- VIS-101, purpose-designed to be best-in-class for retinal vascular diseases, is a tetravalent, dual VEGF-A X ANG-2 inhibitor
- Topline Phase 2a data show VIS-101 provides rapid, robust and durable treatment responses in wet AMD
- VIS-101 demonstrated mean BVCA improvements of >10 ETDRS letters and median CST reductions of 100-150 mm
- Potentially best-in-class durability with a favorable safety profile and no dose-limiting toxicity
- Phase 2b dose-determining study expected to begin in H2 2026; global Phase 3 program expected to begin in 2027
SHANGHAI, March 13, 2026 /PRNewswire/ — Everest Medicines (HKEX: 1952.HK) today announced that its licensing partner, NovaBridge Biopharma (NASDAQ: NBP, “NovaBridge”), together with its subsidiary Visara, Inc. (“Visara”), reported positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Topline results show that VIS-101 produced rapid, robust and durable treatment responses in wet AMD, with potential best-in-class durability and a favorable safety profile. Wet AMD affects more than 20 million people globally[1].
Topline Data:
VIS-101 produced rapid and robust efficacy, and durable treatment responses with both 3 mg and 6 mg dose cohorts:
- Mean improvement in Best Corrected Visual Acuity (BCVA) of >10 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters
- Median central subfield thickness (CST) reduction of 100-150 mm
- Potential best-in-class durability with:
- ~two thirds of patients retreatment-free at 4 months
- ~half of patients retreatment-free at 6 months
- Favorable safety and no dose limited toxicity
“We congratulate our partner on the positive top-line results from the VIS-101 Phase 2a study, marking an important milestone in its clinical development. Dual VEGF-A/ANG-2 inhibition has been validated as a key approach for treating retinal vascular disease, and extending treatment durability remains a critical unmet need,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “VIS-101 has demonstrated potentially best-in-class durability, robust visual and anatomic improvements, along with a favorable safety profile, providing a strong foundation for advancing its future clinical development. With Everest’s experience in clinical development and commercialization, we look forward to bringing VIS‑101, a highly differentiated bifunctional antibody with strong commercial potential, to patients across China and Asia in the near future.”
“I am encouraged by the positive Phase 2a safety and efficacy data as it provides important proof-of-concept for VIS-101 as a potential treatment for wet AMD. The data validates VIS-101’s purpose-engineered design and gives us added confidence in its potential to deliver best-in-class durability while maximizing visual gains in the treatment of wet AMD,” said Emmett T. Cunningham, Jr., MD, PhD, MPH, Founder and Executive Chairman of Visara and Vice-Chairman of the NovaBridge Board of Directors. “The data clearly show that VIS-101 produced rapid, robust and durable treatment responses, with favorable tolerability, after three loading doses. Importantly, VIS-101 also demonstrated potential best-in-class durability, with nearly half of treatment naïve patients remaining retreatment free for more than six months following induction. Such strong clinical results provide a meaningful foundation to advance our development program, including plans to initiate a dose-determining Phase 2b study in the second half of this year, followed by a global Phase 3 program in 2027.”
On October 30, 2025, Everest Medicines entered into a collaboration agreement with Visara, under which Everest acquired an exclusive license to develop, manufacture, and commercialize VIS-101 in Greater China, Singapore, South Korea, and certain Southeast Asian countries.
About the Randomized Phase 2a Study of VIS-101 in Wet AMD
Patient Characteristics:
The study enrolled 38 patients in China, aged 50-80 years of age with wet AMD (both treatment naïve and pre-treated). Patients were randomized 2:1 between 6mg dose (n=25) and 3 mg (n=13). Baseline characteristics were similar between both dose groups (noting a slightly higher proportion of pre-treated patients in the 6 mg dosing group).
