HAIMOVITCH MEDICAL

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Meeting gathers latest advances in glaucoma treatments in one place


By Larry Haimovitch

Medical Device Daily Contributing Writer

February 2016

SAN FRANCISCO – The fifth annual Glaucoma 360-New Horizons Forum, sponsored by the non-profit organization Glaucoma Research Foundation (GRF; San Francisco), provided a showcase for the future of new treatments for this disease, which is the leading cause of irreversible blindness in the world, afflicting more than 70 million people globally.

GRF is a national non-profit organization that funds glaucoma research worldwide. Since its founding 35 years ago, over $50 million has been raised, with 85 percent being directed to funding glaucoma research.

GRF’s Catalyst for a Cure program is a highly innovative approach to glaucoma research. Its goal, to accelerate the pace of glaucoma research, has brought together scientists from different backgrounds to work collaboratively to understand glaucoma and find ways to improve treatment and ultimately cure this blinding disease. From presentations here, it is clear that major strides have been made in the quest to develop new, specific and sensitive biomarkers to diagnose and manage glaucoma more effectively.

For many years, the annual global glaucoma market, currently estimated at approximately $5 billion was notably “sleepy,” with minimal innovation on both the pharmaceutical and device side. No significant new classes of pharmaceutical agents have been approved since the first prostaglandin drug (lantoprost) gained clearance in 1996. Meanwhile the device side has languished with older laser technologies (trabeculoplasty) and relatively ineffective and/or highly risky surgical procedures (trabeculectomy and shunts) being the mainstays in treating drug resistant or non-compliant patients.

The FDA approval of the Glaukos (Laguna Hills, California) iStent in June 2012 has dramatically changed the device/ surgical landscape. iStent’s revenue in 2015, in just its second full year of commercialization, exceeded $71 million, a 57% increase over 2014 revenue. Moreover, management has already predicted another banner year for 2016, with annual revenue expected to mushroom another 28%.

The iStent, a hair-sized device that is almost exclusively implanted during cataract surgery, represents the first in the wave of several new likely minimally invasive glaucoma surgery devices (MIGS) FDA approvals. On the near term horizon is Aquesys (Aliso Viejo, California), which was acquired in October 2015 by Allergan (Dublin, Ireland) for $300 million plus potential future earnout payments. Prior to its acquisition, AqueSys management had said publicly that it expected to garner a 510(k) FDA clearance for its XEN Gel Stent in 2016.

The COMPASS pivotal trial data for the Cypass micro-stent, developed by Transcend Medical (Menlo Park, California), will likely be released in May at the annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS; Reston, Virginia). MDD’s sources believe that Transcend will likely be invited to an FDA Ophthalmic Advisory Panel meeting in either late Q2-2016 or Q3-2016.

In his presentation “New Horizons in Glaucoma Devices,” Steven Vold, MD, Vold Vision (Fayetteville, Arkansas) said that “MIGS is transforming the way we treat combined cataract and glaucoma.” He spoke highly of the Cypass stent, saying that it provides “novel aqueous outflow enhancement using supraciliary versus trabecular stenting.” 

Ivantis (Irvine, California) and InnFocus (Miami) are also contenders and expected to be FDA approved later.  The former company completed enrollment in April 2015 for its HYDRUS IV clinical trial, which enrolled 556 patients, the largest MIGS study ever. It is currently in the FDA mandated two-year followup period and could reach the domestic market in 2018.

The latter, which presented here, is rapidly enrolling for its 412 patient pivotal trial, which will be completed in the next 12 to 18 months. It will compare the MicroShunt to the gold standard trabeculectomy.  Importantly, the company has recently been informed by the FDA that they will require only a one-year follow-up to the pivotal trial data, thereby shortening the path to U.S. commercialization. Specifically, the company could be approved sometime in 2018 or 1H-2019.

