Article

Oxurion NV doses first patient in study of THR-687 as DME treatment

Oxurion NV announced Wednesday the first patient to be dosed in the INTEGRAL phase 2 clinical study evaluating THR-687 as a treatment for patients with DME.

Oxurion NV announced Wednesday the first patient to be dosed in the INTEGRAL phase 2 clinical study evaluating THR-687 as a treatment for patients with DME.

Oxurion NV announced Wednesday the first patient to be dosed in the INTEGRAL phase 2 clinical study evaluating THR-687 as a treatment for patients with diabetic macular edema (DME).

The INTEGRAL study is a randomized, multicenter trial that is the first in which multiple intravitreal injections of THR-687 will be administered in humans, according to a company news release.

INTEGRAL intends to evaluate two parts: two dose levels of THR-687 injections (Part A), and if a success, then assess the efficacy and safety of THR-687 in comparison to aflibercept, for the treatment of DME (Part B).

The company reports that Part A of the study is being conducted in treatment naïve subjects to select the optimal THR-687 dose level to be assessed in Part B.

Part B will be conducted in both treatment naïve and treatment experienced subjects to evaluate the efficacy and safety of THR-687 compared to aflibercept, according to the news release.

The company reports that Part B’s primary efficacy endpoint is the changing in best-corrected visual acuity (BCVA) from baseline to Month 3.

Dose selection decision after Part A is estimated for the first half of 2022, while topline data from Part B to follow in the second half of 2023.

The latest development comes following the positive data from a phase 1, open-label, multi-center, single-dose escalation study assessing safety of THR-687 for DME in the form of a single intravitreal injection of 3 dose levels: 0.4 mg, 1.0 mg, and 2.5 mg.

Results from this study showed THR-687 was safe and well-tolerated.

In addition to DME, THR-687 shows potential as a treatment for wet age-related macular degeneration (AMD) and retinal vein occlusion (RVO).

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.