{
 "query": "lifitegrast",
 "ingredient": "lifitegrast",
 "slug": "lifitegrast",
 "rxcui": "1801820",
 "brands": [
  "Xiidra"
 ],
 "names": [
  "lifitegrast"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "OPHTHALMIC",
  "route_counts": {
   "OPHTHALMIC": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "Xiidra \u00ae (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). ( 1 )",
  "contraindications": "Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [see Adverse Reactions (6.2)] . Hypersensitivity. ( 4 )",
  "warnings_and_cautions": "",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4)] The most common adverse reactions (incidence 5%-25%) following the use of Xiidra were instillation-site irritation, dysgeusia, and decreased visual acuity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 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. In five clinical trials of DED conducted with lifitegrast ophthalmic solution, 1401 patients received at least one dose of lifitegrast (1287 of which received lifitegrast 5%). The majority of patients (84%) had less than or equal to 3 months of treatment exposure. One hundred-seventy patients were exposed to lifitegrast for approximately 12 months. The majority of the treated patients were female (77%). The most common adverse reactions reported in 5%-25% of patie...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Handling the Single-use Container Advise patients not to touch the tip of the single-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution. Use With Contact Lenses Advise patients that contact lenses should be removed prior to administration of Xiidra and can be reinserted 15 minutes after administration [see Dosage and Administration (2)] . Administration Advise patients that the solution from one single-use container is to be used immediately after opening. It can be used to dose both eyes. The single-use container, including any remaining contents should be discarded immediately after administration [see Dosage and Administration (2)] . Storage Information Instruct patients to store single-use containers in the original foil pouch until ready to use [see How Supplied/Storage and Handling (16)] . Distributed by: Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936 T2020-87",
  "spl_medguide": "",
  "clinical_studies": "The safety and efficacy of lifitegrast for the treatment of DED were assessed in a total of 1181 patients (1067 of which received lifitegrast 5%) in four 12-week, randomized, multi-center, double-masked, vehicle-controlled studies. Patients were randomized to Xiidra or vehicle (placebo) in a 1:1 ratio and dosed twice a day. Use of artificial tears was not allowed during the studies. The mean age was 59 years (range, 19-97 years). The majority of patients were female (76%). Enrollment criteria included minimal signs (i.e., Corneal Fluorescein Staining and non-anesthetized Schirmer Tear Test) and symptoms (i.e., Eye Dryness Score (EDS) and Ocular Discomfort Score) severity scores at baseline. Effects on Symptoms of Dry Eye Disease Eye dryness score was rated by patients using a visual analogue scale (0 = no discomfort, 100 = maximal discomfort) at each study visit. The average baseline EDS was between 40 and 70. A larger reduction in EDS favoring Xiidra was observed in all studies at Day 42 and Day 84 (see Figure 1). Figure 1: Mean Change (SD) From Baseline and Treatment Difference (Xiidra \u2013 Vehicle) in Eye Dryness Score in 12-Week Studies in Patients With Dry Eye Disease [1] Based o...",
  "brand_name": "Xiidra",
  "manufacturer": "Novartis Pharmaceuticals Corporation",
  "application_number": "NDA208073",
  "pharm_class_epc": [
   "Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]"
  ],
  "route": [
   "OPHTHALMIC"
  ],
  "effective_time": "20250818",
  "set_id": "8589d376-ac10-4ddb-9c53-2e0c8d5675c4",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 16247,
  "serious": 2916,
  "death": 293,
  "hospitalization": 659,
  "primary_suspect": 16241,
  "top_reactions": [
   [
    "Eye Irritation",
    2742
   ],
   [
    "Vision Blurred",
    2634
   ],
   [
    "Drug Ineffective",
    1601
   ],
   [
    "Eye Pain",
    1419
   ],
   [
    "Instillation Site Pain",
    1283
   ],
   [
    "Dry Eye",
    1167
   ],
   [
    "Dysgeusia",
    1104
   ],
   [
    "Instillation Site Reaction",
    1019
   ],
   [
    "Ocular Hyperaemia",
    692
   ],
   [
    "Lacrimation Increased",
    628
   ],
   [
    "Headache",
    619
   ],
   [
    "Visual Impairment",
    578
   ],
   [
    "Product Dose Omission Issue",
    448
   ],
   [
    "Eye Pruritus",
    436
   ],
   [
    "Eye Discharge",
    393
   ]
  ],
  "by_year": {
   "2019": 1190,
   "2020": 1979,
   "2021": 2129,
   "2022": 2489,
   "2023": 1921,
   "2024": 1097,
   "2025": 985,
   "2026": 438
  },
  "by_year_primary": {
   "2019": 1189,
   "2020": 1979,
   "2021": 2129,
   "2022": 2484,
   "2023": 1921,
   "2024": 1097,
   "2025": 985,
   "2026": 438
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20220510",
   "reason": "Failed Impurities/Degradation Specifications.",
   "firm": "Novartis Pharmaceuticals Corporation",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20220510",
   "reason": "Failed Impurities/Degradation Specifications.",
   "firm": "Novartis Pharmaceuticals Corporation",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 5,
  "nda": 1,
  "anda": 3,
  "first_approval": "20160711",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 2,
  "labeling_recent": 0,
  "sponsors": [
   "BAUSCH AND LOMB INC",
   "EUGIA PHARMA",
   "INGENUS PHARMS LLC",
   "MICRO LABS",
   "SUN PHARM INDS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/11/2016"
 },
 "trials": {
  "total": 39,
  "completed": 21,
  "terminated": 9,
  "with_results": 14,
  "industry": 30,
  "phase3": 6,
  "results_share": 0.6666666666666666,
  "terminated_share": 0.23076923076923078
 },
 "pubmed": {
  "rct": 8,
  "meta": 0,
  "recent_rct": 2,
  "cochrane": [
   {
    "pmid": "40539519",
    "title": "Topical lifitegrast therapy for dry eye disease",
    "year": "2025"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 683180.01,
  "records": 12339,
  "by_name": [
   [
    "Xiidra",
    683180.01
   ]
  ],
  "names_checked": [
   "lifitegrast",
   "Xiidra"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 477354,
  "beneficiaries": 166361,
  "spend": 505334180.32,
  "by_brand": [
   {
    "brand": "Xiidra",
    "claims": 477354,
    "per_claim": 1058.6151584,
    "is_generic": false
   }
  ],
  "per_claim": 1058.6151583939802
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2520,
  "fills": 477354,
  "per_million": 5279.101044507849,
  "ratio": 1.9065355148757175,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 94,
   "letter": "A",
   "why": [
    "5,279 FDA reports naming it as the suspect drug per million Medicare fills, 1.9x the median drug on this site (-6)",
    "Death share in reports is near or below the FAERS average (0.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 19,
   "letter": "F",
   "why": [
    "8 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "23% of registered trials were terminated, withdrawn, or suspended (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 98,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 2 Class III (-2)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $683,180 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (3 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are eye irritation, vision blurred, eye pain. How would we recognize and handle those?",
  "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.)"
 ]
}