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`Home / Min= I Eylea Pre-Filled Syringe PBS Li.sted, Indications Expanded
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`M.l.l:,l,.EW.S,/ QCTOAFB 16 2020 / AUTHOR: M.UlLS.LQI:,L
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`Eylea Pre-filled Syringe PBS Listed,
`Indications Expanded
`
`Australian clinicians can now use a new pre-filled syringe to ad.minister Eylea for four
`retinal conditions at a subsidised rate via the Pharmaceutical Benefits Scheme (PBS). 1
`
`The new pre-filled syringe provides clinicians with a further option for treatment, requiring fewer steps to
`prepare for intravitreal injection than vial presentations.
`
`"EYLEA is a proven treatment option for reducing preventable vision loss in eligible patients,
`demonstrated in both clinical studies and real-world clinical settings," said Dr Eduardo Pimenta, Country
`Medical Director at Bayer Pharmaceuticals Australia and New Zealand. •we're extremely pleased to further
`enhance our treatment offering through the introduction of the pre-filled syringe."
`
`'' The new pre-filled syringe provides clinicians with a further
`
`option for treatment, requiring fewer steps to prepare for
`intravitreal injection than vial presentations
`
`From I October 2020, PBS listing for Eylea includes administration via vial or pre-filled syringe for all
`listed indications, including the treatment of a newly listed indication, for use in patients with subfoveal
`choroidal neovascularisation due to pathologic myopia. 1
`
`Pathologic myopia (PM) is a severe form of myopia, or short-sightedness, associated with an abnormal
`elongation of the eyeball and high myopia. Choroidal neovascularisation (CNV) is a vision-threatening
`complication of PM and is characterised by the growth of pathologic new blood vessels from the
`choriocapillaris through a break in the Bruch's membrane into the space under the retinal pigment
`epithelium or retina. 2
`
`Results of the Phase 3 MYRROR study ofEylea in myopic CNV (mCNV) demonstrate that a limited
`number of injections with Eylea given in the first eight weeks of treatment achieved clinically meaningful
`visual improvements and anatomic benefits that were maintained and extended through week 48.3
`
`The PBS listing ofEylea for subfoceal mCNV is expected to benefit around 700 Australian patients each
`year.4
`
`"Bayer is committed to making Eylea accessible for all patients who may benefit. We set out to provide
`patients suffering from mCNV with greater access to an effective, sight-saving treatment, and were thrilled
`to have secured increased access via the PBS," said Dr Eduardo Pimenta.
`
`References
`
`I. Australian Government Department of Health. Pharmaceutical Benefits Schedule. Available at:
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`m IYFss10 r,,i,FEATURE V
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`1/3
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`Novartis Exhibit 2278.001
`Regeneron v. Novartis, IPR2021-00816
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`2020.
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`2. Neelam, K. et al Choroidal neovascularization in pathological myopia. Progress in Retinal and
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`Eye Research. 2012;31(5):495-525. doi: 10.1016/j.preteyeres.2012.04.001
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`3. lkuno, K. et al lntravitreal Aflibercept Injection in Patients with Myopic Choroidal
`
`Neovascularization: The MYRRORSrudy. Ophthalmology. 2015;122(6):1220-7. doi:
`
`10.1016/j.ophtha.2015.01.025
`
`4. Bayer. Data on file.
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`2/3
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`Novartis Exhibit 2278.002
`Regeneron v. Novartis, IPR2021-00816
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`

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`DFCEMBEB 2 202]
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`3/3
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`Novartis Exhibit 2278.003
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