Glaucoma is the second leading cause of blindness worldwide, and the number of people with some form of glaucoma is expected to rise to 80 million by 2020, said Ike Ahmed, MD.
“This is a $6 billion market that’s continuing to grow, but our current therapies are suboptimal,” he said, adding adherence, side effects, and costs are factors limiting treatment success.
Micro-invasive glaucoma surgery (MIGS) may resolve these issues.
“By lowering the intraocular pressure (IOP) in mild-to-moderate cases, MIGS also reduces or even eliminates the need for topical medications,” Dr. Ahmed said. To date,
there are three MIGS outflow targets – Schlemm’s canal, the suprachoroidal space, and the scleral/subcojunctival space.
“This is the era of microstenting,” with companies like AqueSys, Glaukos, Ivantis, Transcend Medical, and InnFocus all major players, he said … and yet only the Glaukos iStent is approved in the US. All the devices have been granted a CE mark, and 510(k) clearance for the AqueSys Xen Gel Stent is expected by late 2016. The remaining companies haven’t yet filed for US regulatory approval.
“Big pharma” is paying attention, too: Allergan spent more than $300 million to buy AqueSys, and Alcon spent $241 million (plus milestones that may make the total investment closer to $359 million) to purchase Transcend.
While the initial MIGS market is a combined procedure with cataract removal, “the eventual market will include both MIGS/phacoemulsification and MIGS as a stand-alone procedure, the latter of which may be three to five times greater than the combined surgery,” Dr. Ahmed declared.
Globally, there are more than 5.1 million glaucoma patients on more than two medications – and these are the ideal potential MIGS patients. Once patients develop more advanced forms of glaucoma, surgeons are willing to accept more risk (i.e., trabeculectomy) to reduce pressure levels, but in ocular hypertension or mild-to-moderate forms, safety profiles of the devices become of paramount importance.
“Glaucoma is a chronic disease with high re-treatment rates, and multiple drops/interventions over the patient’s lifetime. In nearly all cases, this is a bilateral disease, and there are almost 200,000 newly diagnosed cases yearly,” Dr. Ahmed said.
MIGS devices are showing great potential, and each device has its own risk-reward paradigm.
For MIGS, Dr. Ahmed has no doubt “the future is bright.”
Ike Ahmed, MD
Dr. Ahmed is currently Assistant Professor at the University of Toronto and Professor at the University of Utah.