Orasis Pharmaceuticals announces positive Phase III results of eye drop candidate
pharmafile | April 22, 2022 | News story | Medical Communications |Â Â Â
Orasis Pharmaceuticals has announced that the Phase III NEAR-1 and NEAR-2 clinical trials, which evaluated the efficacy and safety of CSF-1, its novel eye drop candidate, met their primary and key secondary endpoints.
In both trials, CSF-1 met its primary and key secondary endpoints.
“Currently, optometry delivers 85% of all comprehensive eye care exams, making a difference in the vision of so many patients,” said Paul Karpecki, O.D., FAAO. “New and existing presbyopia patients will come into an optometry practice that now offers presbyopia drops, as well as contact lenses and spectacles – all playing a role in the management of the patients looking for options.”
“These statistically significant and clinically meaningful results are promising as eye care providers are eager to find alternate treatment options to improve quality-of-life for their patients with presbyopia, many of whom rely solely on reading glasses, which can be cumbersome,” said Edward Holland, MD, Professor of Ophthalmology, University of Cincinnati and Director of Cornea, Cincinnati Eye Institute. “Based on the efficacy and excellent tolerability demonstrated with such a minimum effective dose, I would see CSF-1 as a clear place to start many presbyopia patients.”
“We are extremely pleased with these positive results, which mark a significant milestone for CSF-1 and Orasis, and they position us well to be the next product to launch in this exciting category,” added Elad Kedar, CEO of Orasis Pharmaceuticals. “The potential of CSF-1 to provide a first-line treatment option for people living with presbyopia is promising and we look forward to working with regulatory authorities to advance CSF-1 toward commercialisation.”
Lina Adams
