- MOBIUS RECEIVES FINAL APPROVAL FOR MITOSOL FROM FDA. Mobius Therapeutics, LLC can now start marketing and production efforts for the platform product Mitosol, now that it has received final approval for the drug from the FDA. This initial indication is for the use of Mitosol in glaucoma surgery. According to the company, Mitosol provides a new system for delivering a precise dose of its active ingredient, mitomycin-c, to ophthalmic surgeons for use in procedures without any change to their current technique. Click
here to learn more.
- FIRST PATIENT DOSED IN PHASE 2a CLINICAL TRIAL OF ATS907 FOR THE REDUCTION OF IOP. Altheos, Inc. has announced the dosing of the first patient in a Phase 2a clinical trial of its lead investigational candidate, ATS907, a Rho kinase (ROCK)-selective inhibitor in development as a next-generation eye drop for the reduction of elevated IOP in primary open-angle glaucoma and ocular hypertension. The study uses a two-stage adaptive design and is intended to evaluate a number of different doses of ATS907 ophthalmic formulation and to provide preliminary information on safety, tolerability and efficacy (reduction in intraocular pressure) following 28 days of administration. ATS907 is one of a series of ROCK inhibitor compounds licensed from Asahi Kasei Pharma. In other company news, Altheos has raised an additional $12.5M in its Series A financing, bringing the total to $32.5M, which will enable completion of a robust Phase 2 clinical program. For additional information, click
- HEIDELBERG UNVEILS NEW IMAGING MODALITY. Heidelberg Engineering is launching MultiColor Scanning Laser Imaging as a new dimension in multi-modality fundus imaging with the Spectralis product family. The company says that MultiColor imaging uses multiple laser colors simultaneously to selectively capture and display diagnostic information originating from different retinal structures within a single examination. Spectralis with MultiColor will initially be available in Europe and is expected to be available in the United States and other countries later this year. Get more information at
- NEW PORTABLE OPTHALMIC CAMERA AVAILABLE FROM EYEQUICK. The EyeQuick Digital Ophthalmoscope Camera, recently cleared by the FDA, captures photographs and videos with the press of a button. EyeQuick, LLC says its new portable ophthalmic retinal and anterior segment camera gives clinicians an affordable means to document pathology in any setting and on patients of any age or physical capability. Images are instantly viewable on the built-in LCD screen and at any time can be exported via the EyeQuick's USB port. Distributed by EyeQuick and manufactured by Miller Technical Services, the EyeQuick Digital Ophthalmoscope Camera comes with a rechargeable battery and a sturdy metal carrying case, and at 13 ounces and 9 inches, weighs about as much as a full can of soda and stands about as high as two stacked soda cans. Learn more at
- FDA APPROVES ZIOPTAN FOR REDUCING IOP. According to a Santen Pharmaceutical Co., Ltd.
press release, Merck & Co., Inc. received the approval of Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution from the U.S. FDA. The approval was based on efficacy and safety results from five controlled clinical studies of up to two years in 905 patients. Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies. Zioptan, approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was shown to have powerful IOP-lowering effects in clinical studies. In April 2009, Merck and Santen entered into a worldwide licensing agreement for tafluprost that defined commercial rights between the two companies with regard to tafluprost in various territories. Merck anticipates that Zioptan will be available to customers in the United States in March.
- EYETECH ACQUISITION ANNOUNCED. In a recent
press release, Valeant Pharmaceuticals International, Inc. announced that it has agreed to acquire ophthalmic biotechnology company Eyetech Inc. for an upfront payment and potential future milestones that total significantly less than two times sales. Eyetech currently markets the anti-VEGF inhibitor Macugen, approved for the treatment of wet AMD, in the United States.
- COUNTERFEIT AVASTIN FOUND. The FDA has issued a statement warning about a counterfeit version of the injectable cancer drug Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version of the drug does not contain the active ingredient bevacizumab, which may have resulted in patients not receiving needed therapy. The FDA sent letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin. Packages or vials may be counterfeit if they are labeled with Roche as the manufacturer and/or display batch numbers that start with B6010, B6011 or B86017. Learn more at the FDA's
website. The agency will continue to evaluate this situation and will provide updates. See Roche's
statement about this counterfeit medicine.
- SD-OCT USED FOR FIRST TIME IN ELEPHANT CATARACT SURGERY. In November 2011, a team of specialists from the North Carolina State University College of Veterinary Medicine, led by Dr. Richard J. McMullen Jr., assistant professor of ophthalmology, performed cataract surgery on the North Carolina Zoo's longest resident, a 38-year-old African elephant named C'sar. The four-hour procedure, which used Bioptigen's Envisu R2300 ophthalmic imaging system, was the fifth cataract surgery performed on an elephant anywhere in the world. It also marked the first time a spectral-domain optical coherence tomography imaging system was used on an elephant.
After suffering from deteriorating vision in both eyes caused by cataracts since 2010, C'sar was taken out of exhibit and has been sheltered within his barn and paddock since March 2011. Because of damaged tissue caused by the cataract, C'sar's eye would not have provided enough support for the specially created artificial lens Dr. McMullen had intended to implant. However, removal of the cataract does leave him with improved, though farsighted, vision. The zoo staff looks forward to allowing the pachyderm to return to his exhibit once the weather and his recovery allows it, but if he has problems safely negotiating the space, the keepers and veterinary staff will discuss the possibility of operating on his other eye with the hope of further improving his vision. Read more about C'sar's story