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Daclizumab was used to treat adults with relapsing forms of [[multiple sclerosis]].<ref name=BLAapproval>FDA [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761029Orig1s000ltr.pdf BLA Approval letter] May 27, 2016</ref> It is administered subcutaneously.<ref name=2015rev>{{cite journal | vauthors = Lycke J | title = Monoclonal antibody therapies for the treatment of relapsing-remitting multiple sclerosis: differentiating mechanisms and clinical outcomes | journal = Therapeutic Advances in Neurological Disorders | volume = 8 | issue = 6 | pages = 274–93 | date = November 2015 | pmid = 26600872 | pmc = 4643868 | doi = 10.1177/1756285615605429 }}</ref>
Daclizumab was used to treat adults with relapsing forms of [[multiple sclerosis]].<ref name=BLAapproval>FDA [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761029Orig1s000ltr.pdf BLA Approval letter] May 27, 2016</ref> It is administered subcutaneously.<ref name=2015rev>{{cite journal | vauthors = Lycke J | title = Monoclonal antibody therapies for the treatment of relapsing-remitting multiple sclerosis: differentiating mechanisms and clinical outcomes | journal = Therapeutic Advances in Neurological Disorders | volume = 8 | issue = 6 | pages = 274–93 | date = November 2015 | pmid = 26600872 | pmc = 4643868 | doi = 10.1177/1756285615605429 }}</ref>


In clinical trials, decreases of 45% in annualized relapse rate have been reported, as well as a 41% reduction in the proportion of patients who relapsed, and a 54% reduction in the number of new lesions<ref name=2015rev/>. A 2013 [[Cochrane (organisation)|Cochrane]] [[systematic review]] concluded that there was insufficient evidence to determine the efficacy of daclizumab relative to placebo in people with [[Relapsing remitting MS|relapsing-remitting MS]] and, prior to its being discontinued, the need to investigate longer lengths of treatment and follow-up.<ref>{{Cite journal|last=Liu|first=Jia|last2=Wang|first2=Lu-Ning|last3=Zhan|first3=Siyan|last4=Xia|first4=Yinyin|date=2013-12-23|title=Daclizumab for relapsing remitting multiple sclerosis|journal=The Cochrane Database of Systematic Reviews|issue=12|pages=CD008127|doi=10.1002/14651858.CD008127.pub4|issn=1469-493X|pmid=24363032}}</ref>
In clinical trials, decreases of 45% in annualized relapse rate have been reported, as well as a 41% reduction in the proportion of patients who relapsed, and a 54% reduction in the number of new lesions<ref name=2015rev/>. A 2013 [[Cochrane (organisation)|Cochrane]] [[systematic review]] concluded that there was insufficient evidence to determine the efficacy of daclizumab relative to placebo in people with [[Relapsing remitting MS|relapsing-remitting MS]] and, prior to its being discontinued, the need to investigate longer lengths of treatment and follow-up.<ref>{{Cite journal|last1=Liu|first1=Jia|last2=Wang|first2=Lu-Ning|last3=Zhan|first3=Siyan|last4=Xia|first4=Yinyin|date=2013-12-23|title=Daclizumab for relapsing remitting multiple sclerosis|journal=The Cochrane Database of Systematic Reviews|issue=12|pages=CD008127|doi=10.1002/14651858.CD008127.pub4|issn=1469-493X|pmid=24363032}}</ref>


