HIND News & Events

Vyome Holdings announced the publication of its preclinical data validating the efficacy and safety of VT-1908 as a potential treatment for uveitis in the peer-reviewed Journal of Ophthalmic Inflammation and Infection, a Springer-Nature journal. Uveitis refers to the immune-inflammation of the eye, and accounts for 10%-15% of all cases of blindness in the developed world. In the United States alone, it is associated with an estimated 30,000 new cases of legal blindness annually, and represents an estimated $3B market opportunity by 2032. In this publication, topical eye drops of VT-1908 resulted in the desired concentration of the active drug being achieved in the eye without any irritation or signs of toxicity. VT-1908-treated eyes showed a significant reduction in the uveitis score with reduced lymphocyte counts in the anterior chamber compared to vehicle control. VT-1908 was found to be as effective as topical prednisone in the preclinical model.

Vyome Holdings announced that it has filed for orphan drug status for VT-1953, its lead clinical program.

Vyome Holdings announced the final results from an investigator-initiated Phase 2 proof of concept study of VT-1953 topical gel in people with malignant fungating wounds. VT-1953, an immunomodulator for this indication, achieved both its primary and secondary endpoints. With this result, Vyome plans to advance to Phase III pivotal trial and seek FDA approval. On the primary endpoint of bad smell or malodor scored by the investigator, patients treated with VT-1953 achieved a statistically significant improvement from what was a very severe bad smell at baseline to a much milder smell within just 14 days of treatment. The improvement at the end of 14 days seen with VT-1953 was statistically significant compared with vehicle-treated patients. A statistically significant improvement was seen with VT-1953 as early as Day 7. VT-1953 was well-tolerated by patients. On the secondary endpoint of patient-reported impact of bad smell on the quality of life, VT-1953 resulted in a statistically significant improvement compared to vehicle-treatment by Day 14. Patients treated with VT-1953 also reported a clinically significant improvement in pain symptoms by Day 14. On a patient-reported Quality of life component score, treatment with VT-1953 resulted in a significant improvement by Day 14 compared to baseline and vs vehicle-treatment.