- AERIE INITIATES PHASE III REGISTRATION TRIALS OF GLAUCOMA DRUG.
Dosing of the first patients enrolled in Aerie Pharmaceuticals Inc.'s Phase III registration clinical trials of Rhopressa commenced on July 11th. Rhopressa is a novel, once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure in patients with glaucoma or ocular hypertension. Aerie anticipates total enrollment of roughly 1,300 patients in three Phase III registration trials of Rhopressa that will measure efficacy over three months and safety over 12 months. The primary efficacy endpoint of the trials will be to demonstrate noninferiority of IOP lowering for Rhopressa compared to timolol. There will be two trials conducted in the United States, named “Rocket 1” and “Rocket 2,” and one safety-only study in Canada, named “Rocket 3.” Pending success of the studies and regulatory approval, Aerie expects Rhopressa to compete against PGA products as an initial therapy for patients with IOPs of 26 mmHg or below at the time of diagnosis. Pending successful advancement of the Phase III registration studies, three-month efficacy results are expected to be released in mid-2015. If the trials are successful, Aerie expects to submit a New Drug Application filing by mid-2016. Want to know more? Click
- ALCON TO LICENSE GOOGLE “SMART LENS” TECHNOLOGY. In a recent
press release, Novartis announced that its eye-care division, Alcon, has entered into an agreement with a division of Google Inc. to in-license its “smart lens” technology for all ocular medical uses. The transaction with Google[x] remains subject to anti-trust approvals. Under the agreement, Google[x] and Alcon will collaborate to develop a smart lens that has the potential to address ocular conditions. The smart lens technology involves non-invasive sensors, microchips and other miniaturized electronics that are embedded within contact lenses. Novartis's interest in this technology is focused on helping diabetic patients manage their disease and on those living with presbyopia who can no longer read without glasses.
- ZEISS UNVEILS DIGITAL LENS TO MEET THE NEEDS OF MOBILE DEVICE USERS.
For those born in the 1980s and 1990s, digital technology plays a part in almost every aspect of life—and consequently has a significant impact on vision. Fortunately, Zeiss is taking a new approach to addressing the vision needs of this first generation born into digital technology with the Zeiss Digital Lens as well as a consumer marketing approach designed to raise awareness and drive demand for the product. Digital eye strain affects young and old eyes alike, and according to a Vision Council survey, roughly 70% of U.S. adults experience symptoms as a result of digital device use. The Zeiss Digital Lens is a free-form, customized design that integrates the wide, clear distance view that single-vision wearers demand, with a digital boost of focusing power ranging from +0.50 to +1.25. According to Zeiss, this digital viewing area is optimized for digital devices and is reached with minimal head and eye movement. Get additional details
- FDA CLEARS VICTUS FEMTOSECOND LASER PLATFORM FOR LENS FRAGMENTATION PROCEDURE.
Valeant Pharmaceutials International Inc.'s wholly owned subsidiary, Bausch + Lomb, has received 510(k) clearance from the FDA for the Victus Femtosecond Laser Platform for laser-assisted lens fragmentation during cataract surgery. The Victus platform offers a number of different lens fragmentation patterns depending on the cataract grade and user preference. It has also received additional CE marks for Intracor treatment used for flapless intrastromal correction, corneal incisions, penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments. For more information, click
- U.S. PATENT COVERS BROMFENAC FORMULATIONS IN DURASITE.
The United States Patent and Trademark Office has issued a U.S. Patent No. 8,778,999 covering Bromfenac Non-Steroidal Ophthalmic Compositions Formulated in DuraSite. The allowed patent contains both composition and method of treatment claims that will broadly cover all of InSite's bromfenac product candidates, including BromSite (bromfenac 0.075% ophthalmic solution formulated in DuraSite, ISV-303) for the treatment of inflammation and prevention of pain post cataract surgery. Additionally, bromfenac-containing products in InSite's pipeline covered under this patent include: ISV-101 (bromfenac 0.01%—0.04% ophthalmic solution formulated in DuraSite) for the treatment of dry-eye disease, back-of-the-eye BromSite indications, such as the prevention of cystoid macular edema, as well as the combination of bromfenac and dexamethasone-containing products. InSite has successfully completed two Phase III clinical trials of BromSite and plans to file a New Drug Application with the FDA in the second half of 2014. Visit
www.insitevision.com to learn more.
- NOVABAY ANNOUNCES LAUNCH OF I-LID CLEANSER. NovaBay Pharmaceuticals Inc. recently
reported that it will initiate a major marketing campaign and commercialization effort for its new product, i-Lid Cleanser. The campaign will target both optometrists and ophthalmologists, and explain why i-Lid Cleanser is a significant advance in the care of dry eye and blepharitis.
- ABBOTT TO SELL DEVELOPED MARKETS BRANDED GENERICS PHARMACEUTICALS BUSINESS TO MYLAN. In a
statement to the press, Abbott reported that it will sell its developed markets branded generics pharmaceuticals business to Myan for equity ownership of a newly formed entity that will combine Mylan's existing business and Abbott's developed markets pharmaceuticals business, and will be a publicly traded company. The business to be sold operates in Europe, Japan, Canada, Australia and New Zealand and includes approximately 3,800 employees. Abbott does not expect to be a long-term shareholder in Mylan and will retain its branded generics pharmaceuticals business and products in emerging markets. The transaction is expected to close in the first quarter of 2015.
- NICOX'S MARKETING RIGHTS FOR SJÖ EXPANDED IN NORTH AMERICA. Nicox S.A. has acquired the extension of the rights to market Sjö, an advanced diagnostic panel for early detection of Sjögren's syndrome, to all health-care practitioners in North America. This builds on a June 2013 agreement with Immco Diagnostics Inc. to promote Sjö to eye-care specialists in the United States, Canada, Mexico and Puerto Rico. Under the terms of the expanded agreement, Nicox will have exclusive rights to promote Sjö to all health-care practitioners in North America. Nicox will be responsible for all marketing activities using its existing team, while Immco will carry out the test in its CLIA-approved laboratory in Buffalo, N.Y., and be responsible for regulatory activities and reimbursement. To read more, visit