Phase 2 study of ABVC BioPharma Vitargus® receives ethical approval at Sydney Eye Hospital in Australia
Early clinical studies indicate that Vitargus® has unique properties that could eliminate the need for patients to remain face-down after retinal detachment and vitreous hemorrhage surgery.
Early clinical studies indicate that Vitargus® has unique properties that could eliminate the need for patients to remain face-down after retinal detachment and vitreous hemorrhage surgery. (Image Credit: Adobe Stock/Tung)
ABVC BioPharma, Inc. announced that the Vitrargus® Phase 2 study at the Sydney Eye Hospital in New South Wales, Australia received ethical approval from the St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC). This approval was determined on May 15, 2023.
Early clinical studies indicate that Vitargus® has unique properties that could eliminate the need for patients to remain face-down after retinal detachment and vitreous hemorrhage surgery, as well as significantly improve patient comfort and visual acuity during the surgical recovery period compared to currently available products. The objective of the Phase 2 study entitled “A Perspective Multi-Site Open-Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE)” is to demonstrate the safety and efficacy of Vitargus® for the treatment of uncomplicated retinal detachment when compared to the commonly used SF6 Gas OE. The Phase 2 study will enroll at least forty patients and will be conducted in both Australia and Thailand.
“We are extremely excited to receive the approval from St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) to conduct the Phase II study at Sydney Eye Hospital,” said Dr. Howard Doong, Chief Executive Officer of the Company. “Sydney Eye Hospital will begin to recruit patients shortly under the direction of Professor Matthew Simunovic, Director, Chair Research Committee, joining the three other clinical sites in Thailand and Australia.”
