EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/78710
May 2012 LABS Cannulae For Flap Management and Irrigation. Alcon: We estimate that about 10% of submissions require addi- tional data or studies, such as in the case of study replication or where the FDA has a difference between its perceived safety of the drug and the clinical data. EyeWorld: If the FDA does need more data, how much does an addi- tional trial cost? Alcon: Additional trials range from $5-20 million. EyeWorld: How do you decide whether or not to get the additional data? Alcon: Two key factors that drive our decision are: 1) whether the additional data is required for approval or whether it is a post-ap- proval commitment; and 2) where the product fits into the competitive landscape. ISTA: If the FDA requires addi- tional data, companies would need to figure whether the timing and costs fit within their strategic goals and the market needs. If you con- sider the timing from the initial tri- als to the completion of additional trials, market conditions and needs may be vastly different. EyeWorld: Once a drug is in the hands of the FDA, what is the wait- ing process like for those involved? Is it incredibly stressful for months, or are you able to put it out of your mind and focus on other things? Alcon: While we closely moni- tor the regulatory processes, most of our R&D associates are working on multiple projects concurrently, so while one product is awaiting ap- proval, they shift their attention to another project or are preparing for launch activities. ISTA: As with most companies, there are additional priorities occur- ring simultaneously. In order for companies to be successful, we want multiple projects in the pipeline; un- fortunately, even with the best effort and millions of dollars invested, there are no guarantees for approval. EW Editors' note: Dr. Krueger is head of portfolio and project management, Alcon. Mr. Chang is director of product marketing, ISTA Pharmaceuticals, and founding member, Vanguard Ophthalmology Society. Contact information Chang: achang@istavision.com Krueger: Dave Jackson at dave.jackson@alconlabs.com The Global Sight Alliance is a centralized, global portal for the cataract blindness community of NGOs, clinical researchers, ophthalmologists, and other eyecare professionals. Foundation ADVANCING THE WORLD'S VISION T he Global Sight Alliance works with the ASCRS Foundation and was formed with the purpose of centralizing education and communica- tion about the fight against cataract blindness including some of the following: • Volunteer opportunities – similar to the current Missioneyes.net search function, which can match volunteers with organizations looking for help • Evidence-based studies – an online library of key studies and articles that relate to cataract surgery and MSICS in the developing world setting • Blogs and reports from doctors on the front lines – enable volunteers to share their experiences with other interested individuals, as well as to engage newly interested healthcare professionals • Resources for planning support trips – including information and help for those planning a support trip • Educational libraries – including surgical teaching videos and lectures, PPT presentations, and non-scientific published articles • Links to pertinent agencies and other organization's websites • Discussion groups – that use the ASCRS listserv format to facilitate online discussion and advice Visit www.globalsight.org for more information. Name Dept. Address Ci t y Phone# Please Return to Eagle, At tention:Customer Relations State Zip LABS 10201-A TRADEMARK STREET • RANCHO CUCAMONGA • CALIFORNIA 91730 PHONE 909.481.0011 or 800.782.6534 • FAX 909.481.4481 email: goeagle@eaglelabs.com www.eaglelabs.com Yes! Please Send: Catalog Brochures for Refract ive Products,Cannulae, Blades & Knives Samples of the Following: FM 71198 EW ASIK Products Premium LASIK #602-27 Silicone Tip LASIK Flap Irrigator/Squeegee 27 GA x 1" Angled, 7mm bend to tip #602-23 Silicone Tip LASIK Flap Irrigator/Squeegee 23 GA x 1" Angled, 7mm bend to tip Angled silicone tip allows for safe lifting of the flap, silicone sleeve acts as a "squeegee" to remove excess fluid and smooth down the flap to realign gutter. #610-23 LASIK Flap Spatula/Irrigator 23 GA x 1" Angled, 9mm bend to tip #611-23 LASIK Flap Spatula/Irrigator 23 GA x 1" Angled, 4mm bend to tip Non evasive tip allows for safe lifting of the flap and curved angle to smooth the flap during alignment, open end for irrigation. #603-25 LASIK Irrigating Cannula 25 GA x 1" Angled 7mm bend to tip Features 3ea .3m ports used to irrigate the anterior and posterior sides of the flap, smooth angle curva- ture allows for safe flap alignment. © Eagle Laboratories 2012