VivaVision Biotech Ltd. announced that a phase 2a study assessing the efficacy and safety of VVN539 for the treatment of primary open-angle glaucoma (POAG) has met its primary endpoints.
Give me some company background.
Founded in 2016 and based in Shanghai, China, VivaVision Biotech is a clinical-stage research and development biopharmaceutical company focused on developing and delivering new therapies for chronic ocular and dermal inflammatory diseases.
In addition to VVN539 for glaucoma, the company is also developing VVN001 for dry eye in the United States. See here for its complete pipeline.
Now talk about VVN539.
VVN539 is a first-in-class small molecule developed with a novel rho-kinase (ROCK) inhibitor and nitric oxide (NO) dual mechanism of action (MOA); it works to directly target the trabecular meshwork by increasing the outflow of aqueous humor, with the intended result of lowering intraocular pressure (IOP).
It is currently undergoing clinical trials in the United States and China.
And this trial?
The randomized, double-masked, vehicle-controlled, dose-response phase 2a trial (NCT05451329) enrolled 63 patients (ages 18+) diagnosed with either POAG or ocular hypertension (OHT) in both eyes.
The first-in-human (FIH) study assessed the safety and ocular hypotensive efficacy of VVN539 in three dosing regimens for 7 to 9 days:
- Once a day in the morning(QAM)
- Once a day in the evening (QPM)
- Twice a day (BID)
What were the dosages?
Patients were randomized to receive the following doses:
- VVN539 0.02%: QAM, QPM, and BID tested for 7-9 days
- VVN539 0.04%: QAM, QPM, and BID tested for 7-9 days
- VVN539 vehicle: QAM, QPM, and BID tested for 7-9 days
*Note: Clinical Trials does not indicate the number of participants per each dosage.
What was measured?
The primary outcome included mean IOP, taken on Day 7, Day 14, and Day 21 at three serial timepoints: 8 am, 10 am, and 4 pm.
Secondary outcomes included mean change in IOP from baseline on Day 7, Day 14, and Day 21 at the same time points.
Further, safety measurements were taken for the incidence of adverse events (at Day 21).
Findings?
A clinically and statistically significant decrease was noted in IOP among patients with POAG and OHT, while VVN539 0.04% was statistically superior to the vehicle across all time points in the 21-day period.
A reduction in IOP of 5 to 6 mmHg from the unmedicated baseline was also noted for VVN539 0.04%.
How about VVN539 0.02%?
That dosage showed a statistically significant decrease in IOP from unmedicated baseline compared to the vehicle at the majority of time points, according to the company.
Conversely, the vehicle illustrated an IOP reduction of 1 to 2 mmHg among patients.
Any adverse events?
The company did not note any adverse events.
What’s next?
According to VivaVision, future clinical trials will focus on comparing VVN539 to a first-line anti-glaucoma therapy in a larger patient population.