By Larry Haimovitch
Medical Device Daily Contributing Writer

CHICAGO—Long a stepchild in the ophthalmology world, glaucoma has recently emerged as a lucrative sector for technology and market growth. Glaucoma’s new stature was on display here last week at the San Francisco-based American Academy of Ophthalmology (AAO) annual meeting. The AAO is by far the largest annual ophthalmic meeting with approximately 30,000 attendees.

The paradigm shift for treating this symptomless disease, which is the second leading cause of blindness in the world, has been led by San Clemente, California-based Glaukos. Its minimally invasive glaucoma surgical (MIGS) device, tradenamed the iStent, has been extremely well received, benefitting from an excellent safety profile, a very favorable reimbursement scenario and deft sales and marketing strategies. Revenue for the iStent has soared since FDA approval in mid-2012 and is projected to reach about $110 million in 2016. This stellar performance is one of the strongest ever in the medical device arena. MDD estimates that U.S surgeons will implant approximately 100,000 iStents this year.

The entire MIGS market appears poised for explosive growth. According to Bill Freeman, a venerable ophthalmic industry consultant from St. Louis, Missouri-based Market Scope, the MIGS market could reach $900 million (900,000 units) by 2021, up dramatically from $100 million (110,000 units) this year.

The iStent has not faced any domestic competition to date. However, a major new competitor is looming with the introduction in the U.S. of the Basel Switzerland-based Alcon/Novartis Cypass device. In February, Alcon entered the MIGS fray when it acquired privately-owned Menlo Park, California-based Transcend Medical for about $240 million, plus future milestone payments which could bring the total deal to well over $500 million. The first milestone payment of $75 million was earned in late-July when the FDA approved CyPass. Alcon has already hired a sales force of approximately 25 reps and has just begun a controlled rollout. A full-blown launch will commence in early 2017.

One of the hottest topics at the AAO was which MIGS device is the best and what impact Alcon, a sales and marketing juggernaut with huge resources, will have on Glaukos’s growth and the overall MIGS market.

At an Ophthalmology Innovation Summit sponsored pre-AAO meeting, the moderator Dr. Rick Lewis, a comprehensive ophthalmologist at Sacramento California-based Sacramento Eye Consultants kicked off the meeting with the comment that “MIGS is now an accepted part of what  ophthalmic surgeons now regularly do. This was definitely not the case just a couple of years ago.” Renowned veteran ophthalmic surgeon Richard Lindstrom from Minnesota Eye Consultants in Minneapolis heartily supported Lewis’s view, noting that it is a huge benefit to his many non-compliant glaucoma patients.

At a Glaukos-sponsored analyst meeting here, Dr. John Berdahl a glaucoma specialist from Sioux Falls, South Dakota-based Vance Thompson Vision and Dr. John Hovanesian a comprehensive ophthalmologist from Laguna Hills, California-based Harvard Eye Associates strongly endorsed MIGS in general and the iStent in particular. Berdahl described MIGS as his “go to procedure which fills a huge gap between eyedrops and surgery” while Hovanesian called it a “why not” procedure. Both believe that the MIGS market is vastly underpenetrated and will show huge growth in the next few years.

All four surgeons are very enthused about MIGS technology that is in the pipeline. These include the Cypass, the iStent Supra, the iStent Inject, the iDose and the XEN. Not discussed and in the later stages of FDA trials are  the Hydrus stent from Irvine, California-based Ivantis Inc. and the Microshunt from Miami-based InnFocus Inc. These devices are projected to enter the U.S. market in the 2018-2019 timeframe.

InnFocus was acquired by Osaka, Japan-based Santen Pharmaceutical Ltd. earlier this year for about $225 million and several possible future milestone payments. Privately-owned Ivantis is now one of two  independent MIGS companies (publicly-traded Glaukos is the other) and most industry pundits expect that one or both will be ultimately acquired. Ivantis has completed enrollment of the largest MIGS trial ever and Its clinical data will be released in about one year.

The Cypass and the iStent Supra are placed in the suprachoroidal space, whereas the iStent is implanted in the trabecular meshwork. Some surgeons favor the suprachoroidal location, because it is easier to implant while the trabecular meshwork camp favors it because of its perceived better safety. Their clinical efficacy, which is hotly debated by each side, appears to be quite similar.

The iStent Supra, which will compete head-to-head against CyPass, is expected to complete its pivotal trial enrollment in the next few months. A two year FDA-mandated follow-up means implies that it will most likely reach the U.S. market in 2019.

The iStent Inject, which embodies two stents implanted in one simple procedure, will complete its two year FDA-mandated follow-up in July 2017. FDA approval is likely in the first half of 2018. Reports from outside the U.S. where it is actively being sold are very positive, with ease of use and better reduction of intraocular pressure cited as the main reasons for their strong acceptance.

