American BriVision (Holding) Corporation (OTCQB: ABVC) (the “Company”), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced encouraging results from the First-in-Human Clinical Trial (“feasibility study” or “study”) for Vitargus®, the Company’s investigational medical device. These results were first reported by Dr. Andrew Chang, the principal investigator of the feasibility study, on October 11, 2019, at the Retina Subspecialty Day program of the American Academy of Ophthalmology (AAO) 2019 Annual Meeting.
The feasibility study was a Phase I, single center safety and tolerability study of Vitargus® as a vitreous substitute for patients undergoing vitrectomy surgery for retinal detachment or vitreous hemorrhage, which involves the leakage of blood into the areas in and around the vitreous humor of the eye. Such surgeries typically involve the removal of either all or a portion of the compromised vitreous fluid and replacement with a vitreous substitute. The currently available vitreous substitutes are a range of gases and liquids, but all have significant limitations that affect clinical outcomes and patient quality of life. It is known that the properties of the vitreous substitutes play a critical role in surgical outcomes. Grand View Research estimates the global retinal surgery devices market size to be $1.56 billion in 2016, growing at a 7.8% CAGR through 2025, and driven by the growing prevalence of diabetic retinopathy, a major complication arising from diabetes.
“We are quite excited and encouraged by these feasibility study results,” said Dr. Howard Doong, Chief Executive Officer of the Company. “To our knowledge, we are the first group to successfully complete the Phase I study for a vitreous body substitute in a human. We also believe that the physical properties of Vitargus® could offer clinical advantages that would help surgical outcomes and minimize the need for repeated vitrectomy surgeries, benefiting thousands of patients worldwide. Of course, we look forward to conducting the considerably larger pivotal trial with over 300 patients across numerous sites and numerous countries and anticipate this trial to start in early 2020.”
Patient enrollment in the feasibility study occurred between January 2017 – January 2018, and the final patient data was collected in July 2018. A total of 13 patients were screened for the trial, and 10 patients successfully completed the study. The primary objective of the study was to evaluate the safety and tolerability of a single Vitargus® dose as a vitreous substitute during vitrectomy surgery. Secondary objectives included the assessment of retinal attachment and Best Corrected Visual Acuity (BCVA) after surgery.
In the study, no apparent toxicity or serious adverse events (SAEs) directly caused by Vitargus were observed, and Vitargus was well-tolerated and an effective vitreous substitute. A total of six SAEs were recorded from three patients, though none were deemed related to Vitargus, according to the study’s independent data safety monitoring board.
Moreover, an exploratory analysis of the secondary endpoints showed a statistically significant improvement from baseline in BCVA at several time points, including the final visit. Overall, the results demonstrating vision improvement and retinal re-attachment indicate Vitargus® may be a viable potential alternative for vitreous substitution in the surgical treatment of retinal detachment and vitreous hemorrhage. Accordingly, the Company plans to initiate a multi-national, multi-site pivotal study for Vitargus® in 2020, assuming the Company has adequate funding for the trial.
Source: Company Press Release
