Globally, Glaucoma is on rise. According to the Glaucoma research Foundation, Glaucoma is the leading cause of irreversible blindness globally. Nearly 10% of the glaucoma patients who receive proper treatment still experience a loss of vision. Around 64.3 million people were estimated to be having glaucoma globally in 2013. Furthermore, according to the American Academy of Ophthalmology, the current prevalence is high in Africa, and Latin America. Patients who fail to respond to medications, undergo trabeculectomy surgery. However, few patients do not get completely relieved from glaucoma even after trabeculectomy surgery. Therefore, novel treatment options are required to be introduced for providing relief to such patients. Reducing intra-ocular pressure is the most important long term medical need of refractory glaucoma patients.
Refractory Glaucoma Treatment Options
The global refractory glaucoma treatment market can be characterized based on the treatment options and devices available in the market.
Ahmed Glaucoma Valve from New World Medical Inc., is a good treatment option available since 1993 for refractory glaucoma. This device also has applications in primary open angle glaucoma unresponsive to medication, neovascular glaucoma, and congenital or infantile glaucoma. Various studies have reflected the positive outcomes of using Ahmed Glaucoma Valve in refractory glaucoma both in pediatrics and adults. Therefore, this device is in very high demand and usage globally.
Alternate option like CyPass Micro-Stent from Transcend Medical showed impressive results in patients with primary open-angle glaucoma. CyPass is a micro-invasive surgery which according to the FDA guidelines needs to be performed in combination with cataract surgery. This is restricting the wider acceptance among patients due to increased cost.
Clinical trials of Xen System showed positive results with 44% reduction in eye pressure and 65% reduction in IOP medications in one year period. The Xen gel stent form Allergan reduces IOP with a permanent implant that becomes flexible, allowing doctors to use IOP reduction therapies event after the Xen implantation. Allergan received U.S. FDA approval for Xen Gel stent in November 2016. The company plans to launch the Xen Gel stent in the U.S. market, for refractory glaucoma treatment, in early 2017. The Xen system has already received CE mark and has distributed more than 10,500 stents globally. Moreover, the new surgical system is also licensed for use in Canada, Switzerland, and Turkey.
Iridex Corporation, a global provider of innovative laser systems, device and consumables in ophthalmology announced at the European Glaucoma Society held in June 2016 about the positive results of its MicroPulse P3 (MP3) device. The device powered with MicroPulse laser technology showed long term benefits for patients with refractory glaucoma. Few detailed studies with successful outcomes could lead global acceptance of this technology in future.
Glaucoma drainage devices are frequently used in refractory glaucoma to reduce the intra-ocular pressure (IOC). These devices are available in either with IOP regulating valves or without it. Ahmed glaucoma valve (AGV) is the most commonly used valve-based drainage device while Molteno, Baerveldt, Shocket, and Eagle Vision implants are the non-valved drainage devices available in the market.
Future Market Dynamics
According to the American Academy of Ophthalmology, the global prevalence of glaucoma is estimated to rise to 76 million in 2020 and 111.8 million in 2040. Rapidly aging population will be one of the important factors for the increasing prevalence rate. There would be a disproportionate rise in the prevalence in people residing in Asia and Africa. Slower adoption rate and high cost of the surgery is limiting the market growth of refractory glaucoma treatment devices in emerging nations where cataract surgery is the largely performed eye surgery. With new devices and technology being introduced, there could be a strong wave of growth experienced in the North America and European markets.
Key players in the market are focused on launching new devices to expand their product portfolio. For instance, in August 2019, New World Medical, Inc., a privately held ophthalmic company launched Ahmed ClearPath glaucoma drainage device.
In June 2019, Glaukos Corporation announced that standalone implantation of its iStent inject Trabecular Micro-Bypass System achieved substantial reduction in mean intraocular pressure in glaucoma treatment.
Key players in the market are also focused on adopting acquisition strategies to expand their product portfolio. For instance, in June 2019, Glaukos Corporation acquired DOSE Medical Corporation, a company focused on developing multiple micro-invasive, bioerodible, sustained-release drug delivery platforms for the treatment of various retinal diseases, including refractory glaucoma.