Ocriplasmin

From WikiProjectMed
Jump to navigation Jump to search
Ocriplasmin
Names
Trade namesJetrea
Clinical data
Drug classProtease[1]
Main usesVitreomacular traction[2]
Side effectsFloaters, eye pain, flashes of light, conjunctival bleeding[2]
Pregnancy
category
  • AU: B2
  • US: C (Risk not ruled out)
Routes of
use
Intravitreal
External links
AHFS/Drugs.comMonograph
US NLMOcriplasmin
Legal
License data
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
Chemical and physical data
FormulaC1214H1890N338O348S14
Molar mass27237.33 g·mol−1

Ocriplasmin, sold under the brand name Jetrea, is a medication used for vitreomacular traction.[2] It is used for milder disease and may prevent the need for surgery.[1] It is given by injection into the eye.[2]

Common side effects include floaters, eye pain, flashes of light, and conjunctival bleeding.[2] Other side effects may include intraocular bleeding, increased intraocular pressure, and intraocular infection.[1] It is similar to natural plasmin and works by breaking down proteins between the vitreous and the retina.[2]

Ocriplasmin was approved for medical use in the United States in 2012 and Europe in 2013.[3][2] In the United Kingdom it costs the NHS £2,500 per 0.375 mg vial as of 2021.[4] This amount in the United States costs about 3,100 USD.[5]

Medical uses

Dosage

It is given as a 125 ucg dose.[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.

It is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. It works by dissolving the proteins that link the vitreous to the macula, resulting in posterior detachment of the vitreous from the retina.[6]

Chemistry

Ocriplasmin is an injectable drug that is "a truncated form of the human serine protease plasmin." The protease plasmin still retains its enzymatic properties.[7] 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.[8]

Society and culture

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.[9] 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.[10] This may be controversial, considering the drug underwent only two studies.[11]

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.[12][13]

60% of the market of ocriplasmin is in the United States, with more than a quarter of a million patients.[12]

References

  1. 1.0 1.1 1.2 "Ocriplasmin Monograph for Professionals". Drugs.com. Retrieved 7 November 2021.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 "Jetrea". Retrieved 6 November 2021.
  3. "Jetrea" (PDF). Retrieved 6 November 2021.
  4. 4.0 4.1 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 1237. ISBN 978-0857114105.
  5. "Jetrea Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 6 November 2021.
  6. 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.
  7. "FDA panel backs ocriplasmin." (2012) European Biotechnology News.
  8. 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.
  9. Carroll J (2012). "ThromboGenics jolted with safety questions on eve of FDA panel review". FierceBiotech.
  10. McBride R (2012). "ThromboGenics wins FDA panel nod for eye drug". FierceBiotech.
  11. Brown T (2012). "FDA approvals: ocriplasmin for vitreomacular adhesions". MedScape.
  12. 12.0 12.1 Moran N (2013). "ThromboGenics Signs Potential $494M Ex-U.S. Ocriplasmin Deal". BioWorld.
  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.

External links

Identifiers: