HAIMOVITCH MEDICAL

TECHNOLOGY CONSULTANTS

 
 
By Larry Haimovitch
Medical Device Daily Contributing Writer
LAS VEGAS—This year’s annual meeting of the American Academy of Ophthalmology (AAO; San Francisco) was held here the past few days. The AAO is by far the largest ophthalmic meeting of each year and this year’s attendance was at record levels of about 30,000.
The field of ophthalmology has long been characterized by rapid innovation, especially on the device side of the ledger. Cataract and refractive surgery have been notably innovative for many years, whereas the treatment of glaucoma has generally not been. 
Glaucoma is a chronic degenerative disease, whose incidence increases significantly with age. According to the World Health Organization, it is the second leading cause of blindness in the world. Estimates put the total number of suspected cases of glaucoma at over 60 million worldwide.
Glaucoma medications, which generate about $5 billion in annual sales globally, have long been the mainstay of managing this dreaded disease. However the lack of overt symptoms, multiple drug regimens and an inefficient drug delivery system has contributed to a sub-50% compliance rate. 
This dismal compliance has spawned a plethora of companies with stent-like devices that allow aqueous fluid to flow more readily from the back of the eye through to the front, thereby reducing the major glaucoma symptom of elevated intraocular pressure (IOP).
Minimally invasive glaucoma surgical (MIGS) device companies have responded to this vacuum and the VC community has funded them generously. MDD estimates that five MIGS companies have raised in excess of $0.5 billion privately since their formation. 
Total Private Funds Raised by MIGS Companies
                    AqueSys					$100 million
                    InnFocus					   63
                    Ivantis					 107
                    Glaukos			            	 156
                    Transcend Medical			   89
                    Total					     $ 515 million	
Source: MDD estimates, company published information
In late June, industry leader Glaukos (Laguna Hills, California) became the first MIGS company to raise public funds, as it completed a very successful initial public offering (IPO) of $114 million. 
Glaukos was the first company to commercialize a minimally invasive stent in the U.S., gaining FDA approval in June 2012. Glaukos has achieved tremendous commercial success since its launch, reaching revenue of $21 million and $46 million for calendar years 2013 and 2014 respectively. In the first nine months of 2015, this stellar growth has continued with revenue of $51 million, up 65% over last year’s comparable period.
At a Glaukos sponsored evening event here, several experts shared their positive experiences with the iStent, which sells for about $1000 in the U.S. Thomas Samuelson, MD, Minnesota Eye Consultants (St. Paul, Minnesota) noted that the availability of the iStent ”has given me another tool to treat glaucoma.”  
Samuelson discussed the improving clinical results that Glaukos has reported since its pivotal trial data was released, explaining that there is a learning curve associated with the device and results improve with more surgical cases.
In an analysis of retrospective case series data presented here, five U.S. surgeons performing more than 160 combined cataract and iStent procedures reported mean IOP of 14.6 mmHg at 12 months post-op versus a pre-op mean IOP of 18.2 mmHg.  The mean number of glaucoma medications fell to 0.8 at 12 months, versus 1.5 preoperatively. Importantly, these results are considerably better than those reported in the Glaukos pivotal trial.
An independent study presented in September at the European Society of Cataract & Refractive Surgeons (Dublin, Ireland) by Dr. Tobias Neuhann from Munich, Germany reported iStent in combination with cataract outcomes in 39 eyes.  Patients’ mean IOP was reduced 38% (14.9 mmHg versus pre-op IOP of 24.1 mmHg), with no stent-related adverse events.  Over the same period, patients’ mean medication use fell to 0.3 meds versus a preoperative mean of 1.9 meds. 
John Berdahl, MD, a glaucoma specialist at Vance Thompson VIsion  (Sioux Falls, South Dakota) said that implanting the iStent makes sense for the patients because it reduces the annual cost of glaucoma meds, while it also affords very lucrative reimbursement for the surgeon. He calculated that the addition of an iStent implant to a cataract surgery approximately doubles the surgical fee ($1200 vs. $600). Berdahl has significantly reduced the number of more invasive and generally less successful procedures like trabeculectomy and tube shunts now that the iStent has proven its worth.
Ike Ahmed, MD, a world renowned ophthalmologist from the University of Toronto (Toronto, Canada) said that with the addition of the iStent “the management of glaucoma is changing from medical management to a more surgically-based approach.” Ahmed also reiterated that the clinical results of the iStent have improved as surgeons have gained more experience doing the procedure.
