Okogen, Inc., a clinical-stage biotechnology company developing a host-directed antiviral platform, today announced that the first patient has been dosed in the EMERALD Trial, its multicenter Phase 1/2 clinical study evaluating Treyegen™ (OKG-0303) for acute infectious conjunctivitis. First dosing occurred at Ambade Eye Hospital in Nagpur, India.
The milestone advances Okogen’s lead program into clinical evaluation following authorization by India’s Central Drugs Standard Control Organisation (CDSCO). Treyegen combines ranpirnase, an investigational antiviral; tobramycin, a broad-spectrum antibacterial agent; and oxymetazoline, intended to reduce ocular congestion. EMERALD is designed to evaluate the safety and potential clinical efficacy of this investigational three-component approach to acute infectious conjunctivitis.
“Dosing the first patient in EMERALD represents an important milestone in Okogen’s development of Treyegen,” said Joshua Moriarty, Chief Executive Officer of Okogen. “We built Treyegen around a clear goal: to change how acute infectious conjunctivitis is treated. Physicians need a therapy designed for the uncertainty they face at the first visit, when the cause of infection is often unknown. EMERALD is our opportunity to test that approach and generate the evidence needed to move it forward.”
Acute infectious conjunctivitis can involve viral or bacterial pathogens often with overlapping clinical presentations. Physicians frequently must make treatment decisions before laboratory confirmation is available. Treyegen is being developed to address this challenge by bringing complementary antiviral, antibacterial and symptom-relieving mechanisms into a single investigational ophthalmic therapy. Currently, there are no FDA-approved antiviral therapies specifically indicated for adenoviral conjunctivitis, one of the most common causes of infectious conjunctivitis.
The program also represents a significant step for Okogen’s broader ranpirnase platform. The Company is advancing ophthalmology as its lead clinical application while pursuing development opportunities across four therapeutic pillars: ophthalmology, systemic infectious diseases, medical countermeasures and dermatology.
About the EMERALD Study
EMERALD is a multicenter Phase 1/2 clinical study in India evaluating Treyegen (OKG-0303) for acute infectious conjunctivitis. The program begins with an open-label Phase 1 evaluation of safety and tolerability, including systemic pharmacokinetic assessments. Following the required safety assessments and regulatory review, the program is designed to advance into a randomized, double-masked, vehicle-controlled Phase 2 evaluation of clinical efficacy and individual component contribution. Assessments include clinical outcomes and measures of viral and bacterial activity. The EMERALD program is expected to enroll more than 300 participants across multiple clinical sites in India.
About Treyegen™ (OKG-0303)
Treyegen is an investigational ophthalmic therapy being developed for acute infectious conjunctivitis. The proprietary formulation combines ranpirnase, a host-directed antiviral; tobramycin, a broad-spectrum antibacterial agent; and oxymetazoline, intended to reduce congestion in the eye. Its complementary mechanisms are designed to address the broad clinical presentation of acute infectious conjunctivitis. Treyegen has not been approved for commercial use.
