CyPass Micro-Stent Gets FDA Thumbs Up
The FDA topped off a busy month of ophthalmic approvals last week with its blessing of the CyPass Micro-Stent System for the treatment of glaucoma. CyPass joins the Glaukos iStent as the only FDA-approved minimally invasive glaucoma surgery (MIGS) devices for use in combination with cataract surgery. Alcon/Novartis acquired Transcend, the developer of CyPass, for $240 million in February 2016, and the FDA approval has triggered another $75 million payment.
Shire’s Xiidra Joins Dry Eye Fray
Shire, meanwhile, received FDA approval of Xiidra (lifitegrast) 5%, a twice-daily drop for treatment of dry eye in adults. Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of dry eye, whereas Allergan’s Restasis (cyclosporine) is indicated for increasing tear production in dry eye. Shire expects to launch Xiidra in the US in the third quarter this year.
AMO’s Tecnis Symfony Boosts Premium Channel
The FDA also approved Abbott Medical Optics’ Tecnis Symfony intraocular lens (IOL), giving the premium IOL channel a much-needed boost in the US. This is the first FDA-approved extended-range-of-vision IOL. The FDA also approved four toric models of Tecnis Symfony for astigmatism. The clinical trial submitted with AMO’s application reported that 77% of the people who had the Tecnis Symfony IOL had vision of 20/25 or better without glasses at intermediate vision versus 34% of those with a monovision IOL.
ReVision Raindrop Second Inlay Approved
The month started with ReVision Optics receiving a surprise FDA approval of its Raindrop Near Vision Inlay. The Raindrop is made of a hydrogel material and is implanted in the cornea of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision, following the April 2015 approval of the Kamra, which is sold by AcuFocus.
Mazzo Joins Carl Zeiss Meditec, Changes at AcuFocus
Meanwhile, chairs are shuffling in the corporate suites of medtech companies in ophthalmology. Carl Zeiss Meditec consolidated its ophthalmology businesses in a new unit led by well-known industry veteran James V. Mazzo. Mazzo’s departure as executive chairman and CEO of the aforementioned AcuFocus caused some changes in the c-suite there, too. AcuFocus COO Alan Waterhouse has taken on the title of president, and William Link, PhD, of Versant Ventures assumes the role of board chairman.
Santen-InnFocus Deal Could Top Out at $800 Million
Santen Pharmaceutical Co. and privately held InnFocus, developer of the MicroShunt glaucoma implant, signed an agreement that would allow Santen to acquire InnFocus. Santen will pay $225 million up front and deliver another $225 million to $250 million to InnFocus upon FDA approval. Revenue-based milestones beginning at $100 million could ultimately add another $200 million to $300 million, thus making the total deal value as much as $700 million to $800 million.