Recent positive reports about two FDA-approved corneal inlays may yet give this market sector a boost heading into 2017.
Irvine, CA-based AcuFocus was the first to gain FDA approval (April 2015), and while sales of its Kamra inlay have not exactly skyrocketed, the company received a massive vote of confidence in September when legendary private equity New York City-based Kohlberg, Kravis & Roberts invested $66 million.
Kamra is a non-powered implant placed in the non-dominant eye, utilizing the “pinhole effect” to focus light and thus enhance near vision.
The KKR infusion will enable Acufocus to boost its Kamra sales and marketing efforts as well as accelerate the clinical trial for its IC-8 extended depth of focus intraocular lens, which is already approved in Europe.
AcuFocus marks the firm’s first investment in an ophthalmology company. Bill Link, AcuFocus chairman and general partner at Versant Ventures, said the company’s previous investors – Versant, SV Life Sciences, Sightline Partners, AMV Partners, Carlyle, and Medtronic – also participated. The firm previously raised more than $170 million, according to PitchBook.
“We are particularly thrilled that as they have been looking to enter ophthalmology for some period of time that they chose us,” said Al Waterhouse, who recently assumed the COO role at the company. “It’s a real vote of confidence with small aperture technology.” You can hear the entire interview on this OIS Podcast.
Meanwhile, the second corneal inlay entrant in the US, venture capital-backed ReVision Optics of Irvine, CA, which received late-June FDA approval for its Raindrop inlay, recently hired its first sales reps and is slowly rolling out the product in the US. Made of a non-powered hydrogel material, Raindrop is placed under a LASIK-like flap in the non-dominant eye to “bulk” up the cornea and change the patient’s vision. Its AAO booth was very active.
Another Irvine, CA, corneal inlay company is Presbia, which completed enrollment of its pivotal trial in July 2015 for its Flexivue Microlens. The company is now in its FDA-mandated two-year follow-up and is hopeful of achieving final FDA approval in the first half of 2018.
Key features of this implant are that it uses a powered lens like reading glasses and is adjustable as the recipient ages, with the original lens removed and replaced with a higher-powered lens.
Healthegy Content Director Tom Salemi contributed to this report.