Jetrea(TM) receives positive CHMP opinion, would become the first drug to treat sight-threatening vitreomacular traction and macular hole
Pivotal data showed Jetrea significantly resolved vitreomacular traction (VMT) and macular hole compared to placebo at day 28 (p<0.001)
Current standard of care for VMT is surgery or "watchful waiting" associated with further visual impairment that can lead to central blindness,,
- Anticipated approval of Jetreaconfirms Alcon's commitment to providing innovative treatments to address the world's unmet clinical needs in eye care
Basel, January 18, 2013 - Alcon, the global leader in eye care and a division of Novartis, announces the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Jetrea(TM) (ocriplasmin), for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. VMT is an age-related progressive condition that may lead to visual distortion, decreased visual acuity and central blindness, if left untreated. It is estimated that 250,000 to 300,000 patients in Europe suffer from this sight-threatening condition.
Separation of the vitreous, a jelly-like substance within the eye, and the macula, the light-sensitive part at the back of the eye responsible for central vision, occurs as part of the natural aging process and is common in people over the age of 50. If the vitreous fails to detach completely, it can place mechanical stress (traction) on the macula, and can even tear the macula, resulting in a macular hole, if not resolved.
Jetrea, a recombinant form of human protein (plasmin), is administered through a one-time, single intravitreal injection. It targets the protein fibers which cause the abnormal pull between vitreous and macula. By dissolving these proteins, Jetrea releases the traction, and helps to complete the detachment of the vitreous from the macula.
"We are excited to bring this innovative treatment to patients in Europe who live with VMT and macular hole and for whom there has been limited prospect of treatment," said Sabri Markabi, Senior Vice President, Research and Development at Alcon. "This demonstrates Alcon's steadfast commitment to addressing unmet patient needs in the field of eye care. Europe will be the first region outside the US where we expect Jetrea to be approved and our goal is to make this treatment accessible to many more patients around the world."
Currently the only available treatment in the EU is 'observation' or 'watchful waiting' until a patient becomes eligible for surgical intervention at a very late stage of the disease, which includes a vitrectomy (removal of the vitreous from the eye) and repair of the retina (innermost layer located in the back of the eye). However, for many patients this is not a suitable option, and damage to the retina may have already occurred.,
"For patients with VMT and macular hole, activities of daily living, such as reading, driving, the ability to work, use computer screens and overall quality of life are significantly affected," said Professor Yit Yang, Consultant Ophthalmologist, Royal Wolverhampton Eye Hospital, and Visiting Professor, Aston University, UK. "Jetrea represents an important breakthrough for both patients and retinal specialists and represents a paradigm-shift in this area of retinal therapy and clinical practice."
The EU regulatory submission was based on data from two pivotal Phase III clinical trials that evaluated the safety and efficacy of a single administration of Jetrea. Both studies met their primary endpoint and demonstrated that Jetrea successfully resolved VMT and macular hole compared to placebo. At day 28, 26.5% of Jetrea-treated patients achieved resolution of VMT (versus 10.1% with placebo [P<0.001]). 72% of Jetrea patients who achieved resolution by day 28, did so within seven days.
Side effects observed were consistent with the release of traction and intravitreal injections. The most common adverse events with Jetrea in clinical studies (>2%) included: vitreous floaters, photopsia, conjunctival hemorrhage, injection-related eye pain, blurred vision, reduced visual acuity, and retinal edema. These were generally considered mild to moderate and were resolved without complications.
Alcon, a division of Novartis, acquired the rights to commercialize Jetrea outside the United States from the Belgian biopharmaceutical company ThromboGenics, who retains the rights to commercialize the drug in the US. In October 2012, Jetrea was approved in the US for the treatment of patients with symptomatic vitreomacular adhesion (VMA). On January 14, 2013, ThromboGenics launched Jetrea in the US.
The foregoing release contains forward-looking statements that can be identified by terminology such as "would," "anticipated," "commitment," "expect," "hope," "expected," "potential," "will,", "our goal", or similar expressions, or by express or implied discussions regarding potential marketing submissions or approvals for ocriplasmin or regarding potential future revenues from ocriplasmin. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with ocriplasmin to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that ocriplasmin will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that ocriplasmin will achieve any particular levels of revenue in the future. In particular, management's expectations regarding ocriplasmin could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. 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.
Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon 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 pro-forma sales of USD 10 billion in 2011. Headquartered in Fort Worth, Texas, USA, Alcon has more than 24,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.
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 2011, the Group achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 127,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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 Dugel PU, Brown DM, Humayun MS et al. Symptomatic vitreomacular adhesion: diagnosis, pathologic implications, and management. Retina Today 2011;(Suppl):1-14.
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