Orasis Pharmaceuticals, an Israeli based ophthalmic pharmaceutical company announced the start of Phase 3 clinical studies in the US to evaluate novel eye drop candidate, CSF-1, designed to provide temporary correction of presbyopia.
The proprietary eye drop exerts its pharmacological action through pupil modulation. In clinical trials, the medication was dosed twice daily allowing patients to choose how and when to use it.
According to information provided by the company, the eye drop candidate is a proprietary combination of low-dose pilocarpine combined with multi-faceted vehicles designed to achieve the optimal balance between efficacy, safety and comfort.
The ophthalmological use of pilocarpine is well known. The side effect profile of pilocarpine includes eye irritation, temporary blurred vision, poor vision in low light, and headache or brow ache.
The company told Optik, “Clinical trials to date have demonstrated CSF-1 being a well-tolerated formulation with only mild and temporary adverse events.”
Further, a Phase 2 study completed at the end of 2019 showed no impact on distance or night vision, according to the company.
The Phase 3 studies are multi-centre, double-masked, parallel-group clinical trials in the US enrolling approximately 600 participants with presbyopia to further evaluate the efficacy and safety of CSF-1.
Upon completion of these studies and FDA approval the company will explore launches in additional countries. No specific plans for commercialization in Canada were provided upon request.
One day, patients may opt to preemptively instil an eye drop instead of fumbling to find readers to view the fine print on a menu.
About Orasis Pharmaceuticals
Orasis
is an emerging ophthalmic pharmaceutical company committed to making near
vision clear again for people with presbyopia. Orasis’ novel proprietary
formulation, designed to achieve an optimal balance between efficacy, safety
and comfort, has the potential to position the company as an emerging
leader in the presbyopia space. Orasis is based in Herzliya, Israel. For more
information, visit https://www.orasis-pharma.com
