Study failure of diabetic retinopathy eye drop leaves OcuTerra in tears

2024-03-15

OcuTerra Therapeutics on Thursday announced that its topical diabetic retinopathy candidate nesvategrast – the only asset in its pipeline – failed to meet the primary and key secondary efficacy endpoints of a Phase II study.

“We are disappointed that the top-line data…did not demonstrate a statistically significant impact on severity or progression of diabetic retinopathy,” remarked OcuTerra CEO Kerrie Brady. She added that the company would review the trial’s complete dataset to decide on the next steps for the small-molecule RGD integrin inhibitor, also known as OTT166, and explore strategic alternatives.

The DR:EAM study investigated daily nesvategrast across two dose levels against placebo in 225 patients with diabetic retinopathy. While the top-line data demonstrated favourable safety and tolerability for nesvategrast, it failed to show a significant improvement on the Diabetic Retinopathy Severity Scale (DRSS) versus placebo, which was the primary efficacy endpoint. The drug also fell short on the secondary goal of disease progression, but managed to meet the other secondary endpoint of preventing vision threatening events by week 24 in patients with baseline DRSS levels between 47 and 53.

Another topical small molecule vying for a spot in the diabetic retinal diseases space is Exonate’s SRPK1 inhibitor EXN-407, which recently showed favourable safety, tolerability and biological activity in a Phase Ib/IIa trial, making its way to the Phase IIb CLEAR-DM study.

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