Nonsteroidal immunomodulator meets endpoints in cataract surgery postop inflammation trial
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Key takeaways:
- More patients who received VVN461 achieved anterior chamber cell grade 0 compared with patients who received vehicle.
- The trial also met key secondary endpoints.
A phase 2 clinical trial of VVN461, a nonsteroidal dual Janus kinase 1/tyrosine kinase 2 immunomodulator, met the primary endpoint of statistical and clinical efficacy vs. vehicle for the treatment of inflammation after cataract surgery.
According to a press release from VivaVision Biotech, 91 patients undergoing routine unilateral cataract extraction in the multicenter, randomized, double-masked, vehicle-controlled study were randomly assigned to receive VVN461 1% (30 patients), VVN461 0.5% (30 patients) or vehicle (31 patients). Patients were treated four times a day for 14 days.
At day 14, 60% of patients who received VVN461 1% and 53.3% of patients who received VVN461 0.5% achieved anterior chamber cell grade 0 compared with 19.4% of patients who received vehicle, achieving the primary endpoint (P = .0012 and P = .0057, respectively).
In addition, the trial met key secondary endpoints of reductions in anterior chamber flare and subject-reported ocular pain with VVN461, “with therapeutic effects observed as early as day 3,” the release said.
In the combined VVN461 groups, four patients required rescue medication compared with 15 out of 30 patients who received vehicle. The adverse event rate was similar to vehicle, confirming the safety of VVN461.
“VVN461’s phase 2 results highlight its potential as a safer alternative to corticosteroids for postoperative inflammation,” Jason Bacharach, MD, founder and director of research at North Bay Eye Associates in California, said in the release. “The positive efficacy of VVN461, combined with its excellent safety profile, addresses a critical need for anti-inflammatory therapies with fewer corticosteroid-associated risks.”
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