical monitoring, and data management. Ocusun (搜索), headquartered in Guangzhou, China, specializes in ophthalmic pharmaceuticals targeting conditions including glaucoma and cataracts, with a patent portfolio encompassing over 200 patent applications filed globally.