NDAOPHTHALMICINSERT
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
DEXTENZA (dexamethasone) by Ocular Instruments is corticosteroid hormone receptor agonists [moa]. Approved for acute otitis externa. First approved in 2018.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEXTENZA is a dexamethasone ophthalmic insert approved for acute otitis externa, delivering corticosteroid anti-inflammatory therapy directly to the ear canal. It is a small-molecule corticosteroid hormone receptor agonist that suppresses inflammation by inhibiting multiple inflammatory cytokines, reducing edema, fibrin deposition, and inflammatory cell migration. The insert formulation provides sustained local delivery with minimal systemic absorption.
Peak15.0 years to LOE
Product is in peak commercial phase with established market presence; team size and investment likely stable to growing.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
Indications (1)
Clinical Trials (20)
HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Started Oct 2026
42 enrolled
Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) RecurrentLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory+2 more
Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
Started Jul 2026
62 enrolled
Relapse Multiple MyelomaRefractory Multiple Myeloma
A Non-interventional Study of Melphalan Flufenamide (Melflufen) (Pepaxti®) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma (R/RMM)
Started May 2026
50 enrolled
Multiple Myeloma
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Started May 2026
500 enrolled
Multiple Myeloma
Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma
Started May 2026
380 enrolled
Multiple Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.