28-Sep-2020
Inceptua receives approval of marketing authorization transfer of Jetrea® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion
LUXEMBOURG – 28 September, 2020 – Life Science Newswire – Inceptua Group – pharmaceutical company and service partner announces that the European Commission (EC) has approved the transfer of the marketing authorisation for Jetrea® (ocriplasmin), a first-in-class pharmacological vitreolysis therapy approved for treatment of symptomatic vitreomacular adhesion (VMA) or vitreomacular traction (VMT) from Oxurion NV to Inceptua AB.
As marketing authorisation holder, Inceptua will assume full regulatory responsibility for Jetrea in the EU, Norway, Iceland, and Liechtenstein.
"We are pleased that the European Commission has granted approval for Inceptua to market Jetrea," says Clive Whitcher, Executive Vice President and Head of Inceptua Pharma.
"For Inceptua Group Jetrea represents a unique opportunity to build on our commitment to specialty care and enhances our ability to ultimately help patients suffering from symptomatic vitreomacular adhesion or vitreomacular traction and support physicians specializing in eye diseases."
Jetrea was launched in early 2013, and over 35,000(1) patients have been treated with the product to-date with real world clinical data(2-4) confirming efficacy and safety in a well identified group of patients suffering from symptomatic vitreomacular adhesion or vitreomacular traction.
VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like material in the back of the eye) to the macula. The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as distorted and blurring of visual acuity or decreased vision. When the disease progresses, the traction may result in damage on the retina and risk of permanent visual impairment.
Inceptua Pharma — a part of Inceptua Group with offices across Europe, North America, and Asia — is an expert commercialization partner for Europe for rare disease and specialty care products with the expertise and capabilities to also supply unlicensed medicines globally.
About Inceptua Group — Pharma Company & Service Partner
Inceptua is a specialty pharmaceutical company and a premium global service partner.
Inceptua Pharma commercializes and market orphan and specialty care products and have also the expertise and capabilities to supply unlicensed medicines globally.
Inceptua Services supports pharma and biotech companies with global clinical trial comparator sourcing, packaging and labelling solutions, pre-approval and medicines access programs and consulting.
Inceptua partners with life science companies of all sizes, drawing on over 20 years of industry experience, and has global operations with local offices across Europe, North America, and Asia.
www.inceptua.com
For further information, please contact:
Morten Grøn
morten.gron@inceptua.com
Mobile: +45 2556 4781
Jetrea is a trademark of Oxurion NV
1. PSUR data on file and patients treated in trials and studies
2. Khanani et al., Ophthalmol. 2019; 3 (1): 32-41
3. Tadayoni et al., Retina. 2019; 39( 12): 2341–2352
4. Steel et al., Retina. 2020. 00: 1–11
As marketing authorisation holder, Inceptua will assume full regulatory responsibility for Jetrea in the EU, Norway, Iceland, and Liechtenstein.
"We are pleased that the European Commission has granted approval for Inceptua to market Jetrea," says Clive Whitcher, Executive Vice President and Head of Inceptua Pharma.
"For Inceptua Group Jetrea represents a unique opportunity to build on our commitment to specialty care and enhances our ability to ultimately help patients suffering from symptomatic vitreomacular adhesion or vitreomacular traction and support physicians specializing in eye diseases."
Jetrea was launched in early 2013, and over 35,000(1) patients have been treated with the product to-date with real world clinical data(2-4) confirming efficacy and safety in a well identified group of patients suffering from symptomatic vitreomacular adhesion or vitreomacular traction.
VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like material in the back of the eye) to the macula. The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as distorted and blurring of visual acuity or decreased vision. When the disease progresses, the traction may result in damage on the retina and risk of permanent visual impairment.
Inceptua Pharma — a part of Inceptua Group with offices across Europe, North America, and Asia — is an expert commercialization partner for Europe for rare disease and specialty care products with the expertise and capabilities to also supply unlicensed medicines globally.
About Inceptua Group — Pharma Company & Service Partner
Inceptua is a specialty pharmaceutical company and a premium global service partner.
Inceptua Pharma commercializes and market orphan and specialty care products and have also the expertise and capabilities to supply unlicensed medicines globally.
Inceptua Services supports pharma and biotech companies with global clinical trial comparator sourcing, packaging and labelling solutions, pre-approval and medicines access programs and consulting.
Inceptua partners with life science companies of all sizes, drawing on over 20 years of industry experience, and has global operations with local offices across Europe, North America, and Asia.
www.inceptua.com
For further information, please contact:
Morten Grøn
morten.gron@inceptua.com
Mobile: +45 2556 4781
Jetrea is a trademark of Oxurion NV
1. PSUR data on file and patients treated in trials and studies
2. Khanani et al., Ophthalmol. 2019; 3 (1): 32-41
3. Tadayoni et al., Retina. 2019; 39( 12): 2341–2352
4. Steel et al., Retina. 2020. 00: 1–11
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Last Updated: 28-Sep-2020
