All three investigational candidates studied in VIVID achieved the endpoint of three lines of improvement in binocular near visual acuity without losing one line of distance vision with a minimum responder rate of 83% at one hour.
In all three formulations, at least 35% of research participants met this same endpoint at nine hours. Furthermore, all three formulations were well-tolerated and had good safety profiles. Based on these encouraging results, the company intends to begin Phase 3 pivotal trials soon.
“We are very encouraged by the VIVID study topline clinical data, which demonstrate that our clinical development program has delivered drug candidates which provide a durable improvement in visual acuity with favorable tolerability and safety profiles,” said Rhett Schiffman, MD, MS, MHSA, co-founder, chief medical officer and head of research and development at Visus Therapeutics.
“We know that presbyopia has a profound impact on quality of life for patients. These positive results provide further confidence that we are well-positioned to bring to market the longest-lasting eye drop in the presbyopia category, which would be a meaningful breakthrough treatment for these individuals. We are excited to initiate our Phase 3 pivotal trials.”
Topline Highlights from VIVID Phase 2 Trial
1. In the per-protocol population, a minimum of 83% of subjects treated with BRIMOCHOL, BRIMOCHOL F, or Carbachol F achieved the endpoint of 3 lines of improvement in binocular near visual acuity under mesopic conditions without losing 1 line of distance vision at 1 hour. A minimum of 82%, 52%, and 35% of subjects met this same endpoint at 3, 7, and 9 hours, respectively.
2. In key secondary endpoints, BRIMOCHOL and BRIMOCHOL F achieved a mean improvement in binocular near visual acuity of a minimum of 18 ETDRS letters, almost 4 lines, as early as 30 minutes and a minimum of 12 letters at 9 hours.
3. BRIMOCHOL, BRIMOCHOL F, and Carbachol F were well-tolerated with no unexpected adverse events. Adverse events exceeding 5% included temporary burning and stinging upon instillation, headache, and brow ache. No serious adverse events were reported.
“FDA approval of Allergan’s VUITY, the first pharmacologic approved for the treatment of presbyopia, it is truly exciting to see this category come to fruition. We are pleased the VIVID study data exceeded our expectations, demonstrating a clear opportunity to commercialize long-acting miotic formulations,” Shiffman added.
The VIVID clinical trial was a randomized, dose-ranging, multi-center, three-arm crossover research that assessed the safety and efficacy of carbachol and brimonidine tartrate fixed-dose combinations (BRIMOCHOL and BRIMOCHOL F) compared to a similarly manufactured preservative-free carbachol.
85 subjects, ages 45 to 80, with emmetropic phakic and pseudophakic presbyopia were enrolled at three U.S. sites. In any of these study populations, the trial was not designed to attain statistical significance. The VIVID study's full findings will be revealed at a future medical meeting.
“These are very encouraging preliminary results for the millions of people living with presbyopia and the eye care professionals who treat them,” said Eric D. Donnenfeld, MD, founding partner of Ophthalmic Consultants of Long Island and Clinical Professor of Ophthalmology at NYU.
“Eye drops are emerging as an important new treatment option for correcting age-related loss of near vision. I see tremendous clinical value in a long-acting, preservative-free eye drop that can improve near vision throughout the workday while avoiding the potential toxicity of preservatives. What’s really exciting is that these study results demonstrate the potential of drug candidates that can be studied in a larger treatment population.”
“Currently, drugstore reading glasses are the most common treatment option for people as they lose their near vision with age. This means that many people aren’t getting regular comprehensive eye exams, and as such, more serious eye conditions are going undiagnosed,” said David Evans, OD, an optometrist at Total Eye Care in Memphis, Tenn., and a clinical investigator in the VIVID trial.
“The availability of a once-daily, preservative-free eye drop such as those evaluated in the VIVID study could attract millions of people into eye care practices nationwide, creating opportunities to not only improve visual performance but also advance eye health overall for this patient population.”