A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-2 Study: Near Eye-vision Acuity Restoration)
Latest Information Update: 08 Apr 2024
At a glance
- Drugs Pilocarpine (Primary)
- Indications Presbyopia
- Focus Registrational; Therapeutic Use
- Acronyms NEAR-2
- Sponsors Orasis Pharmaceuticals
- 11 Jan 2024 Results of pooled analysis ( n=613 from studies NCT04599933 and NCT04599972) assessing safety and efficacy of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia published in the Clinical Therapeutics
- 18 Oct 2023 According to an Orasis Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) has approved QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is expected to be commercially available in the U.S. in the first half of 2024.
- 21 Feb 2023 According to an Orasis Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023.