Opthea Limited announced the appointment of Julie Clark, MD, MS, as Senior Vice President (SVP), Clinical Development, and Fang Li, Ph.D. RAC, as SVP, Regulatory Affairs, effective February 1, 2024. Dr. Clark and Dr. Li will report to Opthea Chief Executive Officer, Frederic Guerard, PharmD, MS, and will join the Opthea Executive Management Team. With more than 15 years of experience in ophthalmology medical and clinical development, Dr. Clark brings expertise in both early and late-stage programs, regulatory submissions, and approvals.

Her contributions include substantial support for the approval and launches of retinal therapies such as EYLEA®, JETREA® and BEOVU®. In Dr. Clark?s most recent position as Vice President Clinical Development at IVERIC bio Inc., An Astellas Company, she oversaw the development program leading to the August 2023U.S. Food and Drug Administration (FDA) approval of IZERVAY?, a complement inhibitor approved for the treatment of geographic atrophy secondary to age-related macular degeneration. Dr. Clark previously served as Chief Medical Officer at Adverum Biotechnologies Inc, where she played a crucial role in developing intravitreal delivered gene therapy for retinal diseases.

Dr. Clark is a graduate of Wake Forest University and Wake Forest University School of Medicine in Winston-Salem, NC, U.S. Dr. Li brings over 30 years of expertise in drug development and more than 20 years in regulatory affairs experience. Her experience spans various domains including small molecules, biologics, gene therapy, over-the-counter products, in-vitro diagnostic products and medical devices, with a specific focus on ophthalmology. She has held key roles at prominent ophthalmology companies such as Novartis AG, Alcon Inc., and Bausch + Lomb Corporation.

Dr. Li's extensive background includes significant involvement in health authority interactions, U.S. FDA advisory committee meeting preparation and the establishment and leadership of regulatory teams. She has a proven track record of success in obtaining product approvals in the U.S. and other regions. Throughout her career, Dr. Li has played a pivotal role in leading numerous FDA drug approvals, specifically contributing to the approval of ophthalmology products like JETREA®, LOTEMAX® Ointment, SYSTANE® COMPLETE. She has also contributed to the development and registration of other ophthalmology drug products such as BEOVU®, PAZEO®, LOTEMAX® GEL, BESIVANCE®, and VYZULTA®.

Fang holds a PhD in Medicinal Chemistry from China Pharmaceutical University, China.