Okogen Submits Phase IIb Clinical Trial Application in India and Appoints New Chief Medical Officer
TL;DR
Okogen Inc. submits regulatory application for Phase IIb clinical trial in India, gaining first-mover advantage in conjunctivitis treatment market.
Emerald Study evaluates OKG-0303's components for bacterial and viral conjunctivitis, aligning with US FDA Guidance and training Okogen's AI platform for AIC.
Okogen's innovative eye care solutions aim to improve accurate diagnosis and treatment of infectious conjunctivitis, benefiting patient care and limiting spread in communities.
Dr. Hollander's appointment as CMO brings unique expertise to Okogen, pushing boundaries in ophthalmology with promising Phase IIb clinical trial and AI-enabled platform development.
Found this article helpful?
Share it with your network and spread the knowledge!
Okogen Inc., a company specializing in innovative eyecare solutions, announced the submission of a regulatory application to the Central Drugs Standard Control Organization in India for its Phase IIb clinical trial, The Emerald Study. The company also appointed David A Hollander, MD, MBA as its new Chief Medical Officer, who will play a crucial role in Okogen's clinical development and regulatory initiatives.
The Emerald Study will be conducted entirely in India during the 2025 Monsoon Season when rates of conjunctivitis significantly rise. The study aims 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. This research represents a significant advancement in addressing acute infectious conjunctivitis, which has long posed challenges for healthcare providers in delivering accurate diagnosis and effective treatment while limiting spread in school or work settings.
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. Joshua Moriarty, CEO of Okogen, stated that Dr. Hollander's appointment and the Emerald Study submission mark significant steps toward bringing Okogen's unique platform to market for managing patients suffering from acute infectious conjunctivitis.
The current conjunctivitis market is valued at $4.2 billion annually and is estimated to grow beyond $6.0 billion by 2031. Bacterial and viral conjunctivitis are easily spread from person to person if left untreated or improperly diagnosed, with no currently approved treatments for adenoviral conjunctivitis, which comprises over 90% of all viral ocular infections. The study will also provide an opportunity to collect data to further train Okogen's AI-enabled platform for evaluating acute infectious conjunctivitis, potentially revolutionizing diagnosis and treatment approaches for this widespread condition.
Curated from Reportable
