Positive phase II data highlights benefits of Alcon's RTH258 for patients with neovascular (wet) age-related macular degeneration - Seite 2

"Alcon is deeply committed to addressing unmet patient needs in retina, and RTH258 demonstrates the potential to improve visual outcomes and reduce the treatment burden for patients with wet AMD," said Sabri Markabi, Senior Vice President, Research & Development for Alcon. "We have initiated our Phase III study program based on the encouraging results we received from the Phase II studies with RTH258."

RTH258 Phase III Study Program Initiated
With these positive Phase II results, Alcon has initiated its Phase III clinical study program to evaluate the efficacy and safety of RTH258 versus aflibercept in patients with wet AMD. As part this innovative study program, Alcon expects to enroll approximately 1,700 patients in more than 50 countries worldwide. The primary objective of the first Phase III study is to compare the efficacy of RTH258 3mg and 6mg versus aflibercept 2mg, with the mean change in BCVA, from Baseline to Week 48 as the primary endpoint. The second study within the Phase III trial program will also compare the efficacy of RTH258 versus aflibercept, and is expected to commence in 2015. Patients participating in the Phase III studies will be dosed every three months with RTH258, while a bi-monthly-dosing regimen will be followed for those patients considered unsuitable for a quarterly dosing schedule due to disease activity. Aflibercept will be dosed according to its approved label. Please visit www.clinicaltrials.gov for further details about the RTH258 Phase III clinical trial program.

AMD is a leading cause of severe vision loss in people over age 50,[1],[2] and the United Nations estimates that it impacts 25 to 30 million people worldwide.[3] AMD occurs when the center of the retina, known as the macula, deteriorates leading to gradual loss in central vision.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "potential," "expected," "promising," "potentially," "committed," "encouraging," "to evaluate," "expects," "will," or similar terms, or by express or implied discussions regarding potential marketing approvals for RTH258, or regarding potential future revenues from RTH258. 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 RTH258 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that RTH258 will be commercially successful in the future. In particular, management's expectations regarding RTH258 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.