A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and Efficacy of BOL-303259-X 0.024% (Latanoprostene Bunod) Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension – APOLLO Study

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Trial Profile

A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and Efficacy of BOL-303259-X 0.024% (Latanoprostene Bunod) Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension – APOLLO Study

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2017

At a glance

  • Drugs Latanoprostene bunod (Primary) ; Timolol
  • Indications Ocular hypertension; Open-angle glaucoma
  • Focus Registrational; Therapeutic Use
  • Acronyms APOLLO
  • Sponsors Bausch & Lomb

    • Most Recent Events

    • 18 Aug 2017 According to a NicOx media release, company's exclusive licensee has submitted a response to the Complete Response Letter (CRL) received from the U.S. Food and Drug Administration (FDA) on August 7, 2017 concerning the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024% for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension.
    • 07 Aug 2017 According to a Valeant Pharmaceuticals International media release,it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.
    • 10 Jun 2017 Biomarkers information updated
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