VivaVision Biotech receives positive preliminary comments from FDA on development of VVN461LD

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VivaVision Biotech announced it has received written preliminary comments for the Type C meeting to be held in early June 2025 with the US Food and Drug Administration (FDA).

According to the company, the FDA’s comments were positive regarding the questions that it had prepared for the development of VVN461LD, a potent dual JAK1/TYK2 inhibitor for the treatment of postoperative inflammation following cataract surgery.

Additionally, the Division of Ophthalmology, Office of Specialty Medicine at the FDA agreed with the company that its US phase 2 trial (NCT06164743) may serve as 1 of the 2 pivotal trials required for NDA filing of VVN461LD as treatment for ocular postoperative inflammation.

The phase 2 US trial of VVN461LD was a multicenter, randomized, double-masked, vehicle-controlled study enrolled 91 participants who underwent routine unilateral cataract extraction with phacoemulsification and lens replacement (CELR). At day 14, 60.0% (18/30) (1.0%) and 53.3% (16/30) (0.5%) of patients in the VVN461 groups achieved anterior chamber cell (ACC) Grade 0 compared to 19.4% (6/31) in the vehicle group (p=0.0012 and p=0.0057, respectively.)

Wang Shen, PhD, CEO of VivaVision, commented on the meeting in a press release from the company.

"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 Shen. "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."

The company noted that preliminary comments have provided a clear path forward in the US to develop VVN461LD, and therefore a formal meeting is no longer necessary and is subsequently canceled. VivaVision is also planning to discuss with the Chinese CDE and will initiate phase 3 clinical trials in both the US and China in the near future.

References:

1. VivaVision announces positive comments from FDA for the type c meeting regarding VVN461LD for post-operative inflammation - Agreeing the phase 2 trial to be served as one of the two pivotal studies. Published June 9, 2025. Accessed June 10, 2025. https://www.prnewswire.com/news-releases/vivavision-announces-positive-comments-from-fda-for-the-type-c-meeting-regarding-vvn461ld-for-post-operative-infalmmation--agreeing-the-phase-2-trial-to-be-served-as-one-of-the-two-pivotal-studies-302476201.html

2. Hutton D. VivaVision Biotech reports positive Phase 2 trial results of VVN461 for postoperative inflammation treatment following cataract surgery. Published December 5, 2024. Accessed June 10, 2025. https://www.ophthalmologytimes.com/view/vivavision-biotech-reports-positive-phase-2-trial-results-of-vvn461-for-postoperative-inflammation-treatment-following-cataract-surgery