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Data updated: Mar 10, 2026

DEXYCU KIT

DEXAMETHASONE Corticosteroid Hormone Receptor Agonists
Oncology Approved 2018-02-09
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2018-02-09
Routes
INTRAOCULAR
Dosage Forms
SUSPENSION

Companies

EYEPOINT PHARMS
Active Ingredient: DEXAMETHASONE

DEXYCU KIT Approval History

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What DEXYCU KIT Treats

10 indications

DEXYCU KIT is approved for 10 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Asthma
  • Atopic Dermatitis
  • Contact Dermatitis
  • Drug Hypersensitivity
  • Allergic Rhinitis
  • Serum Sickness
  • Dermatitis Herpetiformis
  • Exfoliative Erythroderma
Source: FDA Label

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Key Completed Trials

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DEXYCU KIT FDA Label Details

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Indications & Usage

FDA Label (PDF)

A l l ergic States: Control of severe or incapacitating a llergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunctio...

DEXYCU KIT Patents & Exclusivity

Latest Patent: Jun 2039

Patents (5 active)

US11097061 Expires Jun 23, 2039
US10022502 Expires Jun 22, 2034
US10028965 Expires May 23, 2034
US10159683 Expires May 23, 2034
US10799642 Expires May 11, 2032
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA208912 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.