Novartis demonstrates leadership in ophthalmology with new products and over 40 abstracts at EURETINA
- Retrospective analysis of US claims data suggests risk of endophthalmitis is 65% higher in patients treated with aflibercept than those treated with Lucentis[1]
- Presentations discuss safety of Jetrea® in clinical practice and importance of appropriate patient selection[2],[3]
- Alcon introduces new array of vitreoretinal surgical products designed to treat retinal disease and improve patient outcomes
The digital press release with multimedia content can be accessed here:
Basel, September 13, 2014 - New data on Lucentis® (ranibizumab) and Jetrea® (ocriplasmin) from over 40 abstracts, as well as new surgical retina products, were presented at this year's EURETINA congress in London. The new data and products continue to highlight Novartis commitment to ophthalmology, and underscore its dedication to continually find new ways to protect and enhance eye health for patients.
Among the Lucentis highlights at EURETINA was the retrospective analysis of data from a US claims database. The database offers the first direct comparison of the risk of developing a condition known as endophthalmitis for patients with wet age-related macular degeneration (wet AMD) treated with injections of Lucentis or aflibercept in the eye. A total of 253,647 Lucentis injections (in 54,551 patients) and 179,147 aflibercept injections (in 39,389 patients) were eligible for the analysis. The results suggest that the risk of endophthalmitis is 65% higher following treatment with aflibercept than treatment with Lucentis. As with all retrospective analysis of important real word data, such results should be interpreted with caution and where feasible, verified by double-blind randomized controlled trials[1].
"The new Lucentis data at EURETINA supports its well-characterized and long-established safety profile and provides further support for its role as the only anti-VEGF therapy licensed for five ocular indications," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals.
Alcon presented further efficacy and safety data for the use of Jetrea at EURETINA. Two presentations highlighted real-world clinical experience; one of which, conducted at the Cleveland Clinic's Cole Eye Institute, demonstrated a high rate of release and closure of vitreomacular adhesion (VMA) and macular hole (MH), highlighting the critical importance of appropriate patient selection with the use of this treatment[3]. Data discussions from a second presentation indicate further evidence of a post-authorization safety profile is consistent with that observed during the trials[2]. Researchers also discussed vision-related quality-of-life experienced by patients following treatment with Jetrea. Analysis indicates that these patients displayed better improvements in their vision-related function compared to those who were administered a placebo-controlled injection[4].
Alcon also introduced several new instruments to its surgical vitreoretinal portfolio during EURETINA: the ULTRAVIT® High Speed Vitrectomy Probes in various gauge sizes, 27+ vitrectomy packs with a full complement of 27-gauge instrumentation, as well as the FINESSE(TM) Flex Loop. These new technologies are designed to help ophthalmic surgeons deliver a higher level of precision and efficiency during vitreoretinal surgery. Vitreoretinal surgery is the surgical removal of the vitreous gel from the middle of the eye. The procedure allows ophthalmic surgeons to better access the back of the eye when treating retinal diseases.
The ULTRAVIT® High Speed Vitrectomy Probes reduce pulsating traction on the retina, which can frequently cause tears and post-operative complications[5],[6]. The 27+® gauge system and instrument portfolio is designed to give surgeons exceptional access to the small tissue areas of the eye during complex retinal surgery procedures[7]. The FINESSE(TM) Flex Loop is the newest member of Alcon's Grieshaber® instrumentation portfolio, and is designed to create an edge on the retinal membrane to help peel and remove it during retinal surgery[8].
"Alcon's goal is to continually address the unmet medical needs of our patients," said Sabri Markabi, Chief Medical Officer and Senior Vice President, Research and Development, Alcon. "The introduction of new surgical vitreoretinal instruments and, our focus on Jetrea as a viable option to address the sight-threatening disease of vitreomacular traction, are key examples of our dedication to providing meaningful treatments intended to improve the vision and overall quality of life of patients."
Novartis and its eye care division, Alcon, offer the industry's most comprehensive portfolio of quality surgical and pharmaceutical retina products available to deliver the best treatment outcomes to patients.
