Lexitas Pharma Services and Ousun shared that patient dosing is officially underway for an ongoing pilot study evaluating an investigational eye drop for the potential treatment of age-related cataracts.
An eye drop for cataracts?! Wow … but first, let’s talk about these players.
We’ll begin with Lexitas. As a QHP Capital portfolio company, this specialized clinical research organization (CRO) supports pharma, biotech, and device companies in designing and running ophthalmic trials for investigational drugs, devices, and therapies.
Its offerings include an ophthalmology-focused team, tailored operating procedures, and full-cycle guidance across ophthalmic subspecialties throughout clinical development.
- Among its services: trial design and management, regulatory strategy, ophthalmic imaging and reading center work, site/investigator management, medical monitoring, and data management/analysis.
And wasn’t Lexitas just in the news?
Relatively recently (May 2026). The CRO acquired Erie Retina Research, an ophthalmic clinical research center specializing in retinal diseases and vitreoretinal surgery, along with its two assets:
- CASExERIE, LLC (an ophthalmic innovation hub)
- Element Erie: Imaging & Reading Center PLLC
Noted! Next up: Ocusun.
Operating out of Guangzhou, China, the ophthalmic pharmaceutical company specializes in research and development, production, and sales of therapeutics that address unmet needs.
- Its patent portfolio encompasses 200+ patent applications filed across the globe—including in the United States. Get a look at its integrated technology platform.
- Among the target conditions of its treatments: glaucoma and cataracts.
Now let’s talk about this investigational drop.
That would be ZOC2017217, derived from a naturally-occurring steroid molecule called lanosterol.
- Its ophthalmic tie-in: Lanosterol helps dissolve crystalline (cloudy protein clumps) that form cataracts in the eye lens.
- Also important to note: Ocusun owns the U.S. patent for a crystal form of a lanosterol compound drug.
Is there any prior clinical data on it?
Indeed there is—preclinical and early clinical findings, to be exact.
Those preclinical outcomes: The eye drop significantly improved antioxidant activity as well as preventing protein misfolding and aggregation associated with cataract formation.
- As a result, it reduced lens opacity.
And the early clinical outcomes: These also suggest that the drop may lead to three key benefits for patients with age-related cataract:
- Improved visual function
- Reduced lens opacity
- Enhanced vision-related quality of life (QoL)
Go on …
Terrence Li, Ocusun’s chief medical and operating officer, further 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,” he added.
Let’s move on to this upcoming trial.
The multicenter, randomized, double-masked, placebo-controlled pilot study (NCT07395986) is evaluating the efficacy and safety of ZOC2017217 among patients with age-related cataract.
- The participants: an estimated 40 patients (aged 50+)
- Full criteria here
- The setup: patients randomized 1:1 to self-administer either 0.4% ZOC2017217 or a placebo into both eyes (study and non-study eye), twice a day (BID)
- The study eye is the eye that meets the study’s eligibility criteria (see here for a refresh), and will be used for investigators’ efficacy analyses.
- The duration: 24 weeks
Any exceptions to this setup?
Just one: Patients who have previously undergone cataract surgery in their non-study eye—or whose non-study eye is determined to be unsuitable for treatment with the drop due to safety or another concern—will only administer the drop in their study eye.
Also worth noting: Patients who develop new or ongoing ocular adverse events (AEs) at the end of the study (Week 24) will be asked to return 14 days later for a safety follow-up evaluation.
Duly noted. So what are investigators measuring?
The primary outcomes will be measured from baseline as compared to Weeks 4, 12, and 24. Among them:
- Best-corrected distance visual acuity (BCDVA)
- Contrast sensitivity
- Visual function questionnaire (VFQ-25) scores
- Crystalline lens opacity
To note: BCDVA will also be measured from those same timepoints based on the number of patients who:
- Gain ≥5, ≥10, or ≥15 letters
- Lose ≥5, ≥10, or ≥15 letters
- Achieve BCDVA ≥ 0.3, 0.1, or 0.0 logarithm of the minimum angle of resolution (LogMAR; Snellen: 20/40, 20/25, or 20/20)
Any secondary outcomes?
Just two:
- Safety, AEs monitoring (ocular and non-ocular)
- Safety and clinically relevant changes (see here for details on this)
The timeframe for these: From the start of patients using the drop (at Visit 2 on Day 1) to the time they exit the study (after Visit 6 procedures and assessments).
- Important to keep in mind: Visit 6 will be conducted 2 weeks after the last dose is administered at Week 24.
Lastly, the critical question: When can we expect a data readout?
Clinical Trials is currently estimating the study’s primary completion—in which the last participant is examined or receives an intervention to collect final data for the primary endpoint—for March 2027, with the full study expected to conclude in May 2027.
As always, stay tuned!