Okogen Announces Regulatory Submission to CDSCO for EMERALD STUDY and Appointment of New Chief Medical Officer

Key Takeaways

  • David A. Hollander, MD, MBA, has been appointed as Okogen’s new Chief Medical Officer (CMO), bringing extensive experience in drug development and regulatory affairs to lead the company’s clinical and regulatory initiatives.
  • Okogen Inc. has submitted a regulatory application to the Central Drugs Standard Control Organization (CDSCO) in India for its Phase IIb clinical trial, The Emerald Study, which aims to evaluate the effectiveness of a triple-combination eyedrop for bacterial and viral conjunctivitis.
  • The Emerald Study, set to begin during the 2025 Monsoon Season in India, will provide valuable data for Okogen's AI platform and aims to address the growing challenge of acute infectious conjunctivitis with innovative treatment solutions.

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 Conjunctivitis
Pink 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.

Key Takeaways

  • David A. Hollander, MD, MBA, has been appointed as Okogen’s new Chief Medical Officer (CMO), bringing extensive experience in drug development and regulatory affairs to lead the company’s clinical and regulatory initiatives.
  • Okogen Inc. has submitted a regulatory application to the Central Drugs Standard Control Organization (CDSCO) in India for its Phase IIb clinical trial, The Emerald Study, which aims to evaluate the effectiveness of a triple-combination eyedrop for bacterial and viral conjunctivitis.
  • The Emerald Study, set to begin during the 2025 Monsoon Season in India, will provide valuable data for Okogen's AI platform and aims to address the growing challenge of acute infectious conjunctivitis with innovative treatment solutions.

Media Gallery

Quotes

“A combination of timing and innovative thinking related to addressing this unmet need puts Okogen at the forefront of potentially solving one of o...
David A Hollander, MD, MBACMO, Okogen Inc.
“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 ...
Joshua MoriartyChief Executive Officer

Related Bios

Joshua Moriarty
Chief Executive Officer
With 19 years in ophthalmic product development, Joshua Moriarty is the CEO & Director of Okogen and has led the company through a restructure and pivot towards the current focus of patient centric care technologies for Acute Infectious Conjunctivitis. Prior to Okogen, Mr. Moriarty held various positions at Ora, Inc., a leading ophthalmic clinical research and product development firm, most recently as Executive Director. He brings a broad skill set, having spent considerable time working alongside small to mid-size ophthalmic companies traversing the development process including strategic planning, fundraising, coordinating IND-enabling activities, and executing clinical and regulatory pathways.
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David A Hollander, MD, MBA
CMO, Okogen Inc.
David Hollander, MD, MBA is the Chief Medical Officer of Okogen, Inc. Dr. Hollander most recently also served as Chief Medical Officer and Global Therapeutics Commercial Lead at Revance Therapeutics, Inc, until its acquisition by Crown Laboratories in February 2025. Prior to Revance, Dr Hollander was the Chief Research and Development Officer of Aerie Pharmaceuticals, Inc. Dr. Hollander began his career in industry in 2006 at Allergan, Inc as a Medical Director of Ophthalmology where he also held a number of leadership roles including Vice President of Eye Care for U.S. Medical Affairs, Vice President and Head of Eye Care for Global Medical Affairs, as well as Therapeutic Area Head in Clinical Development for Anterior Segment and Consumer Eye Care. Dr. Hollander also serves as a Director for Kiora Pharmaceuticals (NASDAQ: KPRX).

During this time, Dr. Hollander continued to see patients and instruct residents and fellows in cataract surgery and corneal transplantation. Dr. Hollander previously also served as Chief Medical Officer of Ora, Inc, where he oversaw medical operations across pharmaceutical and device clinical development, preclinical studies, as well as research and development into new regulatory endpoints, most notably the development of novel mobility courses for evaluating treatments for inherited retinal diseases.

Dr. Hollander received his B.S. in chemistry with honors and distinction from Stanford University and earned his medical degree at the University of Pennsylvania School of Medicine. Dr. Hollander also obtained an M.B.A. in Health Care Management from the Wharton School at the University of Pennsylvania. Dr. Hollander completed his residency in ophthalmology at the University of California, San Francisco, and a Heed Fellowship in Cornea, External Disease and Refractive Surgery at the Jules Stein Eye Institute/University of California, Los Angeles.
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Contacts

Joshua Moriarty
Jmoriarty@okogen.com
Chief Executive Officer