CEO Russ Trenary told the packed GRF audience that his company’s mission is to become “the first FDA approved minimally invasive stand alone procedure for mild, moderate, and severe stage primary open angle glaucoma (POAG), that lowers and sustains IOP under 15 mm Hg, and completely eliminates eye drop medications in most patients.” Over 250 patients have now been treated to date in clinical trials with the device in Canada, France, Japan, the Netherlands, Spain, Switzerland, the Dominican Republic and the U.S.

He also noted that whereas his competitors are focused solely on the “niche” cataract with glaucoma market, InnFocus’s MicroShunt will be the first and only MIGS device to provide treatment for all stages POAG, which Trenary stated was 59% of the total glaucoma market.

The MicroShunt is made of a unique, bio-inert material which is ultra-stable and does not degrade. The procedure utilizes the 50-year proven trabeculectomy aqueous drainage pathway, which differentiates it from the Schlemm’s canal and suprachoroidal-based MIGS pathways ultilized by its competitors.

The combination of these two attributes is proving to be valuable. To wit, an article in the February 2016 issue of the Journal of Glaucoma, the 22 patients studied had an average pre-surgical fully medicated intraocular pressure (IOP) of 23.8 mm Hg.  Three years after being treated with the MicroShunt the average IOP was reduced 55% to 10.7 mm Hg.  Very impressively, over 80% of the 22 patients achieved an IOP under 14 mm Hg. Sixty-four percent of patients did not require any glaucoma medication at the third year of the study.

The lead author and principal surgeon for the study, Juan Batlle, MD, Centro Laser (Santo Domingo, Dominican Republic) said that "these results show not only the potential effectiveness but the possibility for sustainability of low IOP with the InnFocus procedure.”

Several other privately-funded glaucoma surgical devices companies presented here. The technologies included a shunt that directs aqueous fluid to the tear film, (MicroOptx, Maple Grove, Minnesota), goggles that are worn by the patient to help normalize the difference between IOP and cerebrospinal fluid (Equinox LLC, Sioux Falls, South Dakota), a surgical blade, engineered for the anatomy of the trabecular meshwork and Schlemm’s Canal, that restores the natural pathway and aqueous flow (New World Medical, Rancho Cucamonga, California) and a very rapid, minimally invasive micro sclerostomy procedurethat is showing promising early data (Sanoculis, Kiryat Ono, Israel).

As a positive consequence of all this new technology coming to the market, the venerable market research firm Market Scope is forecasting that the global glaucoma device market will soar from $354 million in 2015 to $1.1 billion in 2020. This represents a hefty compound annual growth rate of  26%.

The compliance rate for glaucoma medications is dismal, with less than 50% of patients still using drops after one year and 60% of glaucoma patients not using their drops properly. This so called “lack of adherence” is strongly correlated with vision loss and therefore there is keen interest in new methods of glaucoma drug delivery.

Therefore it was no surprise that there are myriad companies working in this area, with several of them presenting here. These included Envisia Therapeutics (Research Triangle Park, North Carolina), whose comprehensive approach to ocular drug delivery includes an intracameral extended release bio-degradable prostaglandin (travprost) release that has completed a successful Phase 2a trial; Forsight Vision5 (Menlo Park, California), which has developed a non-invasive ocular insert that is impregnated with a prostaglandin (bimatoprost) and has completed a successful Phase 1 trial; Graybug (Baltimore, Maryland), which uses a very small needle injector to deliver a biodegradable, biocompatible and bioabsorable encapsulated drug into the eye. It expects to begin its human glaucoma trial in 2017; Selkie Therapeutics (Pittsburgh, Pennsylvania), has developed an eye drop that forms a stable gel and releases for one month in the eye. Animal trials to date are promising.

Other drug delivery participants included two publicly-owned companies Ocular Therapeutix (Bedford, Massachusetts) and Ohr Pharmaceuticals (New York). The former is developing an intracanalicular (via the punctal duct) using travoprost which is in Phase 2 while the latter, mainly targeting macular degeneration, has developed a micro-particle technology that is targeting steroid induced glaucoma.

Glaucoma 360 - New Horizons Forum 2016

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