ABVC - American BriVision Highlights Results from Vitargus(R) First-in-Human Clinical Trial

·         Dr. Andrew Chang, principal investigator,recently presented encouraging feasibility study results from Vitargus® at theAAO 2019 Annual Meeting

·         Study results suggest Vitargus® is safe andwell-tolerated and may be a viable vitreous substitute to be used in vitrectomysurgeries

·         Company to initiate multi-national, multi-sitepivotal study for Vitargus® in 2020, assuming sufficient funding

Fremont, CA - (NewMediaWire) - October 15, 2019 - American BriVision (Holding) Corporation (OTCQB: ABVC)(the “Company”), a clinical stage biopharmaceutical company developingtherapeutic solutions in oncology/hematology, CNS, and ophthalmology, todayannounced encouraging results from the First-in-Human Clinical Trial(“feasibility study” or “study”) for Vitargus®, the Company’s investigationalmedical device. These results were first reported by Dr. Andrew Chang, theprincipal investigator of the feasibility study, on October 11, 2019, at theRetina Subspecialty Day program of the American Academy of Ophthalmology (AAO)2019 Annual Meeting. 

The feasibility study was aPhase I, single center safety and tolerability study of Vitargus® as a vitreoussubstitute for patients undergoing vitrectomy surgery for retinal detachment orvitreous hemorrhage, which involves the leakage of blood into the areas in andaround the vitreous humor of the eye. Such surgeries typically involve theremoval of either all or a portion of the compromised vitreous fluid andreplacement with a vitreous substitute. The currently available vitreoussubstitutes are a range of gases and liquids, but all have significantlimitations that affect clinical outcomes and patient quality of life. It isknown that the properties of the vitreous substitutes play a critical role insurgical outcomes. Grand View Research estimates the global retinal surgerydevices market size to be $1.56 billion in 2016, growing at a 7.8% CAGR through2025, and driven by the growing prevalence of diabetic retinopathy, a majorcomplication arising from diabetes. 

“We are quite excited andencouraged by these feasibility study results,” said Dr. Howard Doong, ChiefExecutive Officer of the Company. “To our knowledge, we are the first group tosuccessfully complete the Phase I study for a vitreous body substitute in ahuman. We also believe that the physical properties of Vitargus® could offerclinical advantages that would help surgical outcomes and minimize the need forrepeated vitrectomy surgeries, benefiting thousands of patients worldwide. Ofcourse, we look forward to conducting the considerably larger pivotal trialwith over 300 patients across numerous sites and numerous countries andanticipate this trial to start in early 2020.”

Patient enrollment in thefeasibility study occurred between January 2017 – January 2018, and the finalpatient data was collected in July 2018. A total of 13 patients were screenedfor the trial, and 10 patients successfully completed the study. The primaryobjective of the study was to evaluate the safety and tolerability of a singleVitargus® dose as a vitreous substitute during vitrectomy surgery. Secondaryobjectives included the assessment of retinal attachment and Best CorrectedVisual Acuity (BCVA) after surgery. 

In the study, no apparenttoxicity or serious adverse events (SAEs) directly caused by Vitargus® wereobserved, and Vitargus® was well-tolerated and an effective vitreoussubstitute. A total of six SAEs were recorded from three patients, though nonewere deemed related to Vitargus®, according to the study’s independent datasafety monitoring board.

Moreover, an exploratoryanalysis of the secondary endpoints showed a statistically significantimprovement from baseline in BCVA at several time points, including the finalvisit. Overall, the results demonstrating vision improvement and retinalre-attachment indicate Vitargus® may be a viable potential alternative forvitreous substitution in the surgical treatment of retinal detachment andvitreous hemorrhage. Accordingly, the Company plans to initiate a multi-national,multi-site pivotal study for Vitargus® in 2020, assuming the Company hasadequate funding for the trial. 

About American BriVision

American BriVision is a clinical stagebiopharmaceutical company focused on utilizing its licensed technology toconduct proof-of-concept trials through Phase II of the clinical developmentprocess at world-famous research institutions (such as Stanford University,University of California at San Francisco, and Cedars-Sinai Medical Center).The company has an active pipeline of six drugs and one medical device(ABV-1701/Vitargus®) under development.

Forward-Looking Statements

Clinical trials are in early stages and thereis no guarantee that any specific outcome will be achieved. This press releasecontains “forward-looking statements.” Such statements may be preceded by thewords “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,”“predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similarwords. Forward-looking statements are not guarantees of future performance, arebased on certain assumptions, and are subject to various known and unknownrisks and uncertainties, many of which are beyond the Company’s control, andcannot be predicted or quantified, and, consequently, actual results may differmaterially from those expressed or implied by such forward-looking statements.Such risks and uncertainties include, without limitation, risks anduncertainties associated with (i) our inability to manufacture our productcandidates on a commercial scale on our own, or in collaboration with thirdparties; (ii) difficulties in obtaining financing on commercially reasonableterms; (iii) changes in the size and nature of our competition; (iv) loss ofone or more key executives or scientists; and (v) difficulties in securingregulatory approval to proceed to the next level of the clinical trials or to marketour product candidates. More detailed information about the Company and therisk factors that may affect the realization of forward-looking statements isset forth in the Company’s filings with the Securities and Exchange Commission(SEC), including the Company’s Annual Report on Form 10-K and its QuarterlyReports on Form 10-Q. Investors are urged to read these documents free ofcharge on the SEC’s website at http://www.sec.gov. TheCompany assumes no obligation to publicly update or revise its forward-lookingstatements as a result of new information, future events or otherwise.

Contact:

Andy An – Chief Financial Officer

765-610-8826

andyan@ambrivis.com