Data Presented during the EURETINA Congress Highlights Safety Profile and Efficacy of Treatment with JETREA® in Clinical Practice
Sep 13, 2014
Importance of appropriate patient selection for treatment success highlighted
Further evidence of a post-authorization safety profile that is consistent with that observed during the trials
LONDON, September 13, 2014 – Alcon, the global leader in eye care and second-largest division of Novartis, presented four abstracts during sessions at the 14th annual EURETINA congress in London, discussing real-world use of JETREA® (ocriplasmin) in clinical practice, as well as further analyses of the Phase III clinical study program. JETREA® is a one-time, non-surgical treatment for people suffering from vitreomacular traction (VMT), a progressive condition that can lead to disabling visual disturbances and loss of central vision and blindness if left untreated.
Among the real-world data highlighted were two discussions focused on the importance of appropriate patient selection with treatment of JETREA®, as well as evidence of a post-authorization safety profile being consistent with that observed during the Phase III clinical trials. Specifically:
Data from the first study, conducted at the Cleveland Clinic’s Cole Eye Institute, showed that three months following injection with JETREA®, 44% of patients (eight of 18) achieved resolution of vitreomacular adhesion (VMA) and 63% (five of eight) achieved macular hole closure.1
Data from the second single-center study, conducted at the Knappschafts-Augenklinik in Sulzbach, Germany, showed that treatment with JETREA® resolved vitreomacular traction (VMT) one month after injection in 41.6% of eyes treated (10 of 24). In these eyes, a slight improvement in visual acuity was observed one month after injection (a mean (±SD) BCVA improvement from LogMar 0.25 (±0.60) to LogMar 0.21 (±0.62)).2
“Clinical and real-world use of JETREA® continues to show that patient selection is paramount to ensuring the best clinical outcomes,” said Aaron Osborne, Global Medical Affairs, Pharmaceuticals Franchise Head, Alcon. “We are encouraged by these data and will continue to educate the eye care community that the patients who are most likely to benefit from JETREA® treatment include those individuals with no epiretinal membrane, small macular hole and focal VMT.”
Also during EURETINA, researchers reported data analyses on a patient’s vision-related quality-of-life following treatment with JETREA®. The data demonstrated improvements in vision-related function compared to those who were administered a placebo control injection. There was significant improvement in mean National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) composite scores, which includes 11 visual function subscales and a general health subscale, in the JETREA® arm (3.4) as compared to vehicle (0.7) (P=0.005).3
Finally, results from an evaluation of adverse events (AEs) associated with the treatment of JETREA® reported worldwide between October 2012 and October 2013 indicated that the types of adverse events with JETREA® in clinical practice remain consistent with those observed during the Phase III clinical trials. Additionally, analysis of Phase III data concluded that most AEs were mainly transient in nature, with most resolving before the end of the study.4
“We are continuing to learn more about the safety profile of JETREA® and it is reassuring to see the consistency in the data across real-world and clinical trials,” said Dr. Pravin Dugel, Retinal Consultants of Arizona. “VMT is a serious condition that can lead to loss of vision. As a physician, providing JETREA® as a viable, non-surgical treatment option for appropriate patients helps me with the management of their disease and condition.”
Additional information about JETREA® data presented at EURETINA, as well as other Alcon activities during the congress can be found at www.novartisalconretina.com.
About JETREA® (ocriplasmin) Jetrea is a one-time, non-surgical treatment for people suffering from vitreomacular traction (VMT), a progressive condition that can lead to disabling visual disturbances and loss of central vision and blindness if left untreated. A recombinant form of human protein (plasmin), Jetrea targets the protein fibers that cause the abnormal pull between vitreous and macula. By dissolving these proteins, JETREA® separates the vitreous from the macula, thereby releasing VMT and helping to close the macular hole, if present. JETREA® is approved in the EU for the treatment of VMT, including when associated with macular hole of diameter less than or equal to 400 microns.5
About Alcon Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. Alcon’s three businesses – Surgical, Pharmaceutical, and Vision Care – offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group, with net sales of USD 10.5 billion in 2013. Headquartered in Fort Worth, Texas, USA, Alcon has more than 25,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.
References 1. Kaiser P, et al. Clinical Experience with Ocriplasmin for the Treatment of Vitreomacular Traction and Macular Hole: A Single-Centre Case Series. EURETINA 2014. 2. Szurman P, et al. A single-centre study with ocriplasmin in homogenous group of patients with vitreomacular traction. EURETINA 2014. 3. Lanzetta P, et al. Improved Vision-Related Functionality in Patients with Symptomatic Vitreomacular Adhesion, after Intravitreal Ocriplasmin Injection – Analyses from TG-MV-006 and TG-MV-007. EURETINA 2014. 4. Lanzetta P, et al. The Time Course and Resolution of Key Adverse Events in the Ocriplasmin Clinical Trial Programme. EURETINA 2014. 5. JETREA® Summary of Product Characteristics. ThromboGenics NV. Belgium; January 2013.
Elizabeth Harness Murphy Alcon Global Communications +1 817 551 8696 (direct) +1 585 435 7379 (mobile) [email protected]