This section highlights FDA-related milestones and regulatory updates for drugs developed by Vyome (HIND).
Over the past two years, Vyome has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VT-1908 and VT-1953. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
VT-1908 FDA Regulatory Events
VT-1908 is a drug developed by Vyome for the following indication: To Treat Uveitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VT-1908
- Announced Date:
- September 17, 2025
- Indication:
- To Treat Uveitis
Announcement
Vyome Holdings, Inc presented results from its preclinical studies investigating VT-1908 (the first topical formulation of mycophenolate) for treating uveitis at the recent Annual Meeting of the American Society for Pharmacology and Experimental Therapeutics (1).
AI Summary
At the recent Annual Meeting of the American Society for Pharmacology and Experimental Therapeutics, Vyome Holdings, Inc. presented preclinical results for VT-1908, the first topical formulation of mycophenolate designed to treat uveitis. In a model of anterior uveitis, twice-daily VT-1908 eye drops achieved the desired drug concentration in the front chamber of the eye and significantly lowered the uveitis score (P<0.001). Testing showed VT-1908 matched the effectiveness of a standard steroid but without risks like cataracts or increased eye pressure.
Dr. Shiladitya Sengupta, Vyome’s co-founder, said VT-1908 could replace steroids and help patients who cannot use them. CEO Venkat Nelabhotla added that Vyome plans to start a Phase 1/2 clinical trial in the second half of 2026. While uveitis is the initial focus, the company aims to address the broader $20 billion ocular inflammation market.
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VT-1953 FDA Regulatory Events
VT-1953 is a drug developed by Vyome for the following indication: Malignant Fungating Wounds.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VT-1953
- Announced Date:
- September 4, 2025
- Indication:
- Malignant Fungating Wounds
Announcement
Vyome Holdings, Inc announced the interim results from its investigator-initiated Phase 2 PoC study of VT-1953 topical gel in patients with malignant fungating wounds ("MFW").
AI Summary
Vyome Holdings announced interim results from its investigator-initiated Phase 2 proof-of-concept study of VT-1953 topical gel in patients with malignant fungating wounds (MFW). These findings were shared at the American Association for Cancer Research annual meeting and show promising early efficacy.
The study met its primary endpoint, with VT-1953 significantly reducing wound malodor (P<0.001). Patients also reported major pain relief (P<0.001) and improved quality of life (P<0.001) as secondary and exploratory endpoints, respectively. No clinically significant adverse trends were noted during treatment.
VT-1953 works by inhibiting inflammatory drivers and targeting both TLR-MD2 and bacterial DNA gyrase to control symptoms. Prior studies have shown the gel is well tolerated in over 500 patients, underscoring its favorable safety profile.
Co-founder Dr. Shiladitya Sengupta will host a live video conference on September 8 to discuss these interim results and outline the path toward full data release in October 2026.
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