VivaVision Biotech Receives Positive FDA Feedback on VVN461LD Development for Postoperative Inflammation

VivaVision Biotech has announced encouraging written preliminary comments from the U.S. Food and Drug Administration (FDA) in advance of a planned Type C meeting, originally scheduled for early June 2025. The comments relate to the development of VVN461LD, a potent dual JAK1/TYK2 inhibitor intended for the treatment of postoperative inflammation following cataract surgery.

FDA Feedback Supports NDA Development Path

According to VivaVision, the FDA’s Division of Ophthalmology, Office of Specialty Medicine, responded positively to the company’s submitted questions regarding the regulatory strategy for VVN461LD. The agency also agreed that the U.S. Phase 2 trial (NCT06164743) may serve as one of the two pivotal trials required for a future New Drug Application (NDA) submission.

Phase 2 Study Demonstrates Promising Efficacy

The U.S. Phase 2 trial was a multicenter, randomized, double-masked, vehicle-controlled study that included 91 participants undergoing unilateral cataract surgery via phacoemulsification and lens replacement (CELR).

At Day 14 post-surgery, 60.0% (18/30) of patients in the VVN461LD 1.0% group and 53.3% (16/30) in the 0.5% group achieved anterior chamber cell (ACC) Grade 0, compared to only 19.4% (6/31) in the vehicle group, demonstrating a statistically significant reduction in inflammation (p=0.0012 and p=0.0057, respectively).

CEO Statement: Potential Alternative to Corticosteroids

Wang Shen, PhD, CEO of VivaVision, emphasized the significance of this development:

“VVN461 is positioned to be a safer but equally effective alternative to ocular corticosteroids, a highly meaningful advancement in ocular anti-inflammatory therapies for patients. 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.”

Development Outlook and Next Steps

VivaVision stated that the preliminary FDA feedback provides a clear path forward for VVN461LD’s development in the U.S. As a result, the previously scheduled Type C meeting has been canceled.

Looking ahead, the company plans to initiate Phase 3 clinical trials in both the U.S. and China, while also engaging with the Chinese Center for Drug Evaluation (CDE) to advance regulatory discussions and align development strategies across both markets.