{
 "query": "bimatoprost",
 "ingredient": "bimatoprost",
 "slug": "bimatoprost",
 "rxcui": "283810",
 "brands": [
  "Lumigan",
  "Durysta",
  "Latisse",
  "Zolymbus"
 ],
 "names": [
  "bimatoprost"
 ],
 "classes": [
  {
   "id": "S01EE",
   "name": "Prostaglandin analogues"
  }
 ],
 "alternatives": [
  "latanoprost",
  "latanoprostene bunod",
  "tafluprost",
  "travoprost",
  "unoprostone"
 ],
 "label": {
  "route_mode": "OPHTHALMIC",
  "route_counts": {
   "OPHTHALMIC": 19,
   "INTRACAMERAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Bimatoprost ophthalmic solution, for topical ophthalmic use is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.",
  "contraindications": "Bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [ see Adverse Reactions 6.2) ]. Hypersensitivity",
  "warnings_and_cautions": "Concurrent administration of Bimatoprost ophthalmic solution, for topical ophthalmic use and intraocular pressure (IOP)-lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their IOP. ( 5.1 ) Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. ( 5.2, 5.3 ) 5.1 Effects on Intraocular Pressure Bimatoprost ophthalmic solution (LUMIGAN \u00ae ) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, bimatoprost ophthalmic solution 0.03% lowered IOP, however, the magnitude of the reduction was not cause for clinical concern. In ocular hypertension studies with LUMIGAN \u00ae , it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect. In patients using LUMIGAN \u00ae or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of bimatoprost ophthalmic solution 0.03% may interfere with the desired reduc...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described elsewhere in the labeling: Effects on Intraocular Pressure [see Warnings and Precautions (5.1)] Iris Pigmentation [see Warnings and Precautions (5.2)] Lid Pigmentation [see Warnings and Precautions (5.3)] Hair Growth Outside the Treatment Area [see Warnings and Precautions (5.4)] Intraocular Inflammation [see Warnings and Precautions (5.5)] Macular Edema [see Warnings and Precautions (5.6)] Hypersensitivity [see Contraindications (4)] Most common adverse reactions (incidence approximately 3% to 4%) are eye pruritus, conjunctival hyperemia, and skin hyperpigmentation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following information is based on clinical trial results from a multicenter, double-masked, randomized, vehicle-controlled, parallel...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information) Nightly Application Inform patients that bimatoprost ophthalmic solution, 0.03% should be applied every night using only the accompanying sterile applicators. They should start by ensuring their face is clean, all makeup is removed, and their contact lenses removed (if applicable). Then, carefully place one drop of bimatoprost ophthalmic solution, 0.03% on the disposable sterile applicator and brush cautiously along the skin of the upper eyelid margin at the base of the eyelashes. If any bimatoprost ophthalmic solution, 0.03% gets into the eye proper, it will not cause harm. The eye should not be rinsed. Additional applications of bimatoprost ophthalmic solution, 0.03% will not increase the growth of eyelashes. Inform patients not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material. The onset of effect is gradual but is not significant in the majority of patients until 2 months. Counsel patients that the effect is not permanent and can be expected to gradually return to the original level upon discontinuat...",
  "spl_medguide": "",
  "clinical_studies": "Bimatoprost ophthalmic solution, 0.03% was evaluated for its effect on overall eyelash prominence in a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The primary efficacy endpoint in this study was an increase in overall eyelash prominence as measured by at least a 1-grade increase on the 4-point Global Eyelash Assessment (GEA) scale, from baseline to the end of the treatment period (week 16). Bimatoprost ophthalmic solution, 0.03% was more effective than vehicle as measured by the GEA score, with statistically significant differences seen at 8-week, 12-week, and 16-week ( primary endpoint ) treatment durations. Table 2 Number (%) of subjects with at least a 1-grade increase from baseline in Global Eyelash Assessment (Primary Efficacy Endpoint \u2013 Week 16) Week Bimatoprost ophthalmic solution, 0.03% N=137 N (%) Vehicle N= 141 N (%) 1 7 (5%) 3 (2%) 4 20 (15%) 11 (8%) 8 69 (50%) 21 (15%) 12 95 (69%) 28 (20%) 16 107 (78%) 26 (18%) 20 103 (79%) 27 (21%) In this study, patients were also evaluated for the effect of bimatoprost ophthalmic solution, 0.03% on the length, thickness and darkness of their eye...",