===Discontinued use===
===Discontinued use===
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In December 1997 daclizumab was approved by the FDA for use in preventing acute rejection of kidney transplants, in combination with ciclosporin and corticosteroids; it was the first humanized antibody approved anywhere in the world.<ref>Lawrence M. Fisher for The New York Times. December 12, 1997 [https://www.nytimes.com/1997/12/12/us/genetically-engineered-drug-approved-for-kidney-transplants.html Genetically Engineered Drug Approved for Kidney Transplants]</ref><ref name=PLfirst>Staff, The Pharma Letter. December 17, 1997. [http://www.thepharmaletter.com/article/roche-s-zenapax-gets-first-approval-for-transplants Roche's Zenapax Gets First Approval For Transplants]</ref> At launch, the average wholesale price for the drug was estimated to be $6,800 for five doses and it was estimated that annual sales would be between $100 million and $250 million within five years of the launch and it was thought that the drug's use would be expanded for use in other organ transplants.<ref name=PLfirst/> It was approved in Europe in 1999.<ref>Roche. March 04, 1999 [http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=7568 Roche Press Release: Zenapax (daclizumab), The First Humanized Monoclonal Antibody To Prevent Organ Rejection, Approved In The European Union]</ref>
In December 1997 daclizumab was approved by the FDA for use in preventing acute rejection of kidney transplants, in combination with ciclosporin and corticosteroids; it was the first humanized antibody approved anywhere in the world.<ref>Lawrence M. Fisher for The New York Times. December 12, 1997 [https://www.nytimes.com/1997/12/12/us/genetically-engineered-drug-approved-for-kidney-transplants.html Genetically Engineered Drug Approved for Kidney Transplants]</ref><ref name=PLfirst>Staff, The Pharma Letter. December 17, 1997. [http://www.thepharmaletter.com/article/roche-s-zenapax-gets-first-approval-for-transplants Roche's Zenapax Gets First Approval For Transplants]</ref> At launch, the average wholesale price for the drug was estimated to be $6,800 for five doses and it was estimated that annual sales would be between $100 million and $250 million within five years of the launch and it was thought that the drug's use would be expanded for use in other organ transplants.<ref name=PLfirst/> It was approved in Europe in 1999.<ref>Roche. March 04, 1999 [http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=7568 Roche Press Release: Zenapax (daclizumab), The First Humanized Monoclonal Antibody To Prevent Organ Rejection, Approved In The European Union]</ref>


PDL began clinical trials of daclizumab on its own, and in September 2004 after the drug had shown promise in a Phase II trial, PDL and Roche agreed to expand their relationship to include codevelopment of daclizumab for asthma and other respiratory conditions.<ref>Candace Hoffmann for First Word Pharma. September 16, 2004 [http://www.firstwordpharma.com/node/217798?tsid=17#axzz4AHJfVHyr Roche in new deal to co-development asthma drug]</ref> In August 2005, PDL and [[Biogen Idec]] agreed to collaborate to develop daclizumab in indications outside the fields of organ rejection and respiratory disease.<ref name="pmid16211058">{{cite journal | vauthors = Thiel KA | title = A very firm handshake: biotech's growing negotiating power | journal = Nature Biotechnology | volume = 23 | issue = 10 | pages = 1221–6 | date = October 2005 | pmid = 16211058 | doi = 10.1038/nbt1005-1221 }}</ref> In November 2005 Roche and PDL agreed to try to develop a formulation of daclizumab that would be useful as a [[subcutaneous injection]] for longterm maintenance in organ transplant.<ref>Staff, PharmaTimes. November 1, 2005 [http://www.pharmatimes.com/news/roche_inks_new_deal_for_transplant_drug_997651 Roche inks new deal for transplant drug]</ref> The next year Roche and PDL announced that the collaboration for all indications was ending,<ref>PharmaTimes November 23, 2006 [http://www.pharmatimes.com/news/roche_ducks_out_of_transplant_drug_alliance_995643 Roche ducks out of transplant drug alliance]</ref> and in 2009 it announced that it was discontinuing Zenapax worldwide "in view of available alternative treatments and the diminishing market demand" and "not due to any safety issue."<ref>[http://www.ema.europa.eu/humandocs/PDFs/EPAR/Zenapax/68376508en.pdf EMEA: Withdrawal of the marketing authorisation in the European Union]</ref><ref>Roche via the FDA [https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM194907.pdf Letter to Healthcare Professionals] September 2009</ref>
PDL began clinical trials of daclizumab on its own, and in September 2004 after the drug had shown promise in a Phase II trial, PDL and Roche agreed to expand their relationship to include codevelopment of daclizumab for asthma and other respiratory conditions.<ref>Candace Hoffmann for First Word Pharma. September 16, 2004 [http://www.firstwordpharma.com/node/217798?tsid=17#axzz4AHJfVHyr Roche in new deal to co-development asthma drug]</ref> In August 2005, PDL and [[Biogen Idec]] agreed to collaborate to develop daclizumab in indications outside the fields of organ rejection and respiratory disease.<ref name="pmid16211058">{{cite journal | vauthors = Thiel KA | title = A very firm handshake: biotech's growing negotiating power | journal = Nature Biotechnology | volume = 23 | issue = 10 | pages = 1221–6 | date = October 2005 | pmid = 16211058 | doi = 10.1038/nbt1005-1221 | s2cid = 19365410 }}</ref> In November 2005 Roche and PDL agreed to try to develop a formulation of daclizumab that would be useful as a [[subcutaneous injection]] for longterm maintenance in organ transplant.<ref>Staff, PharmaTimes. November 1, 2005 [http://www.pharmatimes.com/news/roche_inks_new_deal_for_transplant_drug_997651 Roche inks new deal for transplant drug]</ref> The next year Roche and PDL announced that the collaboration for all indications was ending,<ref>PharmaTimes November 23, 2006 [http://www.pharmatimes.com/news/roche_ducks_out_of_transplant_drug_alliance_995643 Roche ducks out of transplant drug alliance]</ref> and in 2009 it announced that it was discontinuing Zenapax worldwide "in view of available alternative treatments and the diminishing market demand" and "not due to any safety issue."<ref>[http://www.ema.europa.eu/humandocs/PDFs/EPAR/Zenapax/68376508en.pdf EMEA: Withdrawal of the marketing authorisation in the European Union]</ref><ref>Roche via the FDA [https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM194907.pdf Letter to Healthcare Professionals] September 2009</ref>


