Phase III VELOS-3 trial of tanfanercept fails to meet primary endpoints in dry eye disease.- HanAll Biopharma
HanAll Biopharma announced results from the Phase III VELOS-3 trial evaluating the safety and efficacy of tanfanercept, a novel, topical anti-inflammatory treatment being studied for the treatment of dry eye disease (DED) in subjects diagnosed with moderate to severe DED.
The Phase III VELOS-3 trial did not demonstrate statistical significance for either of the two primary efficacy endpoints: improvement from baseline in central corneal staining score (CCSS) and in improvement from baseline in Eye Dryness Score via Visual Analogue Scale (VAS) assessed at week 8 in subjects with dry eye disease (DED), relative to vehicle.
However, VELOS-3 did demonstrate statistically significant improvement (p<0.001) in the secondary efficacy endpoint of unanesthesized schirmer testing to quantify change from baseline in tear volume in tanfanercept treatment arm relative to vehicle arm assessed at week 8. additionally, further analysis of schirmer data in velos-3 revealed that the proportion of subjects whose schirmer test improved from baseline by 10mm or greater as assessed at week 8 was statistically significant (p><0.001) in the tanfanercept treated arm (15%) relative to vehicle arm (4%).></0.001)></0.001)>
Correspondingly, in a post hoc analysis of VELOS-2 data (a previous phase III study), when the subset of subjects that met VELOS-3 inclusion criteria are examined, data from Schirmer testing also meets statistical significance (p<0.05) for improvement in subjects in the tanfanercept arm relative to subjects in vehicle control arm as assessed at week 8. overall, tanfanercept was well tolerated and the safety findings from velos-3 were consistent with those of the previous studies without any significant new adverse events observed. the study data will be shared at upcoming scientific meetings.></0.05)>
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