{
 "query": "travoprost",
 "ingredient": "travoprost",
 "slug": "travoprost",
 "rxcui": "283809",
 "brands": [
  "iDose",
  "Travatan"
 ],
 "names": [
  "travoprost"
 ],
 "classes": [
  {
   "id": "S01EE",
   "name": "Prostaglandin analogues"
  }
 ],
 "alternatives": [
  "bimatoprost",
  "latanoprost",
  "latanoprostene bunod",
  "tafluprost",
  "unoprostone"
 ],
 "label": {
  "route_mode": "OPHTHALMIC",
  "route_counts": {
   "OPHTHALMIC": 14,
   "INTRACAMERAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Travoprost ophthalmic solution (ionic buffered solution) is a prostaglandin analog indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "\u2022 Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid), and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1 ) \u2022 Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 ) 5.1 Pigmentation Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation aroun...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reaction (30% to 50%) is conjunctival hyperemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 most common adverse reaction observed in controlled clinical trials with travoprost ophthalmic solution 0.004% was ocular hyperemia, which was reported in 30% to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5% to 10% in these clinical trials included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. Ocular adverse reactions reported at an incidence of 1% to 4% in clinical trials with travoprost ophthalmic solution 0.004% included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloratio...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Potential for Pigmentation Advise the patient about the potential for increased brown pigmentation of the iris, which may be permanent. Inform the patient about the possibility of eyelid skin darkening, which may be reversible after discontinuation of travoprost ophthalmic solution 0.004% [see Warnings and Precautions (5.1) ] . Potential for Eyelash Changes Inform the patient about the possibility of eyelash and vellus hair changes in the treated eye during treatment with travoprost ophthalmic solution 0.004%. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment [see Warnings and Precautions (5.2) ] . Handling the Container Instruct the patient to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions (5.6)...",
  "spl_medguide": "",
  "clinical_studies": "In clinical studies, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 25 to 27 mmHg who were treated with travoprost ophthalmic solution 0.004% dosed once daily in the evening, demonstrated 7 to 8 mmHg reductions in IOP. In subgroup analyses of these studies, mean IOP reduction in black patients was up to 1.8 mmHg greater than in non-black patients. It is not known at this time whether this difference is attributed to race or to heavily pigmented irides. In a multi-center, randomized, controlled trial, patients with mean baseline IOP of 24 to 26 mmHg on timolol maleate ophthalmic solution 0.5% twice daily who were treated with travoprost ophthalmic solution 0.004% dosed daily adjunctively to timolol maleate ophthalmic solution 0.5% twice daily demonstrated 6 to 7 mmHg reductions in IOP.",
  "brand_name": "Travoprost Ophthalmic Solution, 0.004%",
  "manufacturer": "Mylan Pharmaceuticals Inc.",
  "application_number": "ANDA205050",
  "pharm_class_epc": [
   "Prostaglandin Analog [EPC]"
  ],
  "route": [
   "OPHTHALMIC"
  ],
  "effective_time": "20260115",
  "set_id": "00dc284f-fd96-423b-bb8f-b90ee13439bf",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 11465,
  "serious": 4636,
  "death": 550,
  "hospitalization": 1604,
  "primary_suspect": 11460,
  "top_reactions": [
   [
    "Treatment Failure",
    2391
   ],
   [
    "Drug Ineffective",
    741
   ],
   [
    "Ocular Hyperaemia",
    593
   ],
   [
    "Eye Irritation",
    589
   ],
   [
    "Intraocular Pressure Increased",
    444
   ],
   [
    "Eye Pain",
    427
   ],
   [
    "Glaucoma",
    380
   ],
   [
    "Hypersensitivity",
    372
   ],
   [
    "Fatigue",
    358
   ],
   [
    "Dyspnoea",
    351
   ],
   [
    "Visual Impairment",
    351
   ],
   [
    "Dizziness",
    306
   ],
   [
    "Headache",
    303
   ],
   [
    "Vision Blurred",
    302
   ],
   [
    "Death",
    296
   ]
  ],
  "by_year": {
   "2019": 1129,
   "2020": 3373,
   "2021": 651,
   "2022": 446,
   "2023": 352,
   "2024": 319,
   "2025": 406,
   "2026": 234
  },
  "by_year_primary": {
   "2019": 1129,
   "2020": 3373,
   "2021": 651,
   "2022": 445,
   "2023": 350,
   "2024": 319,
   "2025": 405,
   "2026": 233
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20230525",
   "reason": "Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.",
   "firm": "Golden State Medical Supply Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 14,
  "nda": 4,
  "anda": 9,
  "first_approval": "20010316",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 11,
  "labeling_recent": 3,
  "sponsors": [
   "ALCON PHARMS LTD",
   "ALEMBIC",
   "APOTEX",
   "CHARTWELL RX",
   "GLAND",
   "GLAUKOS",
   "LUPIN",
   "MICRO LABS"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/16/2001"
 },
 "trials": {
  "total": 158,
  "completed": 124,
  "terminated": 18,
  "with_results": 57,
  "industry": 125,
  "phase3": 36,
  "results_share": 0.4596774193548387,
  "terminated_share": 0.11392405063291139
 },
 "pubmed": {
  "rct": 101,
  "meta": 2,
  "recent_rct": 6,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 1404658.84,
  "records": 4091,
  "by_name": [
   [
    "iDose",
    1404658.84
   ]
  ],
  "names_checked": [
   "travoprost",
   "iDose",
   "Travatan"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 497738,
  "beneficiaries": 122995,
  "spend": 85713207.13,
  "by_brand": [
   {
    "brand": "Travoprost",
    "claims": 476526,
    "per_claim": 157.63681381,
    "is_generic": true
   },
   {
    "brand": "Travatan Z",
    "claims": 21212,
    "per_claim": 499.48928861,
    "is_generic": false
   }
  ],
  "per_claim": 172.20547181448873
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 957,
  "fills": 497738,
  "per_million": 1922.698287050617,
  "ratio": 0.6943781787367639,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,923 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 40,
   "letter": "F",
   "why": [
    "101 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 46% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $1,404,659 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 (9 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "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 bimatoprost, latanoprost, latanoprostene bunod? 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.)"
 ]
}