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`Home / Mi!!= / Eylea Pre-Filled Syringe PBS Listed, Indications Expanded
`
`Ml NEWS/ DECEMBER 1 2020 / AUTHOR : MIVISION
`
`Eylea Pre-filled Syringe PBS Listed,
`Indications Expanded
`
`Retinal specialists in Australia have welcomed the listing of a new pre-filled syringe to
`
`administer Eylea, manufactured by Bayer, on the Pharmaceutical Benefits Scheme (PBS) for
`
`treatment of four retinal conditions at a subsidised rate.1
`
`The new pre-filled syringe provides clinicians with a further option to treat age related macular
`degeneration (AMD), diabeticmacular oedema, retinal vein occlusion and subfoveal choroidal
`neovascularisation (CNV).
`
`Professor Paul Mitchell, Director of the Centre for Vision Research at The Westmead lnstitute for Medical
`Research in Sydney, described the pre-filled syringe as "a major innovation" that would improve
`efficiency and safety for both practitioners and patients.
`
`'' As well as reducing the risk of drug contamination and blinding
`
`endophthalmitis ... the pre-filled syringe streamlines the
`intravitreal injection process
`
`"This means all of the anti-VEGFs we now use are in pre-filled syringes. It saves time and is likely to reduce
`the likelihood of endophthalmitis, as was suggested in the French National Study. 2 Bayer are to be
`applauded for its introduction. The particular device is pleasant to use and looks to be accurate in delivering
`the correct dose," said Prof Mitchell.
`
`Dr Simon Chen, Vision Eye Institute, said the availability ofEylea in a new sterilised prefilled syringe was
`positive news for retinal specialists in Australia.
`
`"Prior to this, we had to transfer Eylea from a glass vial into a plastic syringe using a needle before injecting
`it into a patient's eye."
`
`m Iv Is I o niews V
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`MIFEATURE v
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`MIEDUCATION v
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`MIEYECARE v
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`MIEYEWEAR v
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`MIEVENTS V
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`MICLASSIFIEDS v
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`1/3
`
`Novartis Exhibit 2036.001
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`"The use of a prefilled syringe can improve clinical efficiency as the doctor needs to perform fewer steps,
`which saves time for both the patient and the doctor. There are a1so benefits for the environment as
`fewer needles, less plastic and less wasted packaging are used for each injection."
`
`From 1 October 2020, PBS listing for Eylea administration via vial or pre-filled syringe also applies to the
`treatment of patients with CNV due to pathologic myopia (PM). 1
`
`PM is a severe form of myopia associated with an abnormal elongation of the eyeball and high myopia.
`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. 3
`
`Dr Chen said this new listing for treatment ofCNV due to PM is expected by Bayer to benefit around 700
`Australian patients each year.
`
`"Myopic CNV (mCNV) is one of the most serious complications of pathologic myopia, often causing a
`progressive decline in central vision with a poor prognosis unless treated. Approximately 35% of patients
`with myopic CNV develop bilateral disease.
`
`"Unlike CNV associated with AMD, myopic CNV is more often a disease of middle rather than older age.
`The average age that treatment typically begins for a myopic CNV patient is around 58 years. Unlike anti(cid:173)
`VEGF therapy for patients with neovascular (wet) AMD who often need long-term regular injections over
`the course of many years, patients with myopic CNV typically need a much more limited number of
`injections, often only one to three injections given over the course of one to six months."
`
`Indeed, results of the Phase 3 MYRROR study of Eylea in 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. 4
`
`References
`
`1. Australian Government Department of Health. Pharmaceutical Benefits Schedule. Available at:
`www.pbs.gov.au/pbs/home;jsessionid~iuycz8ls6usw1/3aszoquvpxz. Accessed October 2020.
`2. Baudin F, Benzenine E, Mariet A, Bron AM, Daien V, Korobelnik]F,, Quantin C, Creuzot-Garcher C.
`Association of Acute Endophthalmitis with lntravitreal Injections of Corticosteroids or Anti-Vascular
`Growth Factor Agents in a Nationwide Study in France.JAMA Ophthalmology. DOI:
`10.1001/jamaophtha/mo/.2018.3939
`3. Nee/am, K. et al. Choroidal neovascularization in pathological myopia. Progress in Retinal and Eye
`Research. 2012;31 (5):495-525. doi: 10. JO 16/j.preteyeres.2012.04.001
`4. Ikuno, K. et al. lntravitreal Aflibercept Injection in Patients with Myopic Choroidal Neovascularization:
`The MYRROR Study. Ophthalmology. 2015;122(6):1220-7. doi:10./016/j.ophtha.2015.01.025
`
`New ARP- Connects HCPs With
`Life Sciences
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`➔
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`Ml NEWS
`\YTr. rU <;:i a ht n ,,u ? fl1 1 Ph n t n r nlT'lnPMMnn ()n..,n c
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`m Iv Is I o niews V
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`MIFEATURE v
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`MIEDUCATION V
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`MIEYECARE v
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`MIEYEWEAR v
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`MIEVENTS V
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`MICLASSIFIEDS V
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`2/3
`
`Novartis Exhibit 2036.002
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`About Us
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`Contact
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`mivision is the key communication portal for ophthalmic professionals, who live and
`work in Australia and New Zealand. more ...
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`1627 Botany Rd, Banksmeadow, NSW, 2019, Australia
`Phone: +61 2 8336 8616
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`© TOMA PUBLISHING PTY LTD
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`3/3
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`Novartis Exhibit 2036.003
`Regeneron v. Novartis, IPR2021-00816
`
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