Baseline Patient Demographics: Similar between dosing groups
|
Topline Phase 2a Data |
|||
|
Dose level |
6 mg (n=25) |
3 mg (n=13) |
Total (n=38) |
|
Patients |
|||
|
Age (years of age) |
|||
|
• Average |
69.5 |
71.5 |
|
|
Gender (%) |
|||
|
• Male/Female |
68%/32% |
61.5%/38.5% |
65.8%/34.2% |
|
Mean Baseline BCVA (Letters) |
54.7 |
52.3 |
53.9 |
|
Median Baseline CST (mm) |
417.2 |
407.6 |
413.9 |
|
Prior Anti-VEGF Therapy (%) |
|||
|
•Yes/No |
52%/48% |
30.8%/69.2% |
44.7%/55.3% |
Safety: VIS-101 Demonstrated a Favorable Safety Profile With No Dose-Limiting Toxicity
- The total treatment-related treatment emergent adverse events (TEAEs) were 0% (n=0) in the 3 mg dose and 8% (n=2) in the 6 mg dose, with 1 event each in two separate patients.
About the Randomized Phase 2a Study of VIS-101 in Wet AMD
The Phase 2a randomized study (NCT05456828) evaluated the safety and efficacy of VIS-101 (aka AM712 or ASKG712) in patients with wet AMD, including patients who were naïve to treatment or VEGF-experienced. The study enrolled a total of 38 wet AMD patients in China.
Patients were randomized 2:1 to 6mg VIS-101 (n=25) or 3 mg VIS-101 (n=13). The primary endpoint was safety and pharmacokinetics and the secondary endpoint was efficacy, measured by best corrected visual acuity (BCVA) change from baseline (assessed by early treatment diabetic retinopathy scale (ETDRS Letters), change in central subfield thickness (CST, measured in mm), and retreatment rate. Subjects were given three loading doses at weeks 0, 4 and 8, with monthly follow-up to week 36 or retreatment (based on protocol-defined Disease Activity Criteria based on BCVA, CST and wet AMD activity). Safety and efficacy endpoints were assessed at each visit including 24 weeks (6 months) after the last loading dose.
About VIS-101
VIS-101 (also known as ASKG712 or AM712), purpose-designed to be best-in-class, is a dual VEGF-A X ANG-2 inhibitor in development for the treatment of retinal vascular diseases, such as wet AMD, diabetic macular edema (DME) and retinal vein occlusion (RVO), which affect more than 57 million people globally[1]. VIS-101’s bispecific, tetravalent design format provides more binding sites and increased VEGF-A and ANG-2 affinity, for rapid, robust and class-leading durable responses. VIS-101 has completed initial safety and dose-escalation studies in both the US and China and a randomized, dose-ranging 2a study in China (NCT05456828). VIS-101 is expected to advance to a dose-determining Phase 2b study in 2026, with initiation of the global Phase 3 program in 2027.
Source information:
- Invest Ophthalmol Vis Sci. 2021 Nov 24; 62 (14): 26. doi: 10.1167/iovs.62.14.26
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies.
The Company’s therapeutic areas of focus include CKM (cardiovascular, kidney, and metabolic), autoimmune, ophthalmology and critical care. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company’s website: www.everestmedicines.com.
About Visara, Inc.
Visara is a clinical-stage biopharmaceutical company focusing on the development of best-in-class ophthalmic therapeutics. The Company is led by Co-Founder and Executive Chairman Emmett T. Cunningham, Jr., MD, PhD, MPH, a physician, innovator, entrepreneur, and investor and internationally recognized specialist in infectious and inflammatory eye disease, and Chief Medical Officer Cadmus Rich, MD, MBA, a serial entrepreneur and seasoned ophthalmic drug developer. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.
About NovaBridge
NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. The Company combines deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need.
The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, Claudin 18.2 X 4-1BB bispecific antibody, and VIS-101, purpose-designed to be a best-in-class dual VEGF-A X ANG-2 inhibitor.
Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The product candidate is being evaluated in a global, randomized Phase 2 study, following the recent announcement of positive topline results from a Phase 1b, multi-center, open label study in first line gastric cancer. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer.
VIS-101 targets VEGF-A and ANG-2 to provide more rapid, robust and durable treatment responses for patients with retinal vascular diseases including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. VIS-101 has completed a randomized, dose-ranging Phase 2a study for wet AMD and expects to initiate a Phase 2b study in H2 2026. NovaBridge is the majority shareholder of Visara, Inc., and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.
For more information, please visit www.novabridge.com and follow us on LinkedIn.
Forward Looking Statements
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
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