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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)

Trial Profile

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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jul 2026

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At a glance

  • Drugs Pilocarpine (Primary)
  • Indications Presbyopia
  • Focus Registrational; Therapeutic Use
  • Acronyms NEAR-2
  • Sponsors Orasis Pharmaceuticals

Most Recent Events

  • 15 Jul 2026 According to an Orasis Pharmaceuticals media release, Orasis Pharmaceuticals and Aspen Australia submitted a New Drug Application to Therapeutic Goods Administration (TGA), Australia for review and approval of pilocarpine hydrochloride ophthalmic solution 0.4% (BESKA) for the treatment of presbyopia in adults.
  • 15 Jul 2026 Results presented in the Orasis Pharmaceuticals media release.
  • 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

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