AcuFocus said today that it raised another $21 million in an oversubscribed round as it awaits a decision from the FDA on its Kamra device, a corneal inlay designed to treat near vision loss, or presbyopia.
Irvine, Calif.-based AcuFocus said all of its previous backers participated in the round, including HealthCare Royalty Partners, SV Life Sciences, Versant Ventures, Carlyle Group, Accuitive Medical Ventures and Medtronic (NYSE:MDT).
The Kamra device won CE Mark approval in the European Union in 2005. AcuFocus, which raised a $65 million round in 2011, said it plans to use the new funds to extend its reach in Europe and lay the groundwork for commercialization in the U.S. as it works with the FDA on its bid for pre-market approval.
An FDA advisory panel in June issued a mixed verdict on the Kamra inlay, voting that the device is effective but splitting over its safety. The Ophthalmic Devices panel voted 7-1 that Kamra is effective but required chairman Dr. Neil Bressler to break a tie to make the vote 5-4 against on the safety question. The panel was also divided over the Kamra Inlay’s benefits versus its risks, voting 4-3 with 1 abstention that the benefits top the risks.
"We are pleased to have the continued support of all our investment partners as we prepare our business for the next phase of growth," chairman & CEO Jim Mazzo said in prepared remarks. "While we work closely with the FDA on advancing our PMA submission for the Kamra inlay, we are taking steps to expand our sales and marketing organization. We are also focusing significant R&D resources on development of a new presbyopia-correcting intraocular lens that we plan to introduce soon."
"We are confident in the strength and performance of the AcuFocus technology, strategy and management team to deliver proven and reliable solutions for presbyopes who want a fuller range of vision without glasses," added SV Life Sciences chairman emeritus James Garvey.