Tanfanercept fails to meet primary endpoints in phase 3 dry eye trial
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Key takeaways:
- Tanfanercept did not meet the primary efficacy endpoints in a phase 3 trial.
- A secondary outcome measure involving Schirmer testing of tear volume was achieved.
Tanfanercept did not demonstrate statistical significance in improvement in central corneal staining score or eye dryness score at week 8, the primary outcome measures of the phase 3 VELOS-3 trial, according to HanAll Biopharma.
The multicenter, randomized, double-masked vehicle-controlled study was designed to investigate the safety and efficacy of tanfanercept 0.25%, a topical anti-inflammatory treatment that targets tumor necrosis factor alpha, in moderate to severe dry eye disease.
Tanfanercept did meet a secondary outcome measure with a statistically significant improvement in Schirmer testing of tear volume at week 8. In a previous phase 3 study, Schirmer testing also met statistical significance in the treatment arm vs. the control arm.
The treatment was well tolerated. Safety findings were consistent with earlier studies, and no new adverse events were observed.
“The analyses of the Schirmer results for both phase 3 trials are highly encouraging for the impact it may have for dry eye disease patients and provides a compelling rationale for further development of tanfanercept,” Sean Jeong, MD, MBA, CEO of HanAll Biopharma, said in a press release. “HanAll intends to continue its evaluation of tanfanercept, and our future clinical program will build on the important learnings from the past three studies. Also, HanAll is exploring tanfanercept’s further potential at higher concentrations as well as additional indications.”
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