  "brand_name": "bimatoprost",
  "manufacturer": "Alembic Pharmaceuticals Limited",
  "application_number": "ANDA210515",
  "pharm_class_epc": [
   "Prostaglandin Analog [EPC]"
  ],
  "route": [
   "OPHTHALMIC"
  ],
  "effective_time": "20230719",
  "set_id": "2b4107e4-c108-4ed5-b7e8-253b74f2ff25",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 22681,
  "serious": 6232,
  "death": 659,
  "hospitalization": 2476,
  "primary_suspect": 22665,
  "top_reactions": [
   [
    "Drug Ineffective",
    3534
   ],
   [
    "Treatment Failure",
    3075
   ],
   [
    "Ocular Hyperaemia",
    1628
   ],
   [
    "Eye Irritation",
    1428
   ],
   [
    "Eye Pruritus",
    879
   ],
   [
    "Madarosis",
    871
   ],
   [
    "Hypersensitivity",
    794
   ],
   [
    "Eye Pain",
    780
   ],
   [
    "Off Label Use",
    693
   ],
   [
    "Intraocular Pressure Increased",
    611
   ],
   [
    "Erythema Of Eyelid",
    609
   ],
   [
    "Vision Blurred",
    598
   ],
   [
    "Wrong Technique In Product Usage Process",
    589
   ],
   [
    "Fatigue",
    584
   ],
   [
    "Headache",
    513
   ]
  ],
  "by_year": {
   "2019": 1768,
   "2020": 4440,
   "2021": 2504,
   "2022": 1106,
   "2023": 1297,
   "2024": 949,
   "2025": 948,
   "2026": 494
  },
  "by_year_primary": {
   "2019": 1768,
   "2020": 4440,
   "2021": 2504,
   "2022": 1097,
   "2023": 1295,
   "2024": 948,
   "2025": 947,
   "2026": 492
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20191017",
   "reason": "Labeling: Incorrect or missing package insert.",
   "firm": "Sandoz Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20171019",
   "reason": "Failed Impurities/Degradation Specifications.",
   "firm": "Allergan Sales, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20170316",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "Allergan Sales, LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 25,
  "nda": 5,
  "anda": 15,
  "first_approval": "20010316",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 22,
  "labeling_recent": 4,
  "sponsors": [
   "ABBVIE",
   "ALEMBIC",
   "AMNEAL",
   "APOTEX",
   "APOTEX INC",
   "EUGIA PHARMA",
   "GLAND",
   "GLAND PHARMA LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/16/2001"
 },
 "trials": {
  "total": 176,
  "completed": 141,
  "terminated": 9,
  "with_results": 92,
  "industry": 132,
  "phase3": 40,
  "results_share": 0.6524822695035462,
  "terminated_share": 0.05113636363636364
 },
 "pubmed": {
  "rct": 146,
  "meta": 3,
  "recent_rct": 24,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 2249158.0700000003,
  "records": 40901,
  "by_name": [
   [
    "Durysta",
    1458282.29
   ],
   [
    "Lumigan",
    783789.41
   ],
   [
    "Latisse",
    7086.37
   ]
  ],
  "names_checked": [
   "bimatoprost",
   "Lumigan",
   "Durysta",
   "Latisse",
   "Zolymbus"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1476293,
  "beneficiaries": 357398,
  "spend": 655739802.46,
  "by_brand": [
   {
    "brand": "Lumigan",
    "claims": 1407999,
    "per_claim": 459.66602969,
    "is_generic": false
   },
   {
    "brand": "Bimatoprost",
    "claims": 67911,
    "per_claim": 105.96836021,
    "is_generic": true
   },
   {
    "brand": "Durysta",
    "claims": 383,
    "per_claim": 3483.2245692,
    "is_generic": false
   }
  ],
  "per_claim": 444.17998490814495
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2387,
  "fills": 1476293,
  "per_million": 1616.887704541036,
  "ratio": 0.5839353720043723,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,617 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 47,
   "letter": "F",
   "why": [
    "146 randomized trials and 3 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 3 Class III across 15 generic makers (-1)",
    "4 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $2,249,158 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (15 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are treatment failure, ocular hyperaemia, eye irritation. How would we recognize and handle those?",
  "Why this one over latanoprost, latanoprostene bunod, tafluprost? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}