Business in Brief
It’s been a busy summer in the ophthalmic business space…
Ruth Steer |
- Carl Zeiss Meditec AG made two big announcements. One, they’ve consolidated their ophthalmology activities into a single strategic business unit, and two, they’ve recruited Jim Mazzo to lead it. As the Global President of Ophthalmology, Mazzo will oversee both the new unit and CZM’s US Sales and Service Center.
- Mazzo joined CZM from AcuFocus, who were quick to announce his replacements: Andrew Waterhouse as president and COO, and William Link as Chairman of the Board.
- A deal – potentially worth up to $800 million – has been struck to allow Santen to acquire InnFocus, the manufacturer of the MIGS MicroShunt device.
- The second MIGS device is now available for the US market with the FDA approval of Alcon’s CyPass MicroStent System.
- The FDA has approved Shire’s lifitegrast ophthalmic solution 5%, twice-daily drops for the treatment of the signs and symptoms of dry eye in adults, the Raindrop Near Vision inlay, plus AMO’s Tecnis Symfony IOL (and four toric variants of the IOL).
- Pixium Vision’s epiretinal implant – the IRIS II bionic vision system – receives CE mark certification, and its long-term performance continues to be evaluated in several centers across Europe.
- Twenty-four month follow-up data from the Phase IIIb OASIS clinical trial that evaluated the efficacy and safety of ocriplasmin in patients with symptomatic vitreomacular adhesions have now been published. The study authors concluded that “the OASIS trial demonstrates the long-term efficacy and safety of ocriplasmin, providing improved resolution of symptomatic VMA compared with previous phase III trials with no additional safety signals identified.”
- Clearside Biomedical announced additional results from their Phase II TANZANITE trial (NCT02303184). Patients (n=46) with macular edema and retinal vein occlusion were randomized to receive either Zuprata (Clearside’s proprietary triamcinolone acetonide formulation) and aflibercept, and aflibercept alone. Over a three month period, 78 percent of patients who received dual therapy required no additional treatment, whereas 30 percent of patients in the aflibercept-only arm did (p=0.003). Clearside hope to commence a Phase III clinical program in early 2017.
