Neurotrophic keratitis

VVN461, a dual JAK1/TYK2 inhibitor as a non-steroidal anti-inflammatory agent, has met primary endpoints, demonstrating non-inferior efficacy compared to the standard therapy, prednisolone acetate (PA) in treating NIAU Clinically meaningful reductions in inflammation compared to baseline observed as early as Day 3 Strong safety profile with no substantial treatment-related adverse events reported WENZHOU, China, April 24, 2025 /PRNewswire/ -- VivaVision Biotech (VivaVision), a clinical-stage, privately held biotechnology company focused on developing innovative treatments for ocular diseases, today announced positive topline results from its phase 2 clinical trial of VVN461, a potent dual JAK1/TYK2 inhibitor for the treatment of Non-Infectious Anterior Uveitis (NIAU) in China. This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at 10 clinical sites in China enrolling 86 subjects with NIAU. Subjects were randomized into three groups (VVN461-1.0%, VVN461-0.5%, and prednisolone acetate-1.0%) and received treatments for 28 days. Prednisolone acetate is the first-line corticosteroid therapy for NIAU. Both 0.5% and 1% of VVN461 ophthalmic solutions showed non-inferior efficacy compared to active control PA for its primary endpoint: subjects treated with VVN461 had 2 step decrease in ACC grade vs. subjects treated with prednisolone acetate (p <0.001). Note: ACC (anterior chamber cells) were evaluated using SUN grading scale. Both VVN461 dose groups demonstrated statistically significant and clinically meaningful improvements from baseline across most primary and secondary endpoints. The efficacy of VVN461 groups were comparable to prednisolone acetate group. No substantial treatment-related adverse events were reported, confirming VVN461's excellent safety profile. Full data will be reported in future publications in conferences and journals. "I am very pleased to see that VVN461 showed non-inferior efficacy to prednisolone acetate in the phase 2 clinical trial for NIAU in China. This is a very significant and potentially disruptive progress in treating uveitis." said Professor. Liu Yang, Director of Ophthalmology at Peking University First Hospital, "We hope that this safe, highly efficacious and accessible non-steroidal medicine, VVN461 would be available to benefit patients in near future." Uveitis is the inflammation of uvea which consists of the iris, ciliary body, and choroid. Uveitis affects approximately 3 million patients in China with ~60% classified as NIAU . Uveitis may recur and be chronic, and it is a leading cause of vision loss accounting 10–20% of cases of acquired legal blindness. Treatment of NIAU typically involves the use of topical steroids, which are associated with adverse effects such as increased intraocular pressure, delayed wound healing, and ocular infections. Repeated or chronic use of topical steroids may lead to severe side effects, such as ocular hypertension and cataract. Therefore, the effective control of uveitis inflammation with minimization of side effects is critically needed. VVN461 offers a promising alternative, leveraging its targeted, non-steroidal mechanism to minimize these risks while maintaining anti-inflammatory efficacy. VivaVision has scheduled a discussion with Chinese CDE and is planning to request a type C meeting with FDA about phase 3 clinical trials. About VivaVision Biotech Founded in 2016, VivaVision Biotech is a clinical-stage pharmaceutical company dedicated to advancing best-in-class therapies with additional investigational drug candidates for ocular diseases. The company's leading pipeline assets include: VVN461: a non-steroidal dual JAK1/TYK2 immunomodulator for post-operative inflammation after cataract surgery and non-infectious anterior uveitis. VVN001: an investigational treatment for dry eye syndrome. VVN1901: a therapy for targeting neurotrophic keratitis VVN481: a non-steroidal dual JAK1/TYK2 inhibitor for suprachoroidal delivery to treat posterior/pan-uveitis and posterior inflammatory diseases VVN432: a non-steroidal JAK inhibitor nasal spray for chronic rhinosinusitis (CRS) In addition to its pipeline, VivaVision is actively engaged in the discovery and development of additional therapies for anterior and posterior segment eye diseases to address unmet patient needs. For more information, please visit . China Media Contact Ruby SUN Phone: +86 181-1619-2461 Email: [email protected] SOURCE VivaVision Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Oculis kicked off the year on a positive note with a mid-stage success in a rare ophthalmic condition, setting the stage for clinical development in the US. The Swiss drugmaker’s serum glucocorticoid kinase-2 activator OCS-05 met the primary endpoint in the Phase 2 ACUITY trial in 36 patients in France with acute optic neuritis who were taking steroids, according to a Monday release . There was no difference between the two treatment arms in the percentage of subjects with abnormal electrocardiogram parameters, the company said. Oculis also said the 3 mg/kg dose of the drug was effective, producing a statistically significant 18-letter improvement in low contrast letter acuity compared with placebo at three months. Treated patients also saw a 43% improvement in ganglion cell-inner plexiform layer thickness versus placebo and a 28% improvement in retinal nerve fiber layer thickness. Mark Kupersmith, vice chair of translational research at Icahn School of Medicine, said in the release that if the Phase 2 data are replicated in larger studies, they could have “profound implications, not only for this condition, but potentially for [multiple sclerosis] and other optic nerve disorders as well as glaucoma.” In November, Stifel analysts wrote that each of Oculis’ programs have blockbuster potential. The FDA has cleared Oculis’ IND application for OCS-05, allowing the start of clinical development in the US. The biotech currently has around $105 million to $110 million in cash, equivalents and short-term investments to help fund this work. While the company plans to stick with an IV formulation of OCS-05 for further development in acute optic neuritis, it is also working on a topical version of the drug for neurotrophic keratitis which is expected to enter IND-enabling studies this year. “We are thinking about other, I would say, more friendly formulations for chronic diseases such as [intravitreal] and subcutaneous,” CEO Riad Sherif told analysts and investors on a Monday call. The Phase 2 success is a welcome change for the Zug-based drugmaker, which faced a series of setbacks in 2024. In June, Oculis’ candidate for dry eye disease missed statistical significance in a mid-stage test. Two months later, the company was forced to pull the plug on a second Phase 3 trial for its lead eye drop program for inflammation and pain following ocular surgery due to an undisclosed “third-party administrative error.” But Oculis said at the time that it plans to go ahead with an FDA filing based on data from a previous late-stage trial and a Phase 2 study. Editor’s note: This article was updated to add comments from a company call.

