WASHINGTON, DC – When Stanford University ophthalmology professor Kuldev Singh, MD, MPH, underwent medical training 25 years ago, there were maybe five to six non-pharmaceutical treatment options to manage glaucoma. Today, there are some 17 different approaches, he said during a session on microincisional glaucoma surgery (MIGS) at the OIS@ASCRS meeting, and more are on the way.
The ophthalmic market has a predicted annual growth rate of 6% through 2023, according to Marketscope data, while glaucoma surgery is outpacing all other avenues, at 27.5% growth over the next five years. “Clearly driving this growth is the microincisional or minimally invasive/MIGS category,” Dr. Singh said.
‘No Free Lunch’
In recent years, glaucoma specialists have taken advantage of numerous, novel surgical technologies, Dr. Singh said. Some of the implantable devices have had very large clinical trials necessary for Food and Drug Administration approval and thus have been extremely well studied in terms of efficacy and safety.
“We have many excellent glaucoma surgical choices covering the entire treatment spectrum but with glaucoma surgery there’s no free lunch,” Dr. Singh said. “There’s generally a trade-off between efficacy and safety. So if you go to more effective procedures in terms of intraocular pressure [IOP] lowering, the price is greater in terms of postoperative side effects.” There is great anticipation regarding two devices that may gain FDA approval in the near future: the Hydrus Microstent (Ivantis) and the G-2 version of the iStent (Glaukos).
For patients with more advanced disease, trabeculectomy and long tube implantation may not go away completely but there are likely to be some challengers. Dr. Singh noted particular excitement surrounding Santen’s MicroShunt. “This is probably the most widely anticipated device for the glaucoma specialist who deals with moderate to advanced glaucoma patients,” he said. The device, created of a polystyrene-block-isobutylene-block-styrene biocompatible material, is placed into the anterior chamber under a conjunctival flap.
It is being studied head to head in a randomized, controlled trial against trabeculectomy. “I think of all the devices out there for refractory glaucoma, this is the one that’s probably most likely to compete with trabeculectomy going forward, but I don’t see trabeculectomy going away completely as no other procedure can predictably get IOPs into single digits when necessary,” Sr. Singh said.
Volume Validates the Space
The large number of innovative products in this space “validates the entire segment and opportunities for all companies involved,” said Jane Rady, senior vice president of corporate strategy and business development for Glaukos, during a panel discussion. “Historically, we had to select patients for the treatments that were out there. Now we have enough treatments out there that we can select the right treatments for the patients.”
Experts wondered if they could ever get to an efficacious approach to dealing with glaucoma “without doing some really tough things to the eye,” said Michael Onuscheck, president and general manager of the global surgical franchise of Alcon. “We’re quite excited about what happens to the patient and how responsive they are to these [minimally invasive] approaches,” he said, but acknowledged a need for further exploration for pseudophakic patients and for those with refractory glaucoma.
As patients live longer, “the attentiveness and level of invasiveness one has to apply to preserve vision is going to go up,” added Jonathan Talamo, MD, chief medical officer and vice president of medical and clinical affairs for Johnson & Johnson Vision. He referenced a statistic from Europe that nearly half of glaucoma patients are blind in one eye by the time they die. “We have a long distance to go before we get to the bar that as clinicians we want to be at in caring for the glaucoma population,” he said.
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