FDA Agrees VivaVision's Phase 2 Trial Can Serve as Pivotal Study for VVN461LD Eye Drop

Key Insights

• VivaVision received positive FDA comments allowing its completed Phase 2 trial of VVN461LD to count as one of two pivotal studies required for NDA filing.
• The dual JAK1/TYK2 inhibitor VVN461LD is being developed as a safer alternative to corticosteroid eye drops for post-operative inflammation following cataract surgery.
• The FDA agreement significantly reduces development timeline by requiring only one additional Phase 3 trial before NDA submission.

VivaVision Biotech announced that the FDA has provided positive preliminary comments regarding the development pathway for VVN461LD, a dual JAK1/TYK2 inhibitor for treating post-operative inflammation following cataract surgery. The Division of Ophthalmology at FDA agreed that the company's completed US Phase 2 trial (NCT06164743) may serve as one of the two pivotal trials required for New Drug Application filing.

This regulatory milestone significantly streamlines VivaVision's development timeline, as the company will now need to conduct only one additional pivotal Phase 3 trial before NDA submission. The Phase 2 study results have been published in Ophthalmology Science.

Addressing Corticosteroid Limitations

VVN461LD is positioned as a safer alternative to traditional corticosteroid eye drops, which remain the standard treatment for ocular post-operative inflammation. While corticosteroids are effective, they carry significant risks including increased intraocular pressure, delayed wound healing, and ocular infections, particularly with long-term or repeated use.

"VVN461 is positioned to be a safer but equally effective alternative to ocular corticosteroids, a highly meaningful advancement in ocular anti-inflammatory therapies for the patients," said Dr. Wang Shen, CEO of VivaVision. "These positive comments from the FDA recognized VVN461's potential as an excellent ocular anti-inflammatory drug, and it also significantly shortens the time before patients in need can use the drug."

Mechanism and Development Strategy

VVN461LD leverages a targeted, non-steroidal mechanism through dual JAK1/TYK2 inhibition to minimize the adverse effects associated with corticosteroids while maintaining similar anti-inflammatory efficacy. The drug represents a novel approach to managing post-operative ocular inflammation.

The US Phase 2 trial was partly supported by grants from the Clinical Translational Catalyst program of the Hong Kong Science and Technology Parks Corporation. VivaVision plans to discuss development plans with Chinese regulatory authorities and initiate Phase 3 clinical trials in both the US and China.

Company Pipeline

Founded in 2016, VivaVision Biotech is developing multiple ophthalmic therapies including VVN461HD for non-infectious anterior uveitis, VVN001 for dry eye syndrome, VVN1901 for neurotrophic keratitis, and VVN481 for posterior/pan-uveitis delivered via suprachoroidal injection.