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Ocriplasmin - Wikipedia

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Ocriplasmin
Clinical data
Trade names	Jetrea
AHFS/Drugs.com	Monograph
License data	EU EMA: by INN
Pregnancy category	AU: B2
Routes of administration	Intravitreal
ATC code	S01XA22 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)^[1] US: ℞-only EU: Rx-only
Identifiers
CAS Number	1048016-09-6
IUPHAR/BPS	7446
DrugBank	DB08888
ChemSpider	none
UNII	7V6HE3DM5A
KEGG	D09646
Chemical and physical data
Formula	C₁₂₁₄H₁₈₉₀N₃₃₈O₃₄₈S₁₄
Molar mass	27237.33 g·mol⁻¹

Ocriplasmin, sold under the brand name Jetrea, is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. It is used for treatment of symptomatic vitreomacular adhesion, for which it received FDA approval on 17 October 2012. It works by dissolving the proteins that link the vitreous to the macula, resulting in posterior detachment of the vitreous from the retina.^[2]

Structure

Ocriplasmin is an injectable drug that is "a truncated form of the human serine protease plasmin." The protease plasmin still retains its enzymatic properties.^[3] Ocriplasmin consists of two polypeptide chains that are linked by disulfide bonds. Additionally, the longer peptide chain has four disulfide bonds. Ocriplasmin is only moderately stable when injected, and this is due to autolytic degradation.^[4]

Mechanism of action

Ocriplasmin can degrade various structural proteins, including laminin and fibronectin, which are localized in the vitreoretinal surface. Here, these two proteins are involved in vitreoretinal attachment. Ocriplasmin is currently being studied in clinical trials and data indicate that it is able to induce posterior vitreous detachment in vitreomacular adhesion patients.^[4]

FDA regulation

ThromboGenics, the manufacturer of ocriplasmin, encountered several problems when trying to get approval for the drug. In 2012, the FDA brought up the problem of adverse side effects associated with the drug. The FDA stated that the adverse effects may not cause long-term harm, but that conclusion could not be definitively made.^[5] Several days later, the FDA endorsed ocriplasmin, which was still an experimental drug. The advisory committee brought up several safety issues, but the committee ended up voting that no additional studies were needed.^[6] This may be controversial, considering the drug underwent only two studies.^[7]

Sales

As part of a deal with Alcon, ThromboGenics received $98.4 million for the ex-US rights to ocriplasmin. This is part of a $500 million-plus deal. ThromboGenics received a $123 million-plus payment, when ocriplasmin gained approved in the Europe Union; this occurred in March 2013.^[8]^[9]

60% of the market of ocriplasmin is in the United States, with more than a quarter of a million patients.^[8]

References

^ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
^ Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA (August 2012). "Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes". The New England Journal of Medicine. 367 (7): 606–15. doi:10.1056/NEJMoa1110823. hdl:2445/178467. PMID 22894573. S2CID 8213827.
^ "FDA panel backs ocriplasmin." Archived 2016-03-04 at the Wayback Machine (2012) European Biotechnology News.
^ ^a ^b Aerts F, Noppen B, Fonteyn L, Derua R, Waelkens E, de Smet MD, Vanhove M (May 2012). "Mechanism of inactivation of ocriplasmin in porcine vitreous". Biophysical Chemistry. 165–166: 30–8. doi:10.1016/j.bpc.2012.03.002. PMID 22445213.
^ Carroll J (2012). "ThromboGenics jolted with safety questions on eve of FDA panel review". FierceBiotech. Archived from the original on 2016-03-04. Retrieved 2013-12-09.
^ McBride R (2012). "ThromboGenics wins FDA panel nod for eye drug". FierceBiotech. Archived from the original on 2016-03-03. Retrieved 2013-12-09.
^ Brown T (2012). "FDA approvals: ocriplasmin for vitreomacular adhesions". MedScape. Archived from the original on 2016-07-27. Retrieved 2013-12-09.
^ ^a ^b Moran N (2013). "ThromboGenics Signs Potential $494M Ex-U.S. Ocriplasmin Deal". BioWorld. Archived from the original on 2017-10-05. Retrieved 2013-12-13.
^ "ThromboGenics' JETREA granted EU approval for vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns" (PDF). 15 March 2013. Archived from the original (PDF) on 1 September 2013. Retrieved 17 August 2016.

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