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Glaucoma Research Foundation seeks to preserve sight of challenging patient population.
By Larry Haimovitch
San Francisco — The fourth annual “Glaucoma 360 New Horizons Forum,” sponsored by the nonprofit organization Glaucoma Research Foundation (GRF) was held here on Friday, February 6, 2015.
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% being directed to funding glaucoma research. Glaucoma, which is the leading cause of irreversible blindness in the world, afflicts over 70 million globally. It is a chronic degenerative disease, whose incidence increases significantly with aging. A precise cause and successful treatment remains elusive despite tremendous efforts to solve its mysteries.
GRF’s Catalyst for a Cure (CFC) program is a highly innovative approach to glaucoma research. Its goal, to accelerate the pace of glaucoma research, involves bringing together scientists from different backgrounds to work collaboratively to understand glaucoma and find ways to improve treatment and ultimately cure this blinding disease.
In 2012, GRF recruited four scientists from prestigious U.S. academic centers to develop new, specific and sensitive biomarkers to diagnose and manage glaucoma more effectively.
Identifying molecular biomarkers for glaucoma promises many possible benefits. It might have predictive use that could help guide more specific therapy in some glaucoma patients. It might help a glaucoma specialist know when to intervene earlier. In addition, a good biomarker could be used to demonstrate efficacy of drug activity, potentially accelerating federal approval for glaucoma drugs, particularly those that protect the retina and optic nerve.
The CFC research work has been focused on retinal ganglion cells (RGCs) and their subtypes. These cells, which are responsible for transferring information from the eye to the brain, degenerate over time and are believed to be responsible for vision loss from glaucoma.
One of the four CFC “Whiz Kids,” Andrew Huberman, PhD, assistant professor of neurosciences, biology and ophthalmology at the University of California, San Diego provided an excellent overview on the team’s biomarker progress and discussed in detail the group’s work with RGCs.
Huberman described RGCs as the “canary in the coal mine,” adding that “we need to know which patients have RGC loss that will progress, we need to know exactly how fast it will progress, and we need to adjust therapies accordingly.”
He noted that the CFC biomarker initiative has made substantial progress, Identifying which retinal ganglion cells might be the first to be affected in glaucoma. In addition, the group has created new ophthalmic imaging technologies that reveal retinal neuron, vascular cell and metabolic changes with unprecedented detail.
Glaucoma medications have long been the mainstay of managing this dreaded disease. However the lack of overt symptoms (until serious vision loss occurs), multiple drug regimens and an inefficient drug delivery system (eye drops, which often do not make it fully in the eye) has created a longstanding issue of poor compliance. Indeed. a recurrent theme throughout the day was the well- documented sub-50% compliance rate, sometimes euphemistically referred to as the “adherence” rate.
Dismal compliance has spawned a plethora of companies with either drug delivery concepts that could mitigate the compliance issue or stent-like devices that allow aqueous fluid to flow more readily from the back of the eye through the front. Eight drug delivery companies (all privately owned and mostly venture capital-backed) and nine device companies (also private and VC backed) presented here, virtually all noting the chronic compliance problem.
The table below indicates that the amount of capital raised by the five leading minimally invasive glaucoma surgical (MIGS) companies. This enormous sum has been almost entirely from venture capitalists, who are clearly enamored with its market potential.
Their enthusiasm is supported by an in-depth 2014 industry report prepared by the esteemed ophthalmic consulting firm Marketscope (St. Louis). It estimated that the glaucoma surgical devices market would grow at a 41% compounded annual rate over the next five years.
The clear MIGS market leader is Glaukos (Laguna Hills, California), which was founded in 2001 and received FDA approval for its iStent in June 2012. Since launching in late-2012 it has achieved stellar commercial success, racking up $21 million in revenue in 2013 and nearly $45 million in 2014. It now has 52 sales reps. According to CEO Tom Burns, “nearly all current iStent devices are implanted in combined cataract procedures.”
Although clearly the industry leader, Glaukos continues to innovate and is moving forward with two iStent iterations. Its second-generation G2 stent, which is two stents pre-loaded with an auto- injection mechanism, is in the midst of two IDE pivotal trials: one is an expanded phase IDE pivotal trial that is evaluating the safety and efficacy of the iStent implantation in combined cataract procedures; the second approved IDE clinical trial assesses the safety and efficacy of iStent stand- alone procedures in phakic and pseudophakic glaucoma patients. The third-generation product is the iStent supra, which provides a bypass via the supra-choroidal space, for which the company has an expanded phase IDE pivotal study underway.
There have been numerous industry rumors that Glaukos is planning to do an IPO soon. In response to this direct question from MDD, the company would not comment.
AqueSys (Aliso Viejo, California) was founded nine years ago and CEO Ron Bache said that he expected FDA clearance for its XEN Gel Stent in 2016. The expected FDA clearance would be under a 510(k) format for two reasons: (1) There is predicate device to reference and (2) the device can effectively treat patient population that is refractory to medications.
The XEN stent is placed in the “gold standard” subconjunctival space, it creates a new patent outflow pathway created regardless of the where the outflow obstruction is located.
The company’s international clinical data reported to date has been very good. Bache’s presentation showed that in 517 patients treated and followed for three years there was a mean reduction in intraocular pressure (IOP) of 40% from a best medicated baseline and a simultaneous 73% reduction in medications needed to achieve the preop IOP level. Roughly half of XEN implants outside the U.S. in 2014 were in combination with cataract surgery while the other half were standalone procedures.
Transcend Medical (Menlo Park, California), formed a decade ago, appears poised to become the third MIGS stent player to gain FDA approval. Sean Ianchulev, chief medical officer indicated that his company has iterated its product eight times and is looking forward to seeing its 505-patient COMPASS pivotal trial data in the first half of 2015. Later this year, Transcend will likely file its PMA. Its success in lowering IOP has been welldemonstrated in the CyPass non-FDA trial.
InnFocus (Miami), CEO Russ Trenary presented an update on his companyfs MicroShunt product. InnFocus employs a fundamentally different approach to the reduction of IOP than do the other MIGS companies. Its unique approach mimics a trabeculectomy, the most widely-used glaucoma surgical procedure practiced for over 50 years. Trabeculectomy is still regarded as the gold standard in glaucoma surgery as it is by far the most effective surgical approach to lower IOP to 14 mmHg or less, which glaucoma experts believe is the upper IOP threshold required to stop the progression of vision loss.
Its international data has been outstanding, with more than 80% of eyes with IOP . 14 mmHg and an 84% reduction in glaucoma meds to 0.5 meds per patient. Over 70% of patients are entirely off eye drops at three years.
InnFocus is currently conducting the only prospective, randomized controlled MIGS clinical study, comparing its MicroShunt to trabeculectomy. The Phase 1 safety study, which will enroll 75 patients, is in progress while the Phase II safety and efficacy trial will begin later in 2015 and will enroll a total of 439 patients.
Two other MIGS companies presenting here were Ivantis (Irvine, California) and iStar Medical (Isnes, Belgium). The former has treated over 1,800 patients since December 2008 under clinical trial or registry with its Hydrus stent, which scaffolds and dilates through Schlemm’s Canal. The latter has developed the StarFlo which uses a uveoscleral pathway to lower IOP.
Ivantis completed its 100-patient Hydrus ll study and these results were presented at the American Academy of Ophthalmology (San Francisco) meeting in October 2014. It is currently enrolling 558 patients for its U.S. pivotal trial.
iStar has treated in excess of 100 pateints in Europe and is currently in discussions with the FDA about the design of its U.S. IDE trial.
Article by Larry Haimovitch. Source: Medical Device Daily (Vol. 19, No. 30)
Last reviewed on February 17, 2017