In Canada, the iStent labeling allows for two or three iStents to be inserted, which provides for much better control of IOP. In the U.S., insurers are currently only covering one stent, which is consistent with the FDA label as well. Ahmed typically puts in two stents and sometimes three for patients who are not responding to drugs or other approaches.
While Glaukos has done an exemplary job in pioneering an entire new glaucoma surgical category and owns 100% of the market today, competition is clearly looming. For example, Transcend Medical (Menlo Park, California) recently completed its PMA filing with the FDA and a late 2016 approval appears possible.
The company’s pivotal COMPASS trial was the largest completed, randomized, controlled trial in the MIGS field. It enrolled over 500 patients randomized to either receive the CyPass Micro-Stent after cataract surgery or have no further intervention. The CyPass is placed in the suprachoroidal space, which Ike Ahmed and others believe will produce superb IOP reduction.
Transcend’s international clinical results have been excellent, with strong reductions in IOP and no notable safety issues. Additionally, the company announced in May that the COMPASS study’s primary endpoint was met. Specifically, implantation of the CyPass Micro-Stent with cataract surgery resulted in a 20% or greater reduction IOP from medication-free baseline in a statistically significantly higher proportion of eyes compared to cataract surgery alone at both the two- and one-year medication-free postoperative examinations. MDD’s industry sources believe that the full data set, which will likely be released in 2Q-2016, will be outstanding. 
In an interesting approach presented here, Ernesto Calvo, MD, Clínica de Ojos Orillac-Calvo (Panama City, Panama) used a viscoelastic material in conjunction with CyPass stenting. This small first-in-man study (63 patients total) showed that viscoexpansion reliably enlarges the supraciliary drainage space versus microstenting alone. An increased amount of viscoexpansion showed a trend toward an even better IOP decrease.
Dr. Calvo concluded his talk by saying that “visco-expansion is a technically feasible, repeatable and a safe adjunct to microstent implantation.”
AqueSys (Aliso Viejo, California), which was recently acquired by Allergan  (Dublin, Ireland) for $300 million plus potential future earnout payments, also represents a potential new MIGS market entrant. Prior to its acquisition, AqueSys management had said publicly that it expected to garner 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 a patient population that is refractory to medications.
The XEN stent is placed in the subconjunctival space, where it creates a new patent outflow pathway regardless of where the outflow obstruction is located.
Another exciting glaucoma surgical approach that received significant interest here is Iridex’s (Mountain View, California) tissue-sparing micropulse therapy. It can be performed on the Cyclo G6 laser with the newly-patented MicroPulse P3 (MP3) probe. The Cyclo G6 system includes a glaucoma-dedicated laser along with a family of single use probes, as well as the newly patented MP3 disposable. 
Several talks at the Iridex booth discussed the need for new approaches to treat glaucoma, with current treatment options typically lacking both either safety or efficacy. 
Nathan Radcliffe, MD, from the NYU Langone Medical Center (New York City) reported on his series of 46 patients. Their average IOP drop was 41% (approx. 26 to 15 mm Hg), with no adverse effects. Twelve of the patients required re-treatment to attain these results.
Robert Noecker, MD, from Ophthamic Consultants of Connecticut (Fairfield, Connecticut) commented that this technology offers an “ideal solution” for chronic disease management: (1) Gives physician control of therapy compliance; (2) Efficient; (3) Repeatable; (4) Leaves future treatment options open.
Noecker also disclosed superior results, with 50 patients achieving a 62% reduction in IOP (26 to 9.8 mmHg). Ten patients were retreated.
These two surgeons, as well as others who spoke at the Iridex booth emphasized that the MP3 probe is can very effectively and safely treat patients diagnosed with a range of glaucoma disease states. It can be used in an early stage with a non-compliant patient and it can be used in a later stage when other treatment options have failed.
Iridex has already achieved sigificant commercial success, placing over 75 lasers in the U.S. since its launch in mid-2015. Based upon the enthusiasm of the physicians at the AAO, it appears that this product will become a major product for the company.

2015 American Academy of Ophthalmology

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