Benzinga | Aug 26, 2021 08:36AM EDT

ABVC BioPharma Offers 3 Updates On Vitargus

ABVC BioPharma, Inc. (NASDAQ:ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today provided an update regarding recent developments in connection with Vitargus(r), the world's first bio-degradable vitreous substitute intended to facilitate retina re-attachment surgery. Early clinical studies indicate that Vitargus(r) has unique properties that result in eliminating the need for post-surgery patient face-down positioning, as well as significantly greater recovery period patient comfort and visual acuity than currently available products.

These developments include:

* ABVC has selected the first clinical study site and principal investigator for conducting a Phase II clinical study of Vitargus(r) in Australia. The objective of the study "A Prospective Multi-Site Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV1701 Ocular Endotamponade (OE)" is to demonstrate the safety and effectiveness of Vitargus(r) when compared to the commonly used SF6 Gas OE. Approval of the study by the Australian Therapeutic Goods Administration is expected in Q4 of 2021 with first patient enrollments beginning during Q1 of 2022.

* As previously disclosed, ABVC held a meeting with the US FDA on May 20, 2021, to review FDA comments regarding the results of the Vitargus(r) Phase I studies. The FDA requested additional data, primarily involving animal studies, which the company expects to provide early in 2022. ABVC was encouraged by the FDA discussion and strongly believes that the efficacy and safety of Vitargus(r) will be confirmed by the requested studies.

* The company continues to have active discussions with several large pharmaceutical companies interested in becoming distribution and/or manufacturing partners for Vitargus(r).

"We are encouraged by the progress we continue to make towards the multi-nation, multi-site pivotal Phase III clinical studies, which are an important step to ultimately receiving PMA market approval for Vitargus(r)," said Dr. Howard Doong, Chief Executive Officer of the Company. Dr. Doong further noted that "According to iHealthcareAnalyst, Inc., the global market for retinal surgery devices is expected to reach $3.7 billion by 2027 driven by a rising geriatric population worldwide."