in 2008 PDL spun out its active development programs into a company called Facet Biotech and development of daclizumab for multiple sclerosis and the partnership with Biogen was included in that spinout.<ref>John Carroll for FierceBiotech. 2009 [http://www.fiercebiotech.com/special-report/emerging-drug-developer-facet-biotech Emerging Drug Developer: Facet Biotech]</ref><ref name=2008sec>[https://www.sec.gov/Archives/edgar/data/882104/000110465908078237/a08-30875_18k.htm PDL BioPharma, Inc. Form 8-K] December 17, 2008</ref> In 2009 Biogen attempted a hostile buy out of Facet for $350M;<ref>Luke Timmerman for Xconomy. September 4, 2009 [http://www.xconomy.com/boston/2009/09/04/biogen-idec-makes-hostile-350m-takeover-bid-for-facet-biotech/ Biogen Idec Makes Hostile $350M Takeover Bid for Facet Biotech]</ref> Facet rejected that offer and was purchased by [[Abbvie]] for $450 million in cash the next year.<ref>Staff, New York Times Dealbook. March 9, 2010. [https://dealbook.nytimes.com/2010/03/09/abbott-to-buy-facet-biotech-for-67-premium/ Abbott to Buy Facet Biotech for 67% Premium]</ref> In May 2016 the FDA approved daclizumab for the treatment of relapsing multiple sclerosis in adults in 2016 under the trade name Zinbryta, with requirements for postmarketing studies and to submit a formal Risk Evaluation and Mitigation Strategy.<ref name=BLAapproval/><ref>[https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504000.htm FDA News Release: FDA approves Zinbryta to treat multiple sclerosis] May 27, 2016</ref>
in 2008 PDL spun out its active development programs into a company called Facet Biotech and development of daclizumab for multiple sclerosis and the partnership with Biogen was included in that spinout.<ref>John Carroll for FierceBiotech. 2009 [http://www.fiercebiotech.com/special-report/emerging-drug-developer-facet-biotech Emerging Drug Developer: Facet Biotech]</ref><ref name=2008sec>[https://www.sec.gov/Archives/edgar/data/882104/000110465908078237/a08-30875_18k.htm PDL BioPharma, Inc. Form 8-K] December 17, 2008</ref> In 2009 Biogen attempted a hostile buy out of Facet for $350M;<ref>Luke Timmerman for Xconomy. September 4, 2009 [http://www.xconomy.com/boston/2009/09/04/biogen-idec-makes-hostile-350m-takeover-bid-for-facet-biotech/ Biogen Idec Makes Hostile $350M Takeover Bid for Facet Biotech]</ref> Facet rejected that offer and was purchased by [[Abbvie]] for $450 million in cash the next year.<ref>Staff, New York Times Dealbook. March 9, 2010. [https://dealbook.nytimes.com/2010/03/09/abbott-to-buy-facet-biotech-for-67-premium/ Abbott to Buy Facet Biotech for 67% Premium]</ref> In May 2016 the FDA approved daclizumab for the treatment of relapsing multiple sclerosis in adults in 2016 under the trade name Zinbryta, with requirements for postmarketing studies and to submit a formal Risk Evaluation and Mitigation Strategy.<ref name=BLAapproval/><ref>[https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504000.htm FDA News Release: FDA approves Zinbryta to treat multiple sclerosis] May 27, 2016</ref>

