Contact lens specialist Interojo has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its silicone hydrogel (Si-Hy) contact lenses. Interojo is expected to use this clearance to target the global market while strengthening strategic cooperation with overseas corporations.
According to the capital market industry, Interojo received final clearance for its silicone hydrogel contact lenses on the 1st, about four months after filing for FDA 510(k) in Feb.
Silicone hydrogel contact lenses have the advantage of higher oxygen permeability than conventional hydrogel materials, making them suitable for long wear. In major markets such as the United States and the United Kingdom last year, silicone hydrogel contact lenses held a 90% market share, and they have recently been expanding their share in Asia as well.
Interojo secured the clearance after completing clinical trials of its in-house–developed silicone hydrogel contact lenses with 75 subjects at three clinical institutions in the United States. With the FDA clearance granted, authorizations in major countries including Japan and China are expected to speed up.
In addition to the monthly disposable clear lenses that have received clearance, Interojo is also pursuing clearance for daily disposable and color lenses. Clearance for daily disposable and color lenses is expected within this year.
Major global corporations, which control about 85% of the global contact lens market, are optimized for automated mass production centered on clear lenses. Because color lenses require small-lot production across many varieties, Interojo's strategy is to target a niche market. If color lenses are cleared, cooperation with global distributors is expected to make gains in overseas market share more visible.
With the U.S. entry of silicone hydrogel lenses underway, Interojo's earnings growth is also expected to accelerate. On a consolidation basis, Interojo's operating profit in the first quarter of this year was 6.2 billion won, up 186% from 2.2 billion won a year earlier. During the same period, revenue was 30.7 billion won, up 33%, and net profit grew 252% from 1.4 billion won to 5.0 billion won. The share of revenue from silicone hydrogel lenses also increased from 9% to 20%, supporting improved profitability.
An Interojo official said, "This U.S. FDA clearance proves that Interojo's silicone hydrogel lens technology meets world-class standards," adding, "We will simultaneously push ahead with targeting the U.S. market and obtaining authorizations in major Asian countries, and expand our presence in the global market through strategic manufacturing partnerships with global major corporations."