A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes

Lode, Heidrun Elisabeth; Gjølberg, Torleif Tollefsrud; Foss, Stian; Sivertsen, Magne Sand; Brustugun, Jørgen; Andersson, Yvonne; Jørstad, Øystein Kalsnes; Moe, Morten C.; Andersen, Jan Terje

doi:10.1038/s41598-019-54226-7

Cited by 28 publications

(27 citation statements)

References 34 publications

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“…This contributes to SO release and this maneuver is unnecessary due to the amount of drug in the original vial [ 55 , 56 ]. SO-free syringes have been studied and shown to not compromise the functional activity of ophthalmic intravitreal anti-VEGF biologics in the compounding process, and may be a safe and cost-effective alternative to siliconized syringes [ 84 ]. It is important to note that SO droplets are still possible even with SO-free syringes when a siliconized needle is attached to the syringe.…”

Section: Discussionmentioning

confidence: 99%

Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review

et al. 2021

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Background Intraocular inflammation is an uncommon but potentially vision-threatening adverse event related to anti-VEGF therapy. This is of increasing importance given both the volume of injections performed, as well as the increased prevalence of inflammation seen with newer anti-VEGF agents. Brolucizumab, the newest anti-VEGF agent, has been associated with an inflammatory retinal vasculitis and the underlying mechanism is unclear. Reviewing potential mechanisms and clinical differences of intraocular inflammation may assist clinicians and scientists in reducing the risk of these events in the future. Observations Two types of inflammation are seen with intravitreal injections, acute onset sterile inflammation and delayed onset inflammatory vasculitis. Acute onset inflammation can be subcategorized into subclinical anterior chamber inflammation and sterile uveitis/endophthalmitis. Subclinical anterior chamber inflammation can occur at rates as high as 19% after intravitreal anti-VEGF injection. Rates of sterile uveitis/endophthalmitis range from 0.05% to 4.4% depending on the anti-VEGF agent. Inflammatory vasculitis is only associated with brolucizumab and occurred in 3.3% of injections according to the post hoc review of the HAWK/HARRIER data. In addition, silicone oil from syringes can induce immunogenic protein aggregates. Agitation of the syringe, freeze thawing, shipping and improper storage prior to injection may increase the amount of silicone oil released from the syringe. Conclusion The main factors which play a role in intraocular inflammation after anti-VEGF injection can be divided into three causes: patient-specific, medication-specific and delivery-specific. The majority of clinically significant inflammation seen after intravitreal injection is an acute onset inflammatory response with most patients recovering baseline VA in 3–5 weeks. The presence of pain, hypopyon, severe anterior chamber reaction, hyperemia and significant vision loss may help distinguish infectious from non-infectious etiologies of post injection inflammation. Avoiding temperature fluctuation, mechanical shock, agitation during transport and handling of syringes/drugs, and the use of SO-free syringes may help minimize intraocular inflammation. While a definitive mechanism has not yet been established, current knowledge of the clinical presentation and vitreous histopathology of brolucizumab-retinal vasculitis favors an auto-immune type IV hypersensitivity reaction.

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Section: Discussionmentioning

confidence: 99%

Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review

et al. 2021

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“…Lode et al recently published a method for refilling anti-VEGF drugs into silicone oil-free plastic syringes in Norway. 56 In the test performed, a stability of the anti-VEGF drugs over 1 week could be proven. Further studies are necessary to make this desirable filling method available to other countries.…”

Section: Options To Reduce Contamination and Side Effectsmentioning

confidence: 99%

<p>Issues with Intravitreal Administration of Anti-VEGF Drugs</p>

Schargus¹,

Фрингс²

2020

OPTH

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Purpose: To provide an update of summary of risk factors and side effects of long-term use and contamination of intravitreal anti-VEGF injections. Methods: We reviewed relevant publications of the topic of contamination of anti-VEGF injections and long-term side effects due to this reason. Results: Due to the long-term use of anti-VEGF drugs and the higher number of injections worldwide, various studies have shown side effects in recent years, ranging from increased intraocular pressure to visual disturbing silicone oil vesicles in the vitreous cavity. Several studies have demonstrated that both the drug and the processing, storage, environmental factors and the material and design of the syringes have a decisive influence on these side effects.Conclusion: The risks of deposits from syringes in the eye can be significantly reduced by various optimizations in transport, storage and syringe and cannula selection.

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“…Dette er bakgrunnen for en tjenesteinnovasjon ved Oslo universitetssykehus, Universitetet i Oslo og Sykehusapoteket Oslo. Det tverrfaglige prosjektet har utviklet og kvalitetssikret en prosedyre for magistrell produksjon som gjør det mulig å dele innholdet i anti-VEGF-ampullene på flere sprøyter med svaert lavt dødvolum (2,3). Resultatet er at hver ampulle gir to til tre doser, og at samfunnet spares for store legemiddelutgifter.…”

Section: Morten Carstens Moeunclassified

Kan ampullene med covid-19-vaksine utnyttes bedre?

Jørstad¹,

Sivertsen²,

Andersen³

et al. 2020

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Øystein Kalsnes Jørstad er ph.d., spesialist i øyesykdommer og overlege ved Øyeavdelingen ved Oslo universitetssykehus. Forfatteren har fylt ut ICMJE-skjemaet og oppgir via teknologioverføringskontoret Inven2 å ha et pågående samarbeid med det nederlandske firmaet SJJ Solutions om utvikling av en spesialdesignet sprøyte for øyeinjeksjoner. Det foreligger avtale om royalties. MAGNE SAND SIVERTSEN Magne Sand Sivertsen er ph.d., spesialist i øyesykdommer og overlege ved Øyeavdelingen ved Oslo universitetssykehus. Forfatteren har fylt ut ICMJE-skjemaet og oppgir via teknologioverføringskontoret Inven2 å ha et pågående samarbeid med det nederlandske firmaet SJJ Solutions om utvikling av en spesialdesignet sprøyte for øyeinjeksjoner. Det foreligger avtale om royalties. JAN TERJE ANDERSEN Jan Terje Andersen er ph.d., forskningsgruppeleder ved Oslo universitetssykehus og professor ved Institutt for klinisk medisin ved Universitetet i Oslo. Forfatteren har fylt ut ICMJE-skjemaet og oppgir via teknologioverføringskontoret Inven2 å ha et pågående samarbeid med det nederlandske firmaet SJJ Solutions om utvikling av en spesialdesignet sprøyte for øyeinjeksjoner. Det foreligger avtale om royalties.

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A new method for pharmaceutical compounding and storage of anti-VEGF biologics for intravitreal use in silicone oil-free prefilled plastic syringes

Cited by 28 publications

References 34 publications

Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review

Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review

<p>Issues with Intravitreal Administration of Anti-VEGF Drugs</p>

Kan ampullene med covid-19-vaksine utnyttes bedre?

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