Date: 2016-08-08
Type of
information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in Ophthalmology
Company: Thrombogenics (Belgium)
Product: Jetrea® (ocriplasmin)
Action
mechanism:
- protein. Ocriplasmin is a truncated form of the human serine protease plasmin that retains its enzymatic properties. This small molecule has been designed specifically for use in the eye. It is believed to primarily target the fibronectin, laminin, and type IV collagen fibers that adhere the vitreous to the retina.By dissolving these proteins, ocriplasmin releases the traction, and helps to complete the detachment of the vitreous from the macula.It works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present which may decrease the symptoms caused by VMT. Ocriplasmin is administered through a one-time, single intravitreal injection.
Disease: vitreomacular adhesion including macular hole
Therapeutic
area: Ophtalmological diseases
Country: USA
Trial
details:
- The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin. (NCT01429441)
Latest
news:
- • On August 8, 2016, ThromboGenics announced that the results from its 2 Year OASIS Phase IIIb study with JETREA® (ocriplasmin) have been published in the American Academy of Ophtalmology journal Ophtalmology (Results of the 2-Year Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) Randomized Trial). Ophthalmology reviewed the OASIS study which was a Phase IIIb randomized, sham controlled, double masked study that followed up patients for 24 months post injection. The study was designed to provide long term controlled efficacy and safety data for Jetrea® in patients being treated for symptomatic vitreomacular adhesion (sVMA). The study included 24 months follow up data, the longest period patients have been studied post treatment with this novel medicine.
In its overall conclusion, Ophthalmology confirms ‘the OASIS trial demonstrates the long-term efficacy and safety of ocriplasmin, providing improved resolution of symptomatic VMA compared with previous phase 3 trials with no additional safety signals identified’.
The OASIS study results, including the sub-study read out, will be the subject of various presentations delivered at upcoming US and global retina specialists educational meetings, such as next week’s 34th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) in San Francisco, and the Annual Meeting of the American Academy of Ophthalmology (AAO) from the 15th to 18th October in Chicago.
Is
general: Yes
