VivaVision Biotech Receives Positive FDA Feedback for VVN461LD Trial in Eye Inflammation Treatment

Positive FDA Response Marks a Milestone for VivaVision Biotech

On June 9, 2025, VivaVision Biotech, a late clinical-stage biotech firm specializing in innovative ophthalmic treatments, announced significant progress in its efforts to bring VVN461LD, a dual JAK1/TYK2 inhibitor, to market. This drug is specifically designed to treat inflammation following cataract surgery, which is a common postoperative complication.

VivaVision received positive preliminary comments following their Type C meeting with the U.S. Food and Drug Administration (FDA). This formal meeting is a vital step where drug sponsors discuss the development and regulatory strategies of their products with the FDA. The favorable feedback acknowledges the potential of VVN461LD as a valuable treatment option, paving the way for its Phase 2 trial to be considered one of the two pivotal studies for regulatory filing.

Dr. Wang Shen, CEO of VivaVision, expressed enthusiasm over the FDA's recognition of the drug's potential, calling VVN461LD a safer alternative to traditional corticosteroids. These corticosteroids, although effective in managing inflammation, often come with unwanted side effects, including increased intraocular pressure and delayed wound healing. VVN461LD seeks to maintain anti-inflammatory efficacy while minimizing these risks.

The trial data for the U.S. Phase 2 study of VVN461 has already been published in Ophthalmology Science, highlighting its scientific credibility. The positive comments from the FDA also mean that a formal follow-up meeting is now deemed unnecessary, allowing VivaVision to expedite its plans for the next phases of development.

Beyond the positive FDA engagement, the U.S. Phase 2 study was significantly backed by the Clinical Translational Catalyst (CTC) program of the Hong Kong Science and Technology Parks Corporation (HKSTP), aiming to enhance Hong Kong’s role as a hub for biomedical innovation. This support reflects a broader commitment to fostering translational medicine for improved patient care in the region.

VivaVision looks forward to initiating Phase 3 trials in both the United States and China, further tapping into the potential of VVN461LD and its accompanying pipeline projects. Apart from VVN461LD, the company is also advancing other therapies aimed at addressing critical ocular diseases, including VVN461HD for anterior uveitis and VVN001 for dry eye syndrome.

As it stands, VivaVision Biotech is at a critical juncture. With clear FDA encouragement, the path for VVN461LD's development seems remarkably promising, offering hope for improved treatment options for patients recovering from eye surgeries. More than just a pharmaceutical endeavor, VivaVision exemplifies innovation that is responsive to the specific needs of ocular health and sheds light on how medical advancements can come about through constructive collaboration with regulatory bodies.

For more information on their innovative therapies, please visit www.vivavisionbio.com.