The first glaucoma patient has been enrolled in Nova Eye Medical’s MulticentreAb-interno Glaucoma study Investigating Canaloplasty (‘MAGIC’) Trial.
According to the World Health Organisation, glaucoma is the world’s second leading cause of blindness, with the number of suspected cases of glaucoma estimated at over 60 million worldwide.
The first MAGIC patient was enrolled at the Eye Physicians & Surgeons of Arizona, in the United States, by principal investigator Shamil Patel, MD.
According to Dr Patel, the unique mechanism of ab-interno canaloplasty, which reduces outflow resistance in all parts of the natural drainage system, has a critical role in the glaucoma treatment armamentarium. Further, the ability to deploy abinterno canaloplasty as a standalone procedure, and in combination with cataract surgery, supports its versatility in the glaucoma treatment algorithm.
“Ab-interno canaloplasty is akin to cardiac angioplasty for the eye. It employs a multimodal mechanism to address multiple points of blockage in the natural drainage system. Since first adopting the procedure in 2013, it has proven to be a highly effective treatment for the majority of my mild-to-moderate open-angle glaucoma patients. Most patients achieve post-operative pressures in the low teens following ab-interno canaloplasty,” said Dr Patel.
The MAGIC Trial will be performed over 12 months and will enrol up to 160 patients with mild-to-moderate, uncontrolled primary open-angle glaucoma (POAG) on one to four medications. Patients will be randomised to treatment with either the iTrack canaloplasty microcatheter or the OMNI surgical system (Sight Sciences).
Ab-interno canaloplasty will be performed as a standalone procedure during the trial to eliminate the confounding effect of cataract surgery. Primary endpoints will include reduction in mean intraocular pressure (IOP) and mean number of antiglaucoma medications. Secondary endpoints will include surgical and post-operative complications.
In the MAGIC Trial, the impact of OVD volume in relation to clinical efficacy will be assessed
Introduced in 2008, Nova Eye Medical’s proprietary iTrack canaloplasty microcatheter is the world’s first canaloplasty device. Further, it is the only device that enables the surgeon to customise the volume of ophthalmic viscosurgical device (OVD) – a hyaluronic acid-based gel-like substance – delivered during the ab-interno canaloplasty procedure in order to best meet the needs of each individual patient. In the MAGIC Trial, the impact of OVD volume in relation to clinical efficacy will be assessed.
According to lab testing conducted by the Company, the iTrack canaloplasty microcatheter delivers more OVD into Schlemm’s canal than any other canaloplasty device. It also delivers OVD via a pressurised mechanism, designed to pop open herniations of the collector channels.
“With iTrack I take advantage of the capability to titrate the amount of OVD delivered based on the patency of Schlemm’s canal. For example, I will deliver more OVD in cases where the canal is very occluded, in order to effectively break adhesions and push out herniations of the trabecular meshwork,” said Dr Patel.
A tissue-sparing, implant-free procedure with the added benefit of a simplified postoperative regimen, iTