Plano, TX – April 2, 2025 – Okogen Inc., a company specializing in innovative eyecare solutions, today announced the submission of a regulatory application to the Central Drugs Standard Control Organization (CDSCO) in India for its Phase IIb clinical trial, The Emerald Study. In conjunction with this regulatory milestone, Okogen is also pleased to announce the appointment of David A Hollander, MD, MBA as its new Chief Medical Officer (CMO). Dr. Hollander will serve a crucial role in Okogen’s clinical development and regulatory initiatives, further strengthening the company’s commitment to advancing innovative solutions for AIC.

The Emerald Study will be conducted entirely in India during the 2025 Monsoon Season when rates of conjunctivitis significantly rise. The goals of the study are to evaluate the individual contribution of each component of OKG-0303, a triple-combination eyedrop targeting both bacterial and viral conjunctivitis, in line with US FDA Guidance. The study will also provide a unique opportunity to collect data to further train Okogen’s AI enabled platform for the evaluation of AIC.

“Acute infectious conjunctivitis has long posed a challenge for healthcare providers to deliver an accurate diagnosis and effective treatment, while attempting to limit the spread to close contacts in the school or work setting,” said Dr. Hollander. “A combination of timing and innovative thinking related to addressing this unmet need puts Okogen at the forefront of potentially solving one of ophthalmology’s great challenges. I’m excited to be joining the team at this pivotal time as we embark on the commencement of the Emerald Study later this year and advance our technologies into the clinic.”

Dr. Hollander brings extensive experience in drug development and regulatory affairs, having recently served as Chief Medical Officer at Revance and overseen the approval and commercial launch of Daxxify into therapeutics. His previous leadership roles included serving as Chief R&D officer at Aerie Pharmaceuticals and Therapeutic Area Head for Anterior Segment at Allergan. Dr. Hollander earned his medical degree at the University of Pennsylvania School of Medicine and obtained an M.B.A. in Health Care Management from the Wharton School.  He completed his ophthalmology residency at the University of California, San Francisco, and a Heed Fellowship in Cornea and External Disease at the University of California, Los Angeles.  

“Dr. Hollander has a unique ability to bring together medical, clinical and commercial knowledge, who has been a colleague for over a decade, I am thrilled for the opportunity to have him join the Okogen team as we progress through this development program, and push back on conventional thought.” said Joshua Moriarty, CEO of Okogen. “Our submission of the Emerald Study to CDSCO is a significant step in executing our plan towards a data readout in Q4 and a testament to the hard work the team has put into this program. These milestones mark a significant step toward bringing Okogen’s unique platform to market for the management of patients suffering from acute infectious conjunctivitis, one of the world’s largest and most affected populations.”

About Acute Infectious ConjunctivitisPink eye (acute infectious conjunctivitis) is when the conjunctiva is irritated by a viral or bacterial infection. The current conjunctivitis market is USD $4.2 billion annually and is estimated to grow beyond USD $6.0 billion by 2031. Bacterial and viral conjunctivitis are easily spread from person to person if left untreated or properly diagnosed. There are currently no approved treatments for adenoviral conjunctivitis, comprising +90% of all viral ocular infections.
About Okogen, Inc.Okogen, Inc. is a cutting-edge eyecare product development company focused on delivering patient-centric solutions, with a current focus on acute infectious conjunctivitis. The company’s lead product, OKG-0303, is a triple-active combination eyedrop designed to treat both forms of acute infectious conjunctivitis, bacterial and viral, safely and effectively. In addition to advancing its Phase 2b clinical program, Okogen is developing an AI-powered evaluation tool aimed at improving patient care. The company is committed to innovation and expects a Phase 2b data readout by Q4 2025.
For more information, please visit www.okogen.com.

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