Date: 2015-11-18
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Academy of Ophthalmology (AAO) 2015 meeting,
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: symptomatic vitreomacular adhesion or vitreomacular traction (VMT) 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 November 18, 2015, ThromboGenics provided an overview of the presentations on Jetrea®, which focused on the analysis of the OASIS study data, from the American Academy of Ophthalmology (AAO) 2015 meeting, held in Las Vegas from 14-17 November.
Peter K. Kaiser, MD, Department of Ophthalmology, Cole Eye Institute, Cleveland Clinic, Cleveland, OH, gave a presentation on- "The OASIS Study: Evaluating Ocriplasmin for the Treatment of Symptomatic VMA/VMT Including Macular Hole Over 2 Years." The 24-month follow-up data is the longest period patients with symptomatic VMA (sVMA)/VMT have been studied post-treatment with Jetrea®.
In his presentation Dr Kaiser confirmed the previously announced top-line results from the OASIS study, showing that 41.7% of patients with sVMA treated with Jetrea® achieved resolution at Day 28 post-injection compared with only 6.2% of patients who received a sham injection (p<0.001).
Dr Kaiser also provided further analyses showing the importance of patient selection in achieving VMA resolution in patients with symptomatic VMA/VMT.
Dr Kaiser's presentation also provided further analyses of the safety data relating to Jetrea®. These analyses showed that no new safety signals were identified. The adverse events which were observed were consistent with those observed in previous studies, and resolved in the majority of cases within specified time periods.
A second presentation was given by Pravin U. Dugel, MD, Retina Consultants of Arizona, Phoenix, AZ and USC Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, on "OASIS: A 2-Year Study Evaluating Ocriplasmin for the Treatment of Symptomatic VMA/(VMT) Including Macular Hole."
In his presentation Dr Dugel provided additional analyses showing that the VMA resolution at Day 28 in patients treated with Jetrea® was maintained for the full 24-month follow-up period. Jetrea® treatment did not impact the visual acuity (BCVA) of patients who subsequently had to undergo a vitrectomy. Improved patient selection may result in increased resolution rates with a consistent safety profile. Dr Dugel also confirmed the safety findings that were presented by Dr Kaiser.
A third presentation was made by Robert C. Sergott, MD, Thomas Jefferson University & Wills Eye Hospital, Philadelphia, PA. The presentation was entitled, "OASIS: Sub-study Evaluation of Full-Field Electroretinogram (ffERG) in Subjects Treated with Ocriplasmin vs Sham." In his presentation Dr Sergott, presented the results of the ERG sub-study with 61 patients followed up over a period of 2 years.
Is
general: Yes
