NDAINTRAVITREALINJECTABLEPriority Review
Approved
Sep 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Macugen (pegaptanib sodium) is an intravitreal injectable aptamer approved in 2004 for neovascular age-related macular degeneration (AMD). It is an anti-VEGF agent that binds selectively to vascular endothelial growth factor (VEGF165), reducing abnormal blood vessel growth in the retina. The drug represents an early entry into the anti-VEGF class for ocular indications.
LOE Approaching
As a product approaching loss of exclusivity with moderate competitive pressure (30/100), the brand team is likely focused on managed decline, customer retention, and transition planning rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Started Jan 2011
46 enrolled
Anti- VGF InhibitorDiabetic Macular EdemaDiabetic Retinopathy
Intravitreal Macugen for Ischaemic Diabetic Macular Oedema
Started Jan 2011
30 enrolled
Diabetic Macular Oedema
A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema
Started May 2010
243 enrolled
Macular EdemaDiabetic MellitusRetinal Disease
Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium
Started Apr 2010
131 enrolled
Age-Related Macular DegenerationRetinal Vein OcclusionDiabetic Macular Edema
Prospective, Randomized, Open Label, Phase II Study to Assess Efficacy and Safety of Macugen® (Pegaptanib 0.3 mg Intravitreal Injections) Plus Panretinal Photocoagulation and PRP (Monotherapy) in the Treatment With High Risk PDR.
Started Mar 2010
22 enrolled
High Risk Proliferative Diabetic RetinopathyDiabetes Mellitus Type IDiabetes Mellitus Type II
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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.