Revision as of 03:42, 12 September 2020

Daclizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD25
Clinical data
Trade namesZinbryta (multiple sclerosis)
Zenapax (acute transplant rejection, discontinued in 2009)
AHFS/Drugs.comzinbryta
License data
Pregnancy
category
  • AU: B3
Routes of
administration		Subcutaneous injection (MS)
Intravenous (transplant rejection, discontinued)
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only / Withdrawn[1]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability90%
MetabolismProteases
Elimination half-life21 days (11–38 days)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6332H9808N1678O1989S42
Molar mass142612.39 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Daclizumab (trade name Zinbryta) is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T-cells.

In March 2018, it was voluntarily withdrawn from the market by Biogen and Abbvie after reports of encephalitis in Europe.[2][3][1]

Medical uses

Daclizumab was used to treat adults with relapsing forms of multiple sclerosis.[4] It is administered subcutaneously.[5]

In clinical trials, decreases of 45% in annualized relapse rate have been reported, as well as a 41% reduction in the proportion of patients who relapsed, and a 54% reduction in the number of new lesions[5]. A 2013 Cochrane systematic review concluded that there was insufficient evidence to determine the efficacy of daclizumab relative to placebo in people with relapsing-remitting MS and, prior to its being discontinued, the need to investigate longer lengths of treatment and follow-up.[6]

Discontinued use

Daclizumab was approved and used to prevent acute rejection of kidney transplant, along with cyclosporine and corticosteroids.[7] For that indication, side effects with a frequency of at least 10% included sleeplessness, tremor, headache, arterial hypertension, dyspnoea, gastrointestinal side effects and oedema. In rare cases, the drug could cause severe anaphylaxis.[8]

Contraindications

In the US, daclizumab is contraindicated in people with liver impairment, including significantly elevated liver enzymes (ALT, AST) and autoimmune hepatitis.[9]

The European Medicines Agency (EMA) originally approved the drug without any contraindications apart from known hypersensitivity,[10] but required Biogen to implement a hepatic risk management guide for physicians.[11] In July 2017, the EMA has issued a provisional contraindication for patients with pre-existing liver disease or liver impairment.[12] The marketing authorisation was withdrawn in the EU on 27 March 2018. An EMA review concluded that the medicine poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.[13]

Adverse effects

In clinical trials for MS, there were no treatment-related deaths or increased risk of cancer; side effects that occurred more frequently with daclizumab versus interferon included infections (65% versus 57%), skin rashes (37% versus 19%) and liver complications (approximately 18% versus 12%).[5]

Interactions

As an antibody, daclizumab is expected to have a very low potential for pharmacokinetic interactions with other drugs.[10]

Pharmacology

Mechanism of action

Daclizumab blocks IL-2 receptors containing the alpha subunit (CD25), which include the high-affinity receptors. Medium-affinity receptors, on the other hand, consist of two beta subunits (CD122) and are not affected by daclizumab. While the exact mechanism is unknown, the net effect is a reduction of T-cell responses and expansion of CD56bright natural killer cells.[10]

