ClarVista is a privately held, clinical- and commercial-stage ophthalmology device company concentrating solely on the development of the Harmoni modular intraocular lens (IOL) system. While surgical instrumentation and biometry devices have rapidly progressed and improved in the past decade, the fundamental design of the IOL has not. Surgeons (and patients) have, therefore, come to tolerate unpredictable outcomes and potential complications (such as posterior capsule opacification). ClarVista attributes the challenge of ensuring a predictable lens position to the movement encountered during phacoemulsification procedures with traditional IOLs. Couple unpredictable lens positions with the added difficulty of IOL calculations in the almost 20 million people in the US who have undergone refractive surgery and “refractive outcomes will continue to be a challenge,” President and CEO Paul McLean said.
The Harmoni IOL system proposes to improve and/or eliminate these difficulties. Its two-component system features a base component and an optic component with the former providing a predictable platform inside the capsular bag to securely receive the optic component using traditional surgical tools and techniques.
The system offers the flexibility of exchanging the optic component if necessary; both the fixed base and the optics comprise hydrophobic acrylic polymers, injected through a 2.2- to 2.4-mm clear corneal incision. The design allows for the optic to be exchanged without disrupting the capsular bag; it can be rotated to optimize astigmatism correction as well.
First-in-human trials enrolled 31 patients who were followed for one year. These initial studies were completed in 2013–2014. This year, the company completed its Series B financing, received CE mark certification, received its first two US patents, and started enrollment in a series of trials that will be used to support the Harmoni’s US approval pathway. ClarVista anticipates seeking approval to initiate a US pivotal trial within the next “couple of years,” McLean said.
In its initial multicenter randomized trials on 31 patients with bilateral cataract, patients were randomized to the Harmoni lens system, and a “market leading control IOL” in the other eye. If/when the surgeon believed better refractive outcomes could be achieved in the Harmoni eye, surgeons performed optic exchanges. Results indicated no serious device-related adverse events. All implant procedures were successful, and surgeons noted the system remained stable during the phaco process and “moves much less than traditional IOLs,” McLean said. The optic is easily exchanged in cases of postop refractive residual error, and vision easier to optimize, according to the investigators.
ClarVista noted no new capital investment or reimbursement codes will be needed to use the Harmoni system.
ClarVista Medical is clinical stage, ophthalmic device Start-up Company focused on the development of the HARMONI modular intra-ocular lens system to optimize vision in the setting of cataract surgery.