October 18,Orasis Pharmaceuticals Announces FDA ApprovalCSF-1（0.4% PilocarpineDropEye Drops) for the treatment of presbyopia.
CSF-1 is aByLow-dose pilocarpine (0.4%) and variousComposed of carriersPreservative-Free Formula Eye Drops, it achieves this by adjusting the pupil, creating a "pinhole effect" and increasing the depth of field, thusImprove near vision. The press release noted,CSF-1Can achieve therapeutic effects、The Best Balance Between Safety and ComfortFlatHeng Effect。This NDA is based on two Phase III studies of CSF-1 for the treatment of presbyopia.Key results of NEAR-1 (NCT04599933) and NEAR-2 (NCT04599972). These two studies enrolled a total of 613 patients aged 45 to 64, receiving treatment twice daily.CSF-1 Treatment. After 8 days of treatment,CSF-1 has been reachedPrimary and key secondary endpoints were significantly improvedCorrected Near Vision Under Distant Vision Correction (DCNVA) ImproveEfficacy of 3 lines or more,And the loss of long-distance vision is less than one line.In acceptanceCSF-1One hour after the first dose, 40% of patients achieved an improvement of 3 lines or more. One hour after the second dose, the proportion of patients increased to 50%.In addition, CSF-1 achieved a 3-line improvement at all measurement time points from Day 1 to Day 15.CSF-1. Demonstrates good safety and tolerability in both studies.Such asIncluding headache, pain at the infusion site, etc.Most Common Adverse EventsThe incidence rates were respectively6.8% and 5.8%; among all subjects, only 2.6% experienced moderate treatment-related adverse events, with the rest being mild.Presbyopia is a common progressive eye disease. Due to the hardening and loss of elasticity of the lens, it becomes difficult for the eye to change shape, making it hard to focus nearby objects onto the retina, causing patients to have difficulty seeing close objects clearly. Statistics show that there are over 2 billion people worldwide suffering from presbyopia, mostly occurring after the age of 40. Since presbyopia cannot be prevented or reversed, patients’ quality of life is greatly affected, creating an urgent need for more innovative therapies to improve the current situation.AbbVie'sVuity（1.25% Pilocarpine Hydrochloride Eye Drops) isWorld's First Approved Presbyopia Eye Drops, which was approved for marketing by the FDA in October 2021. This eye dropUse once daily, takes effect within 15 minutes, lasting up to 6 hours; while receivingAfter CSF-1 treatment,Vision improvement can be achieved in as little as 20 minutes, with effects lasting up to 8 hours.Copyright © 2023 PHARMCUBE. All Rights Reserved.
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