Phase 2 VIVID study presents positive topline data for presbyopia treatment options

Visus Therapeutics Inc. is reporting positive topline results from VIVID, the company’s Phase 2 study of three novel topical ophthalmic formulations under investigation for the treatment of presbyopia.

According to the company, 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. A minimum of 35% of subjects in the study met this same endpoint at nine hours in all three formulations.

Additionally, all three formulations were well-tolerated and exhibited favourable safety profiles. Based on these positive outcomes, the company plans to commence Phase 3 pivotal trials shortly.

Dr Rhett Schiffman, co-founder, chief medical officer and head of research and development at Visus Therapeutics, said company officials are very encouraged by the VIVID study topline clinical data, which demonstrate that the company’s clinical development program has delivered drug candidates which provide a durable improvement in visual acuity with favourable tolerability and safety profiles.

“We know that presbyopia has a profound impact on quality of life for patients,” Dr Schiffman said in a statement. “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.”

VIVID Phase 2 Trial Topline Highlights

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.

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.

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.

According to Ben Bergo, co-founder and CEO at Visus Therapeutics, the completion of the VIVID study marks an important milestone for the company.

“In light of the recent 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,” Bergo said in a statement. “We are pleased the VIVID study data exceeded our expectations, demonstrating a clear opportunity to commercialize long-acting miotic formulations.”

The VIVID clinical trial (NCT04774237) was a double-masked, randomized, dose-ranging, multi-centre, three-arm crossover study designed to evaluate the safety and efficacy of fixed-dose combinations of carbachol and brimonidine tartrate (BRIMOCHOL and BRIMOCHOL F) compared to a similarly formulated preservative-free carbachol.

The trial enrolled 85 subjects, ages 45 to 80, with emmetropic phakic and pseudophakic presbyopia at three U.S. sites. The trial was not designed to achieve statistical significance in any of these study populations. Full results from the VIVID study will be presented at future medical meetings.

According to Dr Eric D. Donnenfeld, founding partner of Ophthalmic Consultants of Long Island and Clinical Professor of Ophthalmology at NYU, the preliminary results are encouraging for millions of patients people living with presbyopia and the eye care professionals who treat them.

“Eye drops are emerging as an important new treatment option for correcting age-related loss of near vision,” he said in a statement. “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.”

Dr David Evans, an optometrist at Total Eye Care in Memphis, Tenn., and a clinical investigator in the VIVID trial, noted that drugstore reading glasses currently 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,” he said in a statement. “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.”

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