Shenzhen Oculgen Biomedical Technology Co., Ltd. (Oculgen) recently announced that the first U.S. participant has been enrolled in the phase 2/3 STAT clinical trial evaluating OCUL101 in adults with treatment-naïve wet age-related macular degeneration (AMD).
Let’s start with Oculgen.
Headquartered in Shenzhen, China, the company was established in August 2022 by Chiung-Kuang Jack Chen, MD, a globally recognized expert in drug development for retinal diseases.
- The focus: Developing bispecific and multi-specific biologics for serious retinal diseases, covering all stages from early target discovery to commercialization.
And what has the company been up to recently?
In April 2025: Oculgen secured $20 million in Series A funding to support clinical research for OCUL101—and less than a year later, in February 2026, the company received clearance from the FDA to initiate a phase 2 trial (the topic of today’s discussion).
Then in March 2026: Oculgen announced the initiation of a global phase 2 program that includes:
- Three trials in China covering wet AMD, diabetic macular edema (DME), and geographic atrophy (GA)
- A parallel phase 2 trial in the United States
Noted. Now moving on to OCUL101.
OCUL101 is an investigational humanized, bi-specific antibody-like "trap" engineered to target angiogenesis and complement-driven inflammation by binding to vascular endothelial growth factor (VEGF)-A and complement component C5, respectively.
- Its indications: Wet AMD, DME, and GA
- Note: Only wet AMD is being evaluated in the U.S.
The drug is administered via intravitreal (IVT) injection and is being evaluated at two dose levels (6.5 mg / 50 µL and 10.4 mg / 80 µL) on dosing regimens designed to assess every-8-week or extended PRN intervals after a three-dose loading phase.
Talk about previous studies on OCUL101.
At the 2026 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, Dr. Chen presented phase 1b data from an ongoing phase 1b/2 trial for wet AMD in China evaluating the safety, tolerability, and efficacy of OCUL101.
The cohort: Patients with a medical history of multiple prior anti-VEGF intravitreal injections for wet AMD.
And what does the study’s design look like?
In three parts:
- Single ascending dose (SAD)
- Nine previously treated nAMD patients were enrolled across three cohorts (2.6, 6.5, 10.4 mg) and followed for 12 weeks
- Multiple ascending dose (MAD) mid-dose with an active aflibercept comparator (ongoing)
- Enrolled 12 anti-VEGF-treated subjects (6 OCUL101 6.5 mg; 6 aflibercept) receiving repeated injections through Day 144
- MAD high-dose (ongoing)
The findings?
OCUL101 produced dose-dependent BCVA gains (+2.7, +6.3, +9.0 letters at Day 85) and central retinal thickness (CRT) reductions (-36 μm, -44 μm, -96 μm), sustained through Week 12.
Moreover: A single high dose of OCUL101 demonstrated durability beyond 17 weeks, and repeated dosing resulted in enhanced visual superiority in best-corrected visual acuity (BCVA) and anatomical outcomes compared to aflibercept 2 mg (EYLEA).
And its safety profile?
The candidate demonstrated a favorable safety profile in both SAD and MAD studies, with no reported:
- Dose-limiting toxicities
- Serious adverse events
- Vision-threatening complications
By Day 85, the mid-dose cohort showed numerically greater BCVA improvement (+8.7 letters) at Day 85 versus aflibercept (+5.7 letters), with benefits increasing across doses.
With that out of the way, let’s circle back to this newer STAT trial.
STAT (STop ATrophy in AMD, NCT07520318) is a phase 2/3, multicenter, randomized, double-masked active comparator-controlled, parallel-group study.
Its purpose: to evaluate the safety, efficacy, durability, and pharmacokinetics of two doses of OCUL101 compared with aflibercept 2 mg in participants with neovascular AMD with or without GA.
- Per Clinical Trials: an estimated 255 patients are expected to be enrolled (participation criteria here).
And how is it set up?
The study is organized in two parts:
- Part A (open-label safety lead-in, n=5) evaluates the 10.4 mg high dose of OCUL101 IVT-administered every 4 weeks for three doses, followed by every 8 weeks through Week 36, then PRN through Week 96.
- Part B randomizes ~250 participants into four treatment arms evaluating two dose levels (6.5 mg and 10.4 mg) and multiple dosing regimens of OCUL101 compared with aflibercept 2 mg.
What are the main outcome measures?
The primary outcome measures include the incidence of treatment-emergent adverse events (TEAEs) and change from baseline in mean BCVA on the ETDRS chart at Week 36 compared with aflibercept 2 mg, assessed for non-inferiority at a 4.5-letter margin.
Secondary endpoints include:
- Central subfield macular thickness (CST) on spectral domain optical coherence tomography (SD-OCT)
- Proportion of participants gaining ≥15 Early Treatment Diabetic Retinopathy Scale (ETDRS) letters
- Change in choroidal neovascularization (CNV) lesion size vs. aflibercept at Week 96, measured via fluorescein angiography and color fundus photography
- Change in GA lesion size on fundus autofluorescence
Anything else?
Week 36 efficacy and safety data are intended to support a Biologics License Application (BLA); the study will continue to Week 96 for durability and longer-term safety assessment.
And when might we see results from this?
Per Clinical Trials, the study is expected to conclude in early 2029 … so a data readout is likely to be reported ahead of that.
As always, stay tuned for updates!