Ivantis today said it added a $25 million tranche to its now $71 million Series B round as the Irvine, Calif.-based company looks to bring its miniature glaucoma scaffold to the U.S. market.
The new funding should be sufficient to take it through the FDA approval process for the Hydrus micro-stent Ivantis is developing for what it estimates to be a 700,000-patient market. The device is already being used in some international markets; in the U.S., Ivantis is staging Phase 3 trials with a projected enrollment of 800 patients age 45 or older, under the direction of a principal investigator with the Eye Institute of Utah and a target completion date in 2016, according to the National Institutes of Health.
Many glaucoma patients suffer from a blockage and a collapse of the eye’s natural outflow pathway, which functions to drain aqueous humor from between the lens and cornea. The blockage can increase pressure with eventual nerve fiber layer damage; glaucoma trails only cataracts as the leading cause of blindness. Standard treatment involves medicated eye drops, which can be ineffective if patients do not adhere to the treatment regimen. Other options include removing the block surgically or inserting a tube to relieve the fluid pressure, both of which carry risks.
Roughly the size of an eyelash, the Hydrus device is inserted via a minimally invasive, microsurgical procedure and is designed to reduce eye pressure by reestablishing the patient’s natural outflow pathway. Fabricated from nickel and titanium, the device creates a large opening through the traditional source of flow blockage, then dilating and scaffolding the conventional exit pathway.
Ivantis has raised $88.3 million since its 2007 launch, including a pair of prior Series B tranches under CEO Dave Van Meter, who previously led strategic marketing for Abbott Vascular. Foresite Capital is the newest company to invest in Ivantis, alongside prior backers New Enterprise Associates, Delphi Ventures, Ascension Ventures, Vertex Ventures, GBS Ventures, EDB, and MemorialCare Innovation Fund.
"The minimally invasive glaucoma surgery (MIGS) space is 1 we have followed closely for several years, but until now have not seen the right technology to invest our capital in," Foresite Capital CEO Jim Tananbaum said in prepared remarks. "Ivantis is developing an unprecedented body of Level 1 Clinical trials to validate the technology, and that sound clinical data will carry the day in this space."
Two other California companies developing devices for similar purposes include Glaukos Corp. of Laguna Hills, which won FDA approval in June 2012 for its iStent glaucoma device; and Transcend Medical of Menlo Park, which at last report had more than 1,000 glaucoma patients enrolled in trials of its CyPass micro-stent.
"In the last few years there has been almost an exponential increase in the number of literature articles dedicated to the novel glaucoma surgical devices," Dr. Malvina Eydelman, head of the FDA’s ophthalmic devices section, said last February at a workshop in Washington. "However, it comes to minimally-invasive glaucoma surgery devices, we still have more questions than we have answers."