The fusion protein is part of Ocugen’s portfolio of therapies for blindness diseases. Credit: Hryshchyshen Serhii / Shutterstock.
US-based biotechnology company Ocugen has received approval from the Data and Safety Monitoring Board (DSMB) to begin dosing the second cohort of patients in a Phase I trial of OCU200, a fusion protein for treating diabetic macular oedema (DME).
The decision comes after the DSMB completed a safety data review following first-cohort dosing in the study’s dose-escalation portion.
The open-label, dose-escalation trial aims to evaluate OCU200’s safety when given via intravitreal injection across three different doses.
It will involve three cohorts being given 0.025mg, 0.05mg and 0.1mg of the low, medium and high doses, respectively.
Each participant will be given two doses six weeks apart, with a follow-up period of up to six months.
Ocugen aims to complete the trial by the second half of this year and plans to release preliminary safety and efficacy data throughout the year.
Ocugen chief medical officer Dr Huma Qamar said: “It is encouraging that we have completed dosing in the low dose cohort for OCU200, a novel biologic that has a very favourable safety and tolerability profile.
“There remains a considerable unmet medical need for the 30% to 40% of DME patients who do not respond to current anti-VEGF therapies.
“OCU200 holds the promise of potentially benefitting all DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD) patients.”
According to Ocugen, nearly 130 million patients worldwide suffer from conditions such as DME, DR or wet AMD.
These conditions often result in symptoms such as blurred vision and progressive vision loss.
OCU200 consists of two human proteins, tumstatin and transferrin, joined by a linker.
The drug is part of Ocugen’s portfolio of therapies designed to treat blindness diseases.
In March 2024, the company finished dosing subjects in the first cohort of its Phase I/II ArMaDa trial for OCU410, a drug intended to treat geographic atrophy.
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