Ocugen doses first patient in phase 1 trial of OCU200 for treatment of diabetic macular edema

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Key Takeaways

OCU200 is a recombinant fusion protein targeting integrin receptors with anti-inflammatory and anti-VEGF properties, potentially transforming DME treatment.
The phase 1 trial is a multicenter, open-label, dose-escalation study assessing OCU200's safety via intravitreal injections in three dosage cohorts.
Ocugen aims for OCU200 to be a first-line therapy for DME, diabetic retinopathy, and wet AMD, benefiting patients unresponsive to current treatments.

The phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in 3 cohorts.

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Ocugen announced the first patient in its OCU200 phase 1 clinical trial for diabetic macular edema (DME) has been dosed.

The company describes OCU200 as a “recombinant fusion protein that consists of two parts connected by a linker.” In OCU200 tumstatin is the active component and acts as an anti-inflammatory anti-VEGF agent by binding to integrin receptors. Transferrin, the second of the two parts, targets the drug to the choroid and retina by binding transferrin receptors on endothelial cells.

Shankar Musunuri, PhD, MBA, chairman, CEO, and co-founder of Ocugen commented on the dosing in a press release from the company.

“OCU200 has the potential to change the treatment landscape for DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD) with its unique mechanism of action, binding the active component—tumstatin—to integrin receptors that play a crucial role in disease pathogenesis,” said Musunuri. “OCU200 holds the promise to benefit all DME patients, including the 30-40% of patients who do not respond to current anti-VEGF therapies.”

The phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in three cohorts: low dose (0.025 mg), medium dose (0.05 mg), and high dose (0.1 mg). Patients will receive two intravitreal injections of OCU200 six weeks apart, with follow-up six months after the last injection.

Ocugen stated it intends to pursue approval to use OCU200 as a first-line therapy for DME, diabetic retinopathy, and wet age-related macular degeneration.

References:

Ocugen, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of OCU200—a Novel Integrin-Targeting Biologic for Diabetic Macular Edema. Press Release. Published January 16, 2025. Accessed January 17, 2025. https://ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-first-patient-dosed-phase-1-clinical-trial