Okogen, Inc., Announces Initiation of Phase IIb Clinical Trial for Pink Eye (Acute Infectious Conjunctivitis)

Corporate Reorganization and Re-Focused Strategy Propels Advancement

San Diego, CA – October 31, 2023 – Okogen, an ophthalmic biotechnology company, today announced the initiation of a Phase IIb clinical trial evaluating OKG-0303 for Acute Infectious Conjunctivitis (“Pink Eye”) to be conducted in India. Additionally, as part of the corporate reorganization, Bradford Conlan has been appointed Executive Chairman and Joshua Moriarty, Okogen’s CEO, has been named to the Board of Directors.

“Understanding the true market need is often something that can be overlooked in product development. The Okogen team has worked tirelessly to refocus the Company’s effort to develop a single product that can address all forms of Acute Infectious Conjunctivitis, both viral and bacterial, in line with how healthcare providers currently treat the disease,” said Mr. Conlan, Okogen’s Executive Chairman. “Being able to recognize the need to shift the focus of the company without abandoning the initial thesis is a testament to the creativity and passion this team brings. I am excited to join them on this journey towards bettering patient care.”

OKG-0303 is a first in class, fixed dose combination product to treat the underlying cause and the associated signs and symptoms of both the viral and bacterial forms of Acute Infectious Conjunctivitis. The efficacy of the anti-viral component, OKG-0301, was evaluated in the Phase II RUBY Trial in patients with adenoviral conjunctivitis, confirming efficacy in shutting down viral replication1,2. The additional components, both commercially available as stand-alone ophthalmic products with long and established safety profiles, will allow for treatment of bacterial infections and subside the symptoms that are often most bothersome to patients, namely conjunctival hyperemia and discharge.

“We are excited to have Brad’s guidance as we embark on this next stage of the company to bring this unique treatment to healthcare providers and their patients suffering from Pink Eye,” said Mr. Moriarty. “Up to 80% of conjunctivitis cases presenting to healthcare providers are infectious and the differential diagnosis is less than 50% accurate. OKG-0303 will bridge that gap in preventing the rapid spread of either etiology.”

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
Okogen is a clinical-stage, ophthalmic biotechnology company focused on developing innovative therapeutics to address unmet needs in ocular diseases. OKG-0502, the company’s lead development candidate, is a treatment for the associated signs and symptoms of adenoviral conjunctivitis. Okogen is US-based company, with a wholly owned Australian subsidiary Okogen Pty. Ltd. For more information about Okogen, visit www.okogen.com and follow us on LinkedIn

References

1. Romanowski et al., Ranpirnase (OKG-0301), a Novel Ribonuclease, Demonstrates Antiviral Activity against Adenovirus in the Ad5/NZW Rabbit Ocular Replication Model. Pathogens 2022,11,1485.

2. Watson et al. Acute Adenoviral Conjunctivitis Treatment: A Phase 2 Interim Analysis of OKG-0301. Presented at ARVO 2021 Virtual Meeting