Importance of proper patient selection demonstrated
No new safety signals identified, majority of adverse events resolve
LEUVEN, Belgium, Nov. 18, 2015 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today provides 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.
Speaking at a ThromboGenics-organized AAO media breakfast meeting, Dr. Arshad Khanani, Managing Partner of Sierra Eye Associates in Reno, Nevada confirmed the above when commenting about his experience with JETREA® for the treatment of symptomatic vitreomacular adhesion: "JETREA® is an important part of my toolbox when treating patients with symptomatic VMA. By using careful patient selection, a very high rate of VMA resolution can be achieved. Of the 27 patients I have treated in the ORBIT study, 21 have achieved VMA resolution with a single injection of JETREA®."
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.
Robert C. Sergott, MD, Thomas Jefferson University & Wills Eye Hospital, Philadelphia, PA, comments: "From the 16 of 40 subjects in the ocriplasmin group with ERG changes, we have concluded that ERG changes following ocriplasmin clearly trended towards greater proportion of VMA release compared with no ERG changes. Moreover, 15 of 16 of the patients gained or maintained visual acuity by study end, which indicated that the development of ERG changes was associated with long-term improvement in visual acuity. Finally, this ERG sub-study of the OASIS study, one of the largest ever of its kind, was prospective, randomized, double-masked and has clearly indicated that ERG changes and visual function in enzymatic vitreolysis must be analysed over a period of months, not days or weeks", he concludes.
Dr Patrik De Haes, the CEO of ThromboGenics, commenting on today's announcement, "The further data analyses from the OASIS study that were presented at the AAO meeting continue to confirm that a single injection of JETREA® is a compelling treatment option for an important group of patients with symptomatic VMA. The new data presented emphasize the importance of patient selection in achieving optimal outcomes with JETREA®, particularly ensuring the absence of ERM.
OASIS also confirms the safety profile of JETREA® with no new safety findings identified. The much-discussed ERG changes that have been observed in certain patients following ocriplasmin may be due to the drug's mechanism of action in releasing traction. Importantly, the majority of these changes do resolve in almost all patients, and seem to be associated with improved visual acuity for the patient.
Given the reported OASIS data and the ever-growing body of real-world reports demonstrating its attractive clinical profile, I remain confident that JETREA® will further develop its position as an important treatment option in a changing standard of care for patients with symptomatic VMA."
For further information please contact:
| ThromboGenics |
Wouter Piepers, Global Head of Corporate Communications & IR
+32 16 75 13 10 / +32 478 33 56 32
| Citigate Dewe Rogerson |
David Dible/Sylvie Berrebi
Tel: +44 20 7282 2867
About JETREA ® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. JETREA® acts as a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
In the US, JETREA® is indicated for the treatment of symptomatic vitreomacular adhesion. In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. To-date over 20,000 patients with symptomatic VMA/VMT have been treated globally with JETREA®.
JETREA® was evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28. This Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA® was generally well tolerated with most adverse events being transient and mild in severity.
In March 2015, ThromboGenics reported top line results from OASIS, a Phase IIIb study. This randomized, sham controlled, double masked study followed-up patients for 24 months post-injection. In this study, retina physicians were able to use SD-OCT to better select patients with focal VMA and without Epiretinal Membrane (ERM), two criteria which have been shown to lead to better treatment outcomes with JETREA®.
The trial showed that 41.7% of patients treated with JETREA® achieved VMA resolution at Day 28 post injection compared with only 6.2% of patients who received a sham injection (p<0.001). Further analyses presented at AAO showed that 50.6% of the patients treated with JETREA® without an epiretinal membrane (ERM) present at baseline achieved VMA resolution at Day 28 and that 45.4% of patients with focal VMA at baseline achieved VMA resolution at Day 28 following treatment with JETREA®.
The OASIS study showed that the drug's safety profile in the 24 month follow-up period was consistent with the drug's overall safety profile as known from the approved label.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative treatments for diabetic eye disease.
The Company's first product, JETREA® (ocriplasmin), has been approved in 53 countries across the globe. In the US, ThromboGenics is commercializing JETREA® via its subsidiary ThromboGenics, Inc. ThromboGenics signed an agreement with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States.
ThromboGenics is planning the CIRCLE study, a Phase II clinical trial with JETREA® in diabetic retinopathy and expects to recruit the first patient into the study around the end of 2015. In addition to JETREA®, the Company is evaluating several other drug candidates that could potentially deliver a number of next generation treatments for diabetic eye disease.
ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com .
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.