Enrollment complete in Visus phase 3 trial of combination drug therapy for presbyopia
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Key takeaways:
- Visus Therapeutics completed enrollment in the BRIO-I trial, which is investigating the safety and efficacy of Brimochol PF for presbyopia treatment.
- Results from the trial are expected later this year.
Visus Therapeutics completed enrollment in a pivotal phase 3 trial investigating Brimochol PF for the treatment of presbyopia.
“Brimochol PF is anticipated to change the presbyopia treatment landscape by potentially allowing ophthalmologists and optometrists to provide their patients with a well-tolerated, once-daily eye drop that offers meaningful improvements in near vision, lasts a full workday and improves patient quality of life,” Rhett Schiffman, MD, MS, MHSA, co-founder, chief medical officer, and head of research and development at Visus, told Healio/OSN.
Image: Adobe Stock.
The double-masked, randomized, multicenter BRIO-I trial will evaluate the safety and efficacy of Brimochol PF (carbachol and brimonidine tartrate) in emmetropic phakic and pseudophakic presbyopic participants, according to a press release. The preservative-free ophthalmic solution works by reducing the size of the pupil to sharpen vision by allowing only the light rays focused on the retina to enter the eye.
“BRIO-I is a safety and efficacy study whose primary objective is to evaluate whether a
combination drug therapy of carbachol and brimonidine tartrate is superior in improving near vision than each of the two monotherapies dosed individually,” Schiffman said in the release. “By demonstrating this so-called contribution of elements in this study, Visus would become the first company to meet this FDA-required high bar for approving a combination product for presbyopia in a pivotal phase 3 study.”
The company expects to present results at meetings in the second quarter.
Editor’s note: This article was updated on March 23, 2023, to include comments from Rhett Schiffman, MD, MS, MHSA.
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