Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

OcuTerra’s Phase II diabetic retinopathy trial misses endpoints

OcuTerra Therapeutics reported that its Phase II DREAM trial of nesvategrast (OTT166) eye drops for diabetic retinopathy (DR) didn't meet endpoints. The study aimed to evaluate the safety and efficacy of nesvategrast in high and low doses versus placebo over 24 weeks, involving 225 adults with moderate to severe non-proliferative DR (NPDR) or mild proliferative DR (PDR).

Primary efficacy was measured by the percentage of achieving a two-step or greater improvement on the DR Severity Scale (DRSS). Additional objectives included assessing the prevention of progression to vision-threatening events and delay in needing intravitreal injections or laser treatment.

Nesvategrast was safe and well-tolerated, meeting its primary safety endpoint, but didn't show significant improvement in DRSS scores or disease progression compared to placebo. However, a sub-analysis revealed a significant benefit in preventing vision-threatening events by week 24 in patients with moderately severe to severe NPDR at baseline.