NDAIMPLANTATIONIMPLANTPriority Review
Approved
Mar 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
VITRASERT (ganciclovir) by Bausch + Lomb is 12. Approved for cytomegalovirus retinitis, cytomegalovirus infection. First approved in 1996.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VITRASERT is a ganciclovir-releasing implant approved in 1996 for the treatment of cytomegalovirus (CMV) retinitis and CMV infection in immunocompromised patients. The drug works as a DNA polymerase inhibitor with selective activity against CMV, delivered via surgical implantation to achieve sustained local and systemic exposure. Ganciclovir exhibits linear pharmacokinetics with primarily renal elimination and achieves cerebrospinal fluid penetration of 24-70% of plasma concentrations.
LOE Approaching
Product approaching loss of exclusivity with limited current job market activity; team focus shifting toward lifecycle management and transition planning.
Mechanism of Action
12.1 Mechanism of Action Ganciclovir is an antiviral drug with activity against CMV [see ]. 12.3 Pharmacokinetics Absorption At the end of a one hour intravenous infusion of 5 mg/kg ganciclovir, total AUC ranged between 22.1 ± 3.2 (n = 16) and 26.8 ± 6.1 mcg·hr/mL (n = 16) and C max ranged between…
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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.