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CLINICAL TRIALS IN DME

Improving vision
in people with
Diabetic Macular Edema

“With diabetes on the rise around the world, a growing number of working-age people suffer from irreversible vision loss due to diabetic macular edema. Improving and protecting their vision is a critical goal for Opthea’s clinical development program in DME.”

Parisa Zamiri, MD, PhD
Chief Medical Officer
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Diabetic Macular Edema: A Leading Cause of Vision Loss in Working-Age Adults

DME is estimated to affect around 19 million people worldwide, and with the rise of diabetes, the prevalence is expected to increase to 29 million by 2045.

 

High blood sugar levels in diabetic patients damage the nerves and blood vessels in the macula. This area of the retina is responsible for sharp vision which is essential for everyday activities including driving, reading and working at a computer.

Hyperglycemia and inflammation associated with diabetic small vessel disease can lead to diabetic macular edema (DME). DME occurs when blood vessels in the retina swell and leak, leading to fluid accumulation in the retina.

 

Anti-VEGF-A therapies are the current standard of care for DME patients. There is an unmet need for early intervention to prevent irreversible damage in the retina, as well as improve visual outcomes for patients treated with anti-VEGF-A therapies alone, which may lead to suboptimal vision outcomes.

Sozinibercept in Phase 1b/2a: Encouraging Results

Sozinibercept’s potential to improve visual and anatomic outcomes in DME

A Phase 1b/2a clinical trial administered sozinibercept in combination with anti-VEGF-A (aflibercept) to 153 patients with central-involved DME who previously received standard of care anti-VEGF-A therapy.

 

The trial consisted of two parts:

PHASE 1B: Sozinibercept showed dose response in visual acuity mean gain at week 12

In this first-in-human, open-label, multicenter, dose escalating Phase 1b DME trial, nine patients received sozinibercept (0.3, 1, or 2 mg) in combination with aflibercept (2 mg) once every four weeks for twelve weeks. The primary endpoint was safety, and the secondary endpoints included mean change from baseline in best-corrected visual acuity (BCVA) and anatomical parameters, including central subfield thickness (CST).

Sozinibercept combination therapy was well tolerated with no dose-limiting toxicities.
The trial also demonstrated a dose-response relationship of increased gains in BCVA for ascending doses of sozinibercept, with the 2 mg sozinibercept combination arm demonstrating the highest BCVA gain. All sozinibercept doses demonstrated a meaningful CST reduction.
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PHASE 2A: Combination therapy showed visual and anatomic improvement at week 12

The 144-patient dose-expansion trial randomized patients 2:1 to either receive sozinibercept (2 mg) in combination with aflibercept (2 mg) or aflibercept (2 mg) monotherapy. DME patients with suboptimal response to prior multiple anti-VEGF-A doses, demonstrated visual and anatomic improvements at week 12 following sozinibercept combination therapy.

We are currently finalizing our Phase 3 clinical program to advance the development of sozinibercept in DME.

Our Science Based on Bold Innovation

Sozinibercept combination therapy has the potential to elevate standard-of-care by delivering superior vision outcomes.

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