Luke Zack

Luke Zack, PharmD, is the Senior Director and Global Head of Regulatory Affairs Strategy at Oculis US, Inc., a global biopharmaceutical company pioneering innovative treatments for ophthalmic and neuro-ophthalmic diseases. In this role, Luke leads the development and execution of global regulatory strategies across Oculis’s diverse pipeline.
With nearly a decade of experience spanning regulatory strategy, regulatory intelligence, and global Health Authority engagement, Luke has successfully guided numerous programs from early development through approval across multiple therapeutic areas, including ophthalmology. His expertise encompasses the full spectrum of global regulatory submissions—INDs, CTAs, NDAs, BLAs, MAAs, and post-approval filings—driven by a commitment to advancing timelines without compromising scientific or regulatory excellence.
Before joining Oculis, Luke served as Head of Regulatory Strategy at Iveric Bio (acquired by Astellas in 2023), where he led the avacincaptad pegol (Izervay) program for Geographic Atrophy. He played a pivotal role in crafting the regulatory strategy that secured Breakthrough Therapy Designation and priority review for the program.
Luke earned his Doctor of Pharmacy (PharmD) degree from Wilkes University’s Nesbitt School of Pharmacy.