VivaVision Biotech has reported positive topline data from a Phase II clinical trial of VVN001 in dry eye disease patients.
VVN001 is a potent and new second-generation inhibitor of lymphocyte function-associated antigen 1 (LFA-1).
The double-masked, randomised, vehicle-controlled trial analysed the safety and efficacy of the therapy in dry eye disease patients.
It enrolled 170 subjects at 14 study centres in the US. These subjects were categorised into three groups to receive VVN001 (5%), VVN001 (1%) or VVN001 vehicle twice a day for more than 84 days.
Findings showed that a treatment impact was observed in the prior primary efficacy endpoint of inferior corneal staining following dosing for 84 days.
Participants in the 1% and 5% treatment arms showed improvement as they did in the vehicle arm.
Furthermore, the improvement reported in the 5% treatment arm was greater than that observed in the vehicle.
A statistically and clinically significant improvement was seen in total corneal staining with dosage and treatment length-associated improvement compared to vehicle noted.
The company also reported comparable effects in the sign of clinically significant improvement in Schirmer scores.
A statistically and clinically significant improvement from baseline was seen in a priori selected symptom, SANDE scores, and a variation from the vehicle.
In addition, 1% and 5% of VVN001 demonstrated to be safe and well-tolerated without any substantial treatment-associated safety findings noted during the trial.
VivaVision Biotech chief medical officer Joanne Li said: “In this first-in-human study, we are very pleased to see that clinically relevant and statistically significant improvement over vehicle in both signs and symptoms was achieved for VVN001.
“We are also encouraged by the promising trends seen in the symptom endpoints. The results from this Phase II study will inform the design of future Phase III clinical studies.”