Pharmacokinetics

After subcutaneous injection of a single dose, daclizumab has a bioavailability of about 90% and reaches highest blood plasma levels after 5 to 7 days. Given every four weeks, steady state concentrations are found after the fourth dose. It is expected that daclizumab, like other antibodies, is degraded by proteases to peptides and finally amino acids, and that it does not interact with cytochrome P450 liver enzymes.[10]

The biological half-life is 21 days. Patients who developed antibodies against daclizumab eliminated it 19% faster.[10]

History

Daclizumab was created by scientists at PDL BioPharma (called "Protein Design Labs" at that time) by humanizing the mouse mAb called anti-Tac, which targets CD25, the IL-2 receptor α chain; it blocks the interaction of IL-2 with the IL-2 receptor and prevents activation of T cells.[14] Anti-Tac had been discovered by Thomas A. Waldmann, M.D., chief of the Metabolism Branch at the National Cancer Institute and his team, and they had conducted animal studies and a small clinical trial of anti-Tac in people with T-cell leukemia, with promising results, but people quickly developed their own antibodies rejecting the mouse protein; Waldman, and his colleagues then approached Protein Design Labs to humanize the antibody.[15] PDL and the NIH scientists then approached Roche, a leader in transplant medicine development, to get the drug developed and approved, as PDL didn't have the resources to actually bring the product to market.[15] In March 2018 the drug was removed from the market worldwide

In December 1997 daclizumab was approved by the FDA for use in preventing acute rejection of kidney transplants, in combination with ciclosporin and corticosteroids; it was the first humanized antibody approved anywhere in the world.[16][17] At launch, the average wholesale price for the drug was estimated to be $6,800 for five doses and it was estimated that annual sales would be between $100 million and $250 million within five years of the launch and it was thought that the drug's use would be expanded for use in other organ transplants.[17] It was approved in Europe in 1999.[18]

PDL began clinical trials of daclizumab on its own, and in September 2004 after the drug had shown promise in a Phase II trial, PDL and Roche agreed to expand their relationship to include codevelopment of daclizumab for asthma and other respiratory conditions.[19] In August 2005, PDL and Biogen Idec agreed to collaborate to develop daclizumab in indications outside the fields of organ rejection and respiratory disease.[20] In November 2005 Roche and PDL agreed to try to develop a formulation of daclizumab that would be useful as a subcutaneous injection for longterm maintenance in organ transplant.[21] The next year Roche and PDL announced that the collaboration for all indications was ending,[22] and in 2009 it announced that it was discontinuing Zenapax worldwide "in view of available alternative treatments and the diminishing market demand" and "not due to any safety issue."[23][24]

in 2008 PDL spun out its active development programs into a company called Facet Biotech and development of daclizumab for multiple sclerosis and the partnership with Biogen was included in that spinout.[25][26] In 2009 Biogen attempted a hostile buy out of Facet for $350M;[27] Facet rejected that offer and was purchased by Abbvie for $450 million in cash the next year.[28] In May 2016 the FDA approved daclizumab for the treatment of relapsing multiple sclerosis in adults in 2016 under the trade name Zinbryta, with requirements for postmarketing studies and to submit a formal Risk Evaluation and Mitigation Strategy.[4][29]

Research

Daclizumab has been studied in a small clinical trial of people with birdshot chorioretinopathy.[30]

