• Therapeutic Cataract & Refractive
  • Lens Technology
  • Glasses
  • Ptosis
  • Comprehensive Eye Exams
  • AMD
  • COVID-19
  • DME
  • Ocular Surface Disease
  • Optic Relief
  • Geographic Atrophy
  • Cornea
  • Conjunctivitis
  • Myopia
  • Presbyopia
  • Allergy
  • Nutrition
  • Pediatrics
  • Retina
  • Cataract
  • Contact Lenses
  • Lid and Lash
  • Dry Eye
  • Glaucoma
  • Refractive Surgery
  • Comanagement
  • Blepharitis
  • OCT
  • Patient Care
  • Diabetic Eye Disease
  • Technology

Phase 2 trial for DME treatment fails to meet primary endpoints


Oxurion NV finds insufficient evidence of efficacy on key clinical endpoints for THR-687 in Part A of the INTEGRAL phase 2 trial; focus will now turn to an alternative candidate and trial.

Phase 2 trial for DME treatment fails to meet primary endpoints

Oxurion NV announced top-line results from Part A of its phase 2 trial for THR-687 to treat diabetic macular edema (DME).

Part A data of the INTEGRAL trial found THR-687, an integrin antagonist, to be safe and well-tolerated with no serious adverse effects, according to a news release. Additionally, none of the trial’s participants required rescue medication through Month 3.

However, there was no evidence that was sufficient enough to determine efficacy on the key endpoints: best-corrected visual acuity (BCVA) and central subfield thickness (CST).

Due to these insufficient findings, Oxurion has determined to not advance to Part B of the INTEGRAL trial.

Following this decision, the company will turn its focus to THR-149, which recently indicated a compelling safety and efficacy profile in patients with DME in the first part of the 2-part, phase 2 KALAHARI trial.

INTEGRAL trial background
As a 2-part, randomized, prospective, multicenter trial, INTEGRAL sought to analyze multiple injections of THR-687 in treatment naïve patients diagnosed with DME. Endpoints from Part 1 included safety (n = 16) and efficacy (n = 14), according to the company.

Two doses levels of THR-687 (1.2 mg and 2.0 mg) were each administered in 3 monthly intravitreal injections. Participants are being followed through Month 6 for Part A of the trial.

Related Videos
Deborah Ferrington details a session on mitochondrial maintenance and retinal health in patients with AMD at ARVO 2024
Dr. John Sheppard discusses results from trials testing the efficacy of eye drops to treat dry eye disease
Danica Marrelli, OD, FAAO, AAO Dipl, co-chair of EnVision Summit chats about geographic atrophy and glaucoma panels
Steven Ferrucci, OD, FAAO - AAOpt
Janis Winters, OD, FAAO
Justin Schweitzer and Nate Lighthizer discuss surgical interventions in glaucoma at AOA 2023.
© 2024 MJH Life Sciences

All rights reserved.