News

Article

Vantage Biosciences doses first patient in phase 2 study of VX-01, oral therapy for nonproliferative diabetic retinopathy

Key Takeaways

  • Vantage Biosciences has begun a phase 2 trial for VX-01, targeting moderate to severe NPDR without CI-DME.
  • The study is double masked, randomized, placebo controlled, and involves a 52-week treatment and 12-week observation period.
SHOW MORE

VX01-DR-201, is a phase 2, multicenter, double-masked, randomized, placebo-controlled study in patients with moderate to severe NPDR without center-involved diabetic macular edema (CI-DME).

A woman taking a round white pill (Image Credit: AdobeStock/Alex Photo)

(Image Credit: AdobeStock/Alex Photo)

Vantage Biosciences has successfully dosed the first patient in its phase 2 clinical study evaluating VX-01, an oral therapy for the treatment of nonproliferative diabetic retinopathy (NPDR).

VX01-DR-201, is a phase 2, multicenter, double-masked, randomized, placebo-controlled study designed to evaluate the efficacy of an oral dose of VX-01 in patients with moderate to severe NPDR without center-involved diabetic macular edema (CI-DME). Participants will be randomly assigned 1:1 into 1 of 2 study cohorts and will take VX-01 or placebo twice daily for 52 consecutive weeks, followed by a 12-week posttreatment observation period.

VX-01 is an orally administered small molecule therapy designed to target neurovascular inflammation associated with diabetic eye disease and aims to slow or prevent disease progression in patients with NPDR before irreversible vision loss occurs.

Alek Safarian, cofounder and chairman of Vantage Biosciences, commented on the trial in a press release from the company, saying, “We are pleased to initiate patient dosing in this important phase 2 study, which evaluates VX-01 as a potential early intervention for diabetic retinopathy. By targeting the disease at an earlier stage, VX-01 has the potential to slow or prevent progression to more severe forms of diabetic retinopathy, reducing the likelihood that patients will require invasive treatments in the future.”

The company stated that the study is expected to read out in 2027 and is being run at 27 sites across the US, Australia, and a number of Southeast Asian countries.

Reference
Vantage Biosciences doses first patient in phase 2 clinical study of oral VX-01 for nonproliferative diabetic retinopathy. News release. Vantage Biosciences. April 11, 2025. Accessed April 11, 2025. https://www.globenewswire.com/news-release/2025/04/11/3059941/0/en/Vantage-Biosciences-Doses-First-Patient-in-Phase-2-Clinical-Study-of-Oral-VX-01-for-Non-Proliferative-Diabetic-Retinopathy.html

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) Dilsher Dhoot, MD, on the evolution of geographic atrophy therapy: where are we now?
(Image credit: Ophthalmology Times Europe) Anat Loewenstein, MD, shares insights on the real-world results of remote retinal imaging
(Image credit: Ophthalmology Times) Two-wavelength autofluorescence for macular xanthophyll carotenoids with Christine Curcio, PhD
(Image credit: Ophthalmology Times) FLIO and the brain: Making the invisible visible with Robert Sergott, MD
(Image credit: Ophthalmology Times) Structure-function correlates using high-res OCT images with Karl Csaky, MD, PhD
(Image credit: Ophthalmology Times) SriniVas Sadda, MD, on high-res OCT of atrophic and precursor lesions in AMD
(Image credit: Ophthalmology Times) Christine Curcio, PhD, shares histology update supporting review software and revised nomenclature for <3 μm OCT
© 2025 MJH Life Sciences

All rights reserved.