References

  1. ^ a b "FDA working with manufacturers to withdraw Zinbryta from the market in the United States". U.S. Food and Drug Administration (FDA). Retrieved 15 March 2018.
  2. ^ "Biogen, AbbVie withdraw multiple sclerosis drug Zinbryta". Reuters. 2018.
  3. ^ Loftus, Peter (2 March 2018). "Biogen and Abbvie Take Multiple Sclerosis Drug Off Market". The Wall Street Journal.
  4. ^ a b FDA BLA Approval letter May 27, 2016
  5. ^ a b c Lycke J (November 2015). "Monoclonal antibody therapies for the treatment of relapsing-remitting multiple sclerosis: differentiating mechanisms and clinical outcomes". Therapeutic Advances in Neurological Disorders. 8 (6): 274–93. doi:10.1177/1756285615605429. PMC 4643868. PMID 26600872.
  6. ^ Liu, Jia; Wang, Lu-Ning; Zhan, Siyan; Xia, Yinyin (2013-12-23). "Daclizumab for relapsing remitting multiple sclerosis". The Cochrane Database of Systematic Reviews (12): CD008127. doi:10.1002/14651858.CD008127.pub4. ISSN 1469-493X. PMID 24363032.
  7. ^ Rejection label Supplement label update September 2005
  8. ^ "EPAR for Zenapax" (PDF). European Medicines Agency. 2007.
  9. ^ FDA Professional Drug Information for Zinbryta.
  10. ^ a b c d e Haberfeld, H, ed. (2016). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag.
  11. ^ "Zinbryta Summary of Product Characteristics" (PDF). European Medicines Agency. 2016.
  12. ^ "Zinbryta Article-20 referral - Summary of provisional measures" (PDF). European Medicines Agency. 20 July 2017.
  13. ^ "EMA review of Zinbryta confirms medicine's risks outweigh its benefits". European Medicines Agency. 27 March 2018.{{cite web}}: CS1 maint: url-status (link)
  14. ^ Tsurushita N, Hinton PR, Kumar S (May 2005). "Design of humanized antibodies: from anti-Tac to Zenapax". Methods. 36 (1): 69–83. doi:10.1016/j.ymeth.2005.01.007. PMID 15848076.
  15. ^ a b Swenson RS, Weisinger JR, Ruggeri JL, Reaven GM (February 1975). "Evidence that parathyroid hormone is not required for phosphate homeostasis in renal failure". Metabolism. 24 (2): 199–204. doi:10.1016/0026-0495(75)90021-9. PMID 1113683.
  16. ^ Lawrence M. Fisher for The New York Times. December 12, 1997 Genetically Engineered Drug Approved for Kidney Transplants
  17. ^ a b Staff, The Pharma Letter. December 17, 1997. Roche's Zenapax Gets First Approval For Transplants
  18. ^ Roche. March 04, 1999 Roche Press Release: Zenapax (daclizumab), The First Humanized Monoclonal Antibody To Prevent Organ Rejection, Approved In The European Union
  19. ^ Candace Hoffmann for First Word Pharma. September 16, 2004 Roche in new deal to co-development asthma drug
  20. ^ Thiel KA (October 2005). "A very firm handshake: biotech's growing negotiating power". Nature Biotechnology. 23 (10): 1221–6. doi:10.1038/nbt1005-1221. PMID 16211058. S2CID 19365410.
  21. ^ Staff, PharmaTimes. November 1, 2005 Roche inks new deal for transplant drug
  22. ^ PharmaTimes November 23, 2006 Roche ducks out of transplant drug alliance
  23. ^ EMEA: Withdrawal of the marketing authorisation in the European Union
  24. ^ Roche via the FDA Letter to Healthcare Professionals September 2009
  25. ^ John Carroll for FierceBiotech. 2009 Emerging Drug Developer: Facet Biotech
  26. ^ PDL BioPharma, Inc. Form 8-K December 17, 2008
  27. ^ Luke Timmerman for Xconomy. September 4, 2009 Biogen Idec Makes Hostile $350M Takeover Bid for Facet Biotech
  28. ^ Staff, New York Times Dealbook. March 9, 2010. Abbott to Buy Facet Biotech for 67% Premium
  29. ^ FDA News Release: FDA approves Zinbryta to treat multiple sclerosis May 27, 2016
  30. ^ Sobrin L, Huang JJ, Christen W, Kafkala C, Choopong P, Foster CS (February 2008). "Daclizumab for treatment of birdshot chorioretinopathy". Archives of Ophthalmology. 126 (2): 186–91. doi:10.1001/archophthalmol.2007.49. PMID 18268208.
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