An ophthalmic pharmaceutical company has commenced two Phase 3 clinical studies to evaluate its eye drop candidate for presbyopia.
Approximately 600 participants with presbyopia have enrolled in Orasis Pharmaceuticals’s NEAR-1 and NEAR-2 multi-centre, double-masked, parallel-group clinical trials in the US to investigate the efficacy and safety of the topical solution, currently identified as CSF-1.
CSF-1 contains a proprietary combination of existing and well-studied ingredients, contributing to a favourable safety profile.
Its mechanism of action improves near visual acuity by pupil modulation, resulting in a “pinhole effect” and an increase in the depth of field, increasing the ability to focus on near objects. The company hopes the solution will provide an alternative to conventional approaches, including reading glasses, contact lenses and invasive surgical procedures.
For the study, participants will receive one drop bilaterally twice daily for approximately two weeks, either CSF-1 or a placebo.
Researchers will be measuring the percentage of participants with a greater than or equal to three-line gain in best distance-corrected visual acuity at 40cm and no loss in best distance-corrected visual acuity greater than or equal to five letters at four metres on days one, eight and 15.
Mr Elad Kedar, CEO of Israel-based Orasis Pharmaceuticals, said the company was preparing for pre-commercialisation of the corrective eye drop as they moved into the final stage of clinical development.
“Promising results from our well powered Phase 2b study, along with the recent Series C funding, have paved a promising path for us to advance our product candidate through Phase 3 development and pre-commercialisation efforts,” he said.
“We look forward to providing this novel and non-invasive option for presbyopia to eyecare providers and patients.”
Researchers estimate the study will be completed in April 2021.