The iDose addresses the Achilles heel of all glaucoma drugs, the troublesome  lack of compliance. A plethora of studies have shown that less than 50% of galucoma patients are compliant with their drug regimens. Employing a drug delivery glaucoma device that could be implanted in the eye similar to an iStent, iDose may potentially deliver glaucoma drugs over a period of one or two years.

There are myriad companies working in the drug delivery arena but most use a polymer to control drug elution over time, which limits the amount of drug that can be stored and ultimately delivered to the eye. The iDose product uses a depository to hold the drug and has configured to maximize the amount of drug in the depository. Enrollment for the iDose clinical trial recently began and it is not likely to reach the U.S. market until 2020 or 2021.

There were several comments regarding the Xen stent, which Dublin-based Allergan, plc gained access to when acquired Aliso Viejo, California-based Aquesys, Inc. about a year for $300 million plus milestone payments.  This device, which is implanted in the subconjuctiva, is expected to gain FDA approval soon. Lindstrom believes that this stent will be more readily adopted by glaucoma surgeons than cataract specialists “because it is more challenging to implant and requires the use of mitomycin-C”.

In a different approach of glaucoma therapy, Mountain View, California based Iridex Corp. is enjoying robust growth with its laser-based, tissue-sparing micropulse therapy. This procedure is performed on its Cyclo G6 system, which includes a dedicated laser along with a family of single use probes. Since its introduction in early 2015, Iridex has shipped over 400 Cyclo G6 lasers worldwide.

Several presentations at the packed Iridex booth addressed the pressing need for new approaches to treat glaucoma, with current treatment options typically lacking both either safety or efficacy. Presenting surgeons stated that this technology offers an “ideal solution” for the management of this chronic disease for several reasons--it is easy to learn, is efficient, repeatable and leaves future treatment options open.

Rolando Toyos, MD from the Memphis, Tennessee based Toyos Clinic. gave a talk titled “Cyclo G6—An Alternative to Stents for Glaucoma,” He discussed his excellent results with the Cyclo G6, noting that the lion’s share of his patients have experienced a 30% to 45% reduction in intraocular pressure and a 50% to 60% decrease in the need for glaucoma drops.

Dr. Toyos indicated that in his area of the country there is an acute shortage of glaucoma specialists. Coupled with very poor medication compliance he lamented that “we have been losing the war against vision loss.” He strongly endorsed the Iridex laser and tells his patients that this is a “more gentle, softer” treatment option. He also positioned micropulse laser therapy as an alternative to a MIGS procedure.

In the refractive surgery space, three companies with corneal inlay devices have been generating positive publicity of late. These tiny implants, which are placed in the cornea, are designed to treat presbyopia for middle-aged people. The potential market opportunity is enormous. 

Irvine, California based, privately-owned Acufocus was the first to gain FDA approval although sales of its Kamra inlay have been mediocre since the approval in April 2015. This lens is a non-powered implant placed in the non-dominant eye, utilizing the “pinhole effect” to focus light and thus enhance a patient’s near vision.

The company received a massive vote of confidence in September when legendary private equity firm, New York City-based Kohlberg, Kravis & Roberts & Co. L.P. invested $66 million. This will enable Acufocus to boost its Kamra sales and marketing efforts and to also accelerate the clinical development of its IC-8 extended depth of focus intraocular lens.

The IC-8 has already achieved a CE Mark and superb results were reported at the recent Dublin based-European Society of Cataract and Refractive Surgery meeting. According to informed industry sources, Acufocus has commenced a domestic IC-8 clinical but is at least two years or more away from FDA approval.

Irvine, California based ReVision Optics is the second entrant in the U.S. following a late-June FDA approval for its Raindrop inlay. Made of a non-powered hydrogel material, it is placed under a LASIK-like flap in the non-dominant eye to “bulk” up the cornea and change the patient’s vision. The company, which is venture capital-backed, has recently hired its first sales reps and is slowly rolling out the product in the U.S. Its booth at the AAO was very active and attractively configured.

Dublin-based, publicly-traded Presbia plc, also competes in the corneal inlay market with its Flexivue Microlens. This implant features a powered lens, just like reading glasses. It is adjustable with age, with the original lens removed and replaced with a higher powered lens.

The company completed its pivotal trial enrollment in July 2015 is now in its FDA-mandated two-year follow-up. Final FDA approval appears likely in the first half of 2018. Interim six month follow-up results from this trial, released earlier this year, showed good safety and efficacy for the device.

2016 American Academy of Ophthalmology

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