ranpirnase ophthalmic (OKG-0301) / Okogen - LARVOL DELTA

Ranpirnase (OKG-0301), a Novel Ribonuclease, Demonstrates Antiviral Activity against Adenovirus in the Ad5/NZW Rabbit Ocular Replication Model. (PubMed, Pathogens) - "A day later, topical therapy was initiated in both eyes with 0.03% OKG-0301, 0.003% OKG-0301, saline or 0.5% cidofovir. Ranpirnase (OKG-0301) may be a potential candidate for a topical antiviral for adenoviral eye infections. Further clinical development is warranted."

Journal • Preclinical • Corneal Abrasion • Infectious Disease • Ocular Infections • Ophthalmology

RUBY: OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis (clinicaltrials.gov) - P2 | N=219 | Active, not recruiting | Sponsor: Okogen | Trial completion date: Jun 2021 ➔ Jun 2022 | Trial primary completion date: Jun 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology

[VIRTUAL] Acute Adenoviral Conjunctivitis Treatment: A Phase 2 Interim Analysis of OKG-0301 (ARVO 2021) - "OKG-0301 is a safe and effective antiviral for the treatment of acute adenoviral conjunctivitis. Its main biological activity appears to be limited to acceleration of viral eradication, with no observed effect on redness and discharge. Further formulation and additional clinical evaluation is warranted to develop OKG-0301 as the first approved treatment of acute adenoviral conjunctivitis."

P2 data • Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology

RUBY: OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis (clinicaltrials.gov) - P2; N=219; Active, not recruiting; Sponsor: Okogen; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ Jun 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Conjunctivitis • Ocular Inflammation • Ophthalmology

RUBY: OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis (clinicaltrials.gov) - P2; N=219; Recruiting; Sponsor: Okogen; Trial completion date: Oct 2019 ➔ Dec 2020; Trial primary completion date: Sep 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Royal Victorian Eye and Ear Hospital seeking patients for trial into world-first treatment (Mirage News) - "Okogen...announced that The Royal Victorian Eye and Ear Hospital is actively seeking patients for a clinical study into viral conjunctivitis, the #1 cause of eye infections globally. The Phase II clinical study...will evaluate the safety and efficacy of...OKG-0301, in the treatment of the highly contagious adenoviral conjunctivitis....The Royal Victorian Eye and Ear Hospital in partnership with the Centre for Eye Research Australia (CERA) is one of seven trial sites involved in RUBY, and expects strong enrolment given the already high rates of viral infections already this winter."

Trial status

Lion’s Eye Institute seeks world first treatment for common early childhood ailment (The Sector) - "The RUBY Trial is testing whether the drug OKG-0301 – an eye drop form of ranpirnase – is safe and helps people with viral conjunctivitis. The LEI is one of several Australian trials centres hoping to recruit people within the first three days of exhibiting conjunctivitis symptoms in order to test the new treatment....'The purpose of this research is to test whether this drug can reduce the length of time patients are infectious, as well as reducing the signs of symptoms like eye redness and eye discharge.'"

Enrollment status • Trial status

Eye Clinic Albury Wodonga seeking patients for trial into world-first treatment of viral conjunctivitis (Mirage News) - "Okogen...announced that Eye Clinic Albury Wodonga is actively seeking more patients for a clinical study of viral conjunctivitis....The Phase II clinical study, known as the RUBY Trial, will evaluate the safety and efficacy of Okogen’s lead candidate, OKG-0301, in the treatment of the highly contagious adenoviral conjunctivitis....Eye Clinic Albury Wodonga is one of seven trial sites participating in RUBY...."

Trial status

RUBY: OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis (clinicaltrials.gov) - P2; N=219; Recruiting; Sponsor: Okogen

Clinical • New P2 trial

Phase update (PRWeb) - P1➔P2, Ocular Infections

Phase shift

Okogen initiates phase 2 clinical trial (RUBY) of OKG-0301 in patients with acute adenoviral conjunctivitis (PRWeb) - "Okogen...announced the initiation of a Phase 2 clinical trial (RUBY) that is designed to evaluate the safety and efficacy of OKG-0301 in the treatment of acute adenoviral conjunctivitis....We are excited to initiate this Phase 2 trial and expect to complete enrollment by the end of 2019."

Trial status