NDAOPHTHALMICSOLUTION/DROPS
Approved
Apr 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
5/8 — Partial
PROLENSA (bromfenac sodium) by Bausch + Lomb is anti-inflammatory drug (nsaid) that has anti-inflammatory activity. First approved in 2013.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROLENSA is a topical ophthalmic NSAID (bromfenac sodium) approved in 2013 for post-operative inflammation and pain following cataract surgery. It works by inhibiting COX-1 and COX-2 enzymes to block prostaglandin synthesis, which reduces intraocular inflammation, vasodilation, and increased vascular permeability. The drug is administered as eye drops directly to the ocular surface.
$95MPart D
PeakStable
7.4 years to LOEPeak revenue positioning with $95M annual Part D spending indicates a mature, stable franchise requiring focused commercialization and field presence maintenance.
Mechanism of Action
anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase (COX) 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period
Started Aug 2021
77 enrolled
Vein OcclusionMacular Degeneration Choroidal NeovascularizationMacular Edema+1 more
Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial
Started Oct 2013
57 enrolled
Treatment of Ocular Inflammation Associated With Cataract Surgery
Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery
Started Apr 2013
50 enrolled
CataractRetinal EdemaInflammation
Worked on PROLENSA at Bausch + Lomb? Share your interview experience or compensation data (+7 days Pro)
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.