Lifitegrast
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| Clinical data | |
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| Trade names | Xiidra |
| Other names | SAR-1118 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a616039 |
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| Routes of administration | Eye drops |
| ATC code | |
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| CompTox Dashboard (EPA) | |
| ECHA InfoCard | 100.245.695 |
| Chemical and physical data | |
| Formula | C29H24Cl2N2O7S |
| Molar mass | 615.48 g·mol−1 |
| 3D model (JSmol) | |
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Lifitegrast, sold under the brand name Xiidra (/ˈzaɪdrə/[2]), is a medication for the treatment of signs and symptoms of dry eye, a syndrome called keratoconjunctivitis sicca. Lifitegrast reduces inflammation by inhibiting inflammatory cell binding.[3] It is often used in conjunction with ciclosporin (Ikervis, Restasis, or Cequa) for dry eye treatment including meibomian gland dysfunction and inflammatory dry eye.
Adverse effects
[edit]Common side effects in clinical trials were eye irritation, discomfort, blurred vision, and dysgeusia (a distortion of the sense of taste).[4]
Pharmacology
[edit]Lifitegrast is supplied as an eye drop.
Mechanism of action
[edit]Lifitegrast inhibits an integrin, lymphocyte function-associated antigen 1 (LFA-1), from binding to intercellular adhesion molecule 1 (ICAM-1). This mechanism down-regulates inflammation mediated by T lymphocytes.[3][5]
History
[edit]Lifitegrast was initially designed by Sunesis and developed by SARcode Bioscience[6] which was acquired by Shire in 2013,[7] which submitted a new drug application to the US Food and Drug Administration (FDA) in March 2015. The FDA granted Shire a priority review a month later, and requested additional clinical data, which were supplied in January 2016; approval was granted on 11 July 2016.[8][9] Lifitegrast was approved by Health Canada in January 2018, and available in Canadian pharmacies as of March 2018.
Shire was acquired by Takeda Pharmaceutical Company in late 2018.[10] In May 2019 Novartis reached an agreement to purchase the assets associated with Lifitegrast. Novartis will pay Takeda an upfront payment of $3.4 billion, while the latter drugmaker is eligible for milestone payments of as much as $1.9 billion. Novartis noted that the drug amassed approximately $400 million in revenue in 2018.[11] In 2023, Novartis sold the assets to Bausch + Lomb for $1.75 billion and eligible for an additional $750 million in payments linked to future sales for Xiidra as well as two pipeline assets.[12][13]
References
[edit]- ^ "Eye health". Health Canada. 9 May 2018. Retrieved 13 April 2024.
- ^ "Patient information: Xiidra® (ZYE-druh) (lifitegrast ophthalmic solution) 5% for topical ophthalmic use" (PDF). Novartis. June 2020. Retrieved 5 February 2021.
- ^ a b Tauber J, Karpecki P, Latkany R, Luchs J, Martel J, Sall K, et al. (December 2015). "Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study". Ophthalmology. 122 (12): 2423–2431. doi:10.1016/j.ophtha.2015.08.001. PMID 26365210.
- ^ Drugs.com: Patient information for xiidra.
- ^ Murphy CJ, Bentley E, Miller PE, McIntyre K, Leatherberry G, Dubielzig R, et al. (May 2011). "The pharmacologic assessment of a novel lymphocyte function-associated antigen-1 antagonist (SAR 1118) for the treatment of keratoconjunctivitis sicca in dogs". Investigative Ophthalmology & Visual Science. 52 (6): 3174–3180. doi:10.1167/iovs.09-5078. PMID 21330663.
- ^ Semba CP, Gadek TR (2016). "Development of lifitegrast: a novel T-cell inhibitor for the treatment of dry eye disease". Clinical Ophthalmology. 10: 1083–1094. doi:10.2147/OPTH.S110557. PMC 4910612. PMID 27354762.
- ^ "Shire To Acquire Sarcode Bioscience, Expands Presence In Ophthalmology". Shire. 25 March 2013.
- ^ "FDA Approves Shire's Xiidra". 11 July 2016.
- ^ "Xiidra (lifitegrast) FDA Approval History". Drugs.com.
- ^ "Takeda Completes Acquisition of Shire, Becoming a Global, Values-based, R&D-Driven Biopharmaceutical Leader". Takeda. 8 January 2019.
- ^ "Novartis to acquire Xiidra, expanding front-of-eye portfolio and strengthening leadership in eye care". Novartis (Press release). 9 May 2019.
- ^ Pfanner E, Kresge N (30 June 2023). "Novartis Sells Eye Drugs to Bausch + Lomb for Up to $2.5 Billion". Bloomberg News.
- ^ Furnas D (4 October 2023). "Bausch + Lomb closes $2.5B XIIDRA acquisition". NJBIZ.