VVN461, a non-steroidal dual JAK1/TYK2 immunomodulator, achieves primary endpoint, demonstrating statistical and clinical efficacy compared to vehicle in treating post-operative inflammation following cataract surgery Statistically and clinically meaningful reductions in inflammation and ocular pain observed as early as Day 3 Very favorable safety profile with low adverse event rate in active groups WENZHOU, China and SAN DIEGO, Dec. 3, 2024 /PRNewswire/ -- VivaVision Biotech (VivaVision), a clinical-stage, privately held biotechnology company focused on developing treatments for ocular diseases, today announced positive topline results from its U.S. Phase 2 clinical trial of VVN461-CS-201, a potent non-steroidal dual JAK1/TYK2 immunomodulator for the treatment of post-operative inflammation following cataract surgery. The multicenter, randomized, double-masked, vehicle-controlled study enrolled 91 subjects who underwent routine unilateral cataract extraction by phacoemulsification and lens replacement (CELR). Subjects were randomized into three groups (VVN461 1.0%, VVN461 0.5%, and vehicle) and received four doses daily (QID) for 14 days. VVN461 demonstrated statistical and clinical improvements across all primary and secondary endpoints compared to vehicle. Key findings include: Primary Endpoint: At Day 14, 60.0% (18/30) (1.0%) and 53.3% (16/30) (0.5%) of subjects 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.) Secondary Endpoints: Clinically significant reductions in anterior chamber flare (ACF) and subject-reported ocular pain, with therapeutic effects observed as early as Day 3. Exploratory Findings: Over the 14 days of the study, only 4 subjects (combined active groups) out of 61 in the VVN461 groups required rescue medication, compared to 15 out of 30 in the vehicle group, indicating faster and more effective post-operative healing and improved baseline ocular comfort. The adverse event rate with both concentrations of VVN461 was low, with only mild severity, and similar to its vehicle, confirming VVN461's safety profile. "VVN461's Phase 2 results highlight its potential as a safer alternative to corticosteroids for post-operative inflammation," said Jason Bacharach, M.D., Founder and Director of Research at North Bay Eye Associates. "The positive efficacy of VVN461, combined with its excellent safety profile, addresses a critical need for anti-inflammatory therapies with fewer corticosteroid-associated risks." Traditional corticosteroid eye drops, while effective, are associated with adverse effects such as increased intraocular pressure, delayed wound healing, and ocular infections, particularly with long-term use. VVN461 offers a promising alternative, leveraging its targeted, non-steroidal mechanism to minimize these risks while maintaining anti-inflammatory efficacy. "VVN461 represents a meaningful step forward in ophthalmic anti-inflammatory therapy," said Dr. Wang Shen, CEO of VivaVision. "The reductions in inflammation and ocular pain observed as early as Day3, combined with a favorable safety profile, underscore the potential impact of this therapy for patients. These results provide a strong foundation to advance our efforts around a Phase 3 clinical trial of VVN461 in the U.S." VivaVision is also conducting Phase 2 studies for VVN461 in non-infectious anterior uveitis (NIAU) in China. About VivaVision Biotech Founded in 2016, VivaVision Biotech is a clinical-stage pharmaceutical company dedicated to advancing best-in-class and first-in-indication therapies with additional investigational drug candidates for ocular diseases. The company's leading pipeline assets include: VVN461: non-steroidal dual JAK1/TYK2 immunomodulator for post-operative inflammation after cataract surgery and non-infectious anterior uveitis. VVN001: an investigational treatment for dry eye syndrome. VVN1901: a therapy targeting neurotrophic keratitis VVN481: a non-steroidal dual JAK1/TYK2 inhibitor for suprachoroidal delivery targeting treatment of posterior/pan-uveitis In addition to its pipeline, VivaVision is actively engaged in the discovery and development of additional therapies for anterior and posterior segment eye diseases to address unmet patient needs. For more information, please visit . US Media Contact Kellie Shuck, RHMM Inc. Phone: +1 682-553-7283 Email: [email protected] China Media Contact Ruby SUN Phone: +86 181-1619-2461 Email: [email protected] SOURCE VIVAVISION BIOTECH LTD WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED