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Dexamethasone ophthalmic - Oculis Pharma

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Drug Profile

Dexamethasone ophthalmic - Oculis Pharma

Alternative Names: dexamethasone cyclodextrin nanoparticle eye drops; dexamethasone/γCD nanoparticle; DexNP; OC-118; OCS-01; OPTIREACH

Latest Information Update: 30 Aug 2024

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At a glance

  • Originator Oculis Pharma
  • Developer Oculis Pharma; Tel Aviv University
  • Class Anti-inflammatories; Antiallergics; Antiemetics; Antihyperglycaemics; Antineoplastics; Antirheumatics; Eye disorder therapies; Fluorinated steroids; Glucocorticoids; Ketones; Non-opioid analgesics; Phosphates; Pregnadienetriols; Small molecules; Sodium compounds; Vestibular disorder therapies
  • Mechanism of Action Glucocorticoid receptor agonists; Immunosuppressants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Diabetic macular oedema; Postoperative inflammation; Postoperative pain
  • Phase II Retinal oedema; Uveitis

Most Recent Events

  • 27 Aug 2024 Oculis Pharma plans pre-NDA meeting in August 2024 to seek alignment with the FDA on the regulatory submission for OCS 01 for the treatment of post-operative inflammation and pain
  • 27 Aug 2024 Oculis Pharma plans to submit a New Drug Application (NDA) in Q1 of 2025
  • 27 Aug 2024 Oculis completes a Phase-III OPTIMIZE-1 clinical trials in Postoperative pain and Postoperative inflammation in USA (Ophthalmic) (NCT05147233)

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