About Lucentis® (ranibizumab)
Lucentis was designed to save sight and has demonstrated transformational efficacy with individualized dosing in its licensed indications. As an antibody fragment with a short systemic half-life, Lucentis was specifically designed, developed, formulated and licensed for ocular conditions, and is manufactured to the highest standards for intra-ocular use.
Lucentis is licensed in more than 100 countries, for the treatment of wet AMD, visual impairment due to DME and for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. Also, Lucentis is licensed in more than 70 countries for the treatment of patients with visual impairment due to CNV secondary to pathologic myopia (myopic CNV). In most countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.
Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 2.4 million patient-treatment years of exposure since its launch in the United States in 2006.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.
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 has been shown to provide early resolution of VMT, including when associated with macular hole of diameter less than or equal to 400 microns[8].
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "suggests," "introduces," "commitment," "dedication," "may," "indicate," "introduced," "goal," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Lucentis and Jetrea, or regarding potential future revenues from any of Lucentis, Jetrea, ULTRAVIT High Speed Vitrectomy Probes and FINESSE Flex Loop. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Lucentis or Jetrea will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that any of Lucentis, Jetrea, ULTRAVIT High Speed Vitrectomy Probes and FINESSE Flex Loop will be commercially successful in the future. In particular, management's expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
References
[1] Kelly S, et al. Endophthalmitis following ranibizumab or aflibercept treatment in patients with neovascular age-related macular degeneration: a retrospective US database analysis. EURETINA 2014.
[2] Stalmans P, et al. Ocriplasmin in the Clinical Setting: An Overview of Post-approval Safety Outcomes. EURETINA 2014.
[3] Kaiser, et al. Clinical Experience with Ocriplasmin for the Treatment of Vitreomacular Traction and Macular Hole: A Single-Centre Case Series. EURETINA 2014.
[4] 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.
[5] Rizzo S, et al. Comparative study of the standard 25-gauge vitrectomy system vs. the new ultra-high-speed vitrectomy system. Retina Today. September Insert, 2010.
[6] Teixeira, et al. An experimental protocol of the model to quantify traction applied to the retina by vitreous cutters. IOVS. 2010 Aug:51(8):4181-4186.
[7] Dugel, PU, Abulon DJ, Dimalanta R. Tissue attraction laboratory comparison of 7500 CPM Dual-Pneumatic Vitrectomy Probes. Poster Presentation, 2014.
[8] JETREA® Summary of Product Characteristics. ThromboGenics NV. Belgium; January 2013.
# # #
Novartis Media Relations
|
Central media line : +41 61 324 2200 |
|
|
Eric Althoff Novartis Global Media Relations +41 61 324 7999 (direct) +41 79 593 4202 (mobile) |
Sandra Waite Novartis Pharma Communications +41 61 324 0589 (direct) +41 79 912 7024 (mobile) |
Elizabeth Harness Murphy
Alcon Global Communications
+1 817 551 8696 (direct)
+1 585 435 7379 (mobile)
e-mail: [email protected]
For Novartis multimedia content, please visit
www.thenewsmarket.com/Novartis
For questions about the site or required registration, please contact: [email protected].
Novartis Investor Relations
|
Central phone: |
+41 61 324 7944 |
|
|
|
Samir Shah |
+41 61 324 7944 |
North America: |
|
|
Pierre-Michel Bringer |
+41 61 324 1065 |
Stephen Rubino |
+1 862 778 8301 |
|
Thomas Hungerbuehler |
+41 61 324 8425 |
Susan Donofrio |
+1 862 778 9257 |
|
Isabella Zinck |
+41 61 324 7188 |
|
|
|
|
|
|
|
|
e-mail: [email protected] |
e-mail: [email protected] |
||
Copyright GlobeNewswire
Attachment(s)
http://hugin.info/134323/R/1855704/649263.pdf
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: %s via Globenewswire
[HUG#1855704]
