NDAOPHTHALMICSOLUTION/DROPS
Approved
Apr 2016
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
19
Data completeness
6/8 — Strong
BROMSITE (bromfenac) by Fosun Pharma is anti-inflammatory drug (nsaid) that has anti-inflammatory activity. First approved in 2016.
Drug data last refreshed 33m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BROMSITE is a topical ophthalmic NSAID solution containing bromfenac that reduces intraocular inflammation by inhibiting prostaglandin synthesis through COX-1/COX-2 blockade. It is indicated for postoperative ocular inflammation and pain following cataract surgery. The drug works by suppressing prostaglandin-mediated disruption of the blood-aqueous barrier, vasodilation, and elevated intraocular pressure.
$4MPart D
LOE Approaching2.3 years to LOEWith only ~$4M in annual Part D spending and 2.5 years to LOE (March 2029), this is a niche, consolidating product likely managed by a small specialized team focused on transition planning.
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 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 (19)
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
Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Started May 2011
440 enrolled
PainInflammationCataract
Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%
Started Nov 2010
23 enrolled
InflammationPseudophakia
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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.