15 Mar 2017
Ireland-headquartered company completes shareholder rights issue to sure up finances while pivotal US study is completed.
Presbia, a Nasdaq-listed company that is looking to introduce its novel lens implant treatment for presbyopia to the US market, has raised $10.8 million in a shareholder rights issue.
Coming two years after the Ireland-headquartered firm completed a $36.8 million initial public offering (IPO), the cash injection will be used to support a trial of the technology in US clinics that it is hoped will result in pre-market approval from the US Food & Drug Administration (FDA).
Presbia has developed a miniature lens it calls “Flexivue” that can be implanted directly into a patient’s cornea after a femtosecond laser procedure to create a "pocket". The hydrophilic lens helps correct visual defects caused by presbyopia – the long-sightedness effect that tends to develop in middle-age as a result of the “stiffening” of muscles around the eyeball.
While the company already has “CE Mark” approval to market the technique across Europe and similar permissions in countries including South Korea, Australia, and Brazil, it appears to have been unable to convert that into any meaningful sales.
The most recent quarterly financial results available for Presbia showed a $4.3 million loss on negligible sales revenues for the three months ending September 30, 2016, with cash assets dwindling to $10.5 million.
Formed from the combination of Visitome and PresbiTech back in 2008, the company has a complex structure involving related parties based in the US, The Netherlands and the Cayman Islands, as well as Ireland.
Pivotal US trial
Presbia has historically purchased all its microlenses from a supplier in Israel, although with that deal due to have expired in January, the company suggested that it would be able to ramp lens production at its own facility in Irvine, California, if necessary.
The pivotal US trial of Presbia’s technology has been ongoing since late 2015, with nearly 350 patients enrolled in a second-stage study of the lens implant’s safety and effectiveness.
“We are targeting submission of our final pre-market approval (PMA), containing 24-month data on 300 subjects, to the FDA in the fourth quarter of 2017,” reports the company in its US Securities & Exchange Commission (SEC) filings.
“We are targeting PMA approval of our microlens between the first quarter and third quarter of 2018,” it added. “We are also targeting submission to the FDA of a final report with 36-month data on these 300 subjects between the second and the fourth quarter of 2018.”
Korea results ‘excellent’
While the US trial is ongoing, Presbia claimed last year that a smaller-scale trial in South Korea had yielded “excellent” results, with the 14 subjects treated at the BalGeunSeSang (BGSS) Eye Clinic said to have gained an extra five lines of near vision.
“This means a person who could barely read a newspaper sub-headline prior to surgery, can now read the small print on a prescription eye drop bottle without the use of reading glasses,” said the firm.
Presbia’s CEO Todd Cooper said at the time that the results would support the company’s introduction of commercial activities in the country, where LASIK visual correction has proved particularly popular.
Key investors in the company include the venture firm Orchard Capital via its founder Richard Ressler, who filings reveal owned around 60 per cent of Prebia’s ordinary shares prior to the latest rights offering.
The rights offering had initially been hoped to raise $13.5 million at a price of $3 per share – down significantly on the IPO launch price of $10 in February 2015, since when the company has traded on the Nasdaq exchange under the ticker symbol “LENS”.