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 have contributed to a well-studied 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). A breakfast breakout session at OIS@AAO in Las Vegas explored the addition of these devices.
Minimally invasive glaucoma surgery (MIGS) device companies have responded to the compliance vacuum and the venture capital community has reacted with resounding support. Five key MIGS companies are estimated to have raised in excess of $0.5 billion privately since their formation.
Industry leader Glaukos became the first MIGS company to raise public funds, as it completed a very successful initial public offering (IPO) of $114 million in late June. Parenthetically, JP Morgan Chase was one of the lead underwriters.
Glaukos was also the first company to commercialize a MIGS device, the iStent, in the US, gaining FDA approval in June 2012. Glaukos has achieved tremendous commercial success since the product’s launch, reaching revenues 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.
Michael Weinstein, managing director and medical device analyst for JP Morgan Chase, moderated the panel. In his opening comments, Weinstein told session attendees the efficacy of the Glaukos stent appears to be improving as it has become more widely used. He was referring to data presented in September at the meeting of the European Society of Cataract & Refractive Surgeons by Dr. Tobias Neuhann from Munich, Germany. Neuhann’s independent study in 39 eyes reported a 38% reduction in mean IOP, with patients’ mean medication use falling to 0.3 meds versus a preoperative mean of 1.9 meds. These results are notably better than the Glaukos pivotal iStent trial.
Dr. Rick Lewis and Dr. Louis Kantor. Both surgeons quickly pointed out there definitely is a learning curve associated with MIGS devices and that inevitably results will improve with more surgical cases. Lewis, of Sacramento Eye Consultants, noted that the implanting surgeons in the pivotal trial “had no prior experience” with the device and that clearly explained the improving results.
Kantor, director of glaucoma services at the Eugene and Marilyn Glick Institute (Indiana University), who has implanted fewer than 10 iStents so far, noted that he is trying to sort out “who are the best MIGS candidates” among his glaucoma patients. He looks forward to the approval of other MIGS devices, which would provide therapeutic options. “No one device will fit all,” he said.
Lewis agreed, adding that “having options is critical.” He pointed out that a huge issue in managing glaucoma is that it is a very complex disease and therapy must be tailored for each patient.
Both physicians cited the tremendous safety profile of the iStent, saying it also gives them future options if it does not provide the desired IOP reduction. Kantor is looking forward to availability of the Aquesys XEN stent, which could reach the US market in about a year. Lewis commented on the Transcend Medical CyPass device, which could also reach the US market in about one year. (Alcon announced plans to acquire the company this week.) He cautioned that migration might be an issue but indicated that has not been a problem so far. His bigger concern is re-occlusion of the stent after implantation.
Both Drs. Kantor and Lewis also are keen to have the Ivantis and InnFocus devices available to them, though the products are not likely to reach the US market until 2018 (Ivantis) and 2019 (InnFocus). The former company completed enrollment in April 2015 for its HYDRUS IV clinical trial, which enrolled 556 patients, the largest MIGS study ever. The latter, whose device is considered to require the most invasive MIGS procedure, has completed Phase I of its pivotal trial, enrolling 100 patients and is now in Phase II, in which an additional 412 patients will be enrolled.
According to both physicians, there are still tremendous opportunities to improve glaucoma treatment regimens. Dr. Kantor stated that “compliance is a huge burden to patients. … Both new medications and better drug delivery systems are critical needs.” He further opined that future glaucoma management will see the “merging of MIGS and drug delivery.”
Indeed, Glaukos has already publicly disclosed that sometime after 2020, it hopes to launch the iDose, a drug delivery device that could be implanted in the eye similar to an iStent, delivering drugs over a period of one to two years. This device could lower or even eliminate the need for patients to take topical eyedrops. Many other companies, several of which have presented at past OIS meetings, are advancing their glaucoma drug delivery projects into the clinical phase.
Both Dr. Kantor and Dr. Lewis are enthusiastic about the potential benefit of drug delivery devices, with Kantor proclaiming that “it is a big hope for the future.”
Responding to questions from Michael Weinstein, Jane Rady, divisional vice president, business development at Abbott Medical Optics (AMO), observed that there is tremendous excitement regarding MIGS and added that “AMO has been watching this space carefully.”
“We think that MIGS provides significant options for both the doctor and the patient,” and that an acquisition by AMO in this space “would enable us to leverage our strong cataract franchise.”
Rady pointed to the lucrative reimbursement rate for the cataract surgeon as one of the “key drivers” to MIGS growth and concurred with the surgeons’ view that the excellent safety profile has also been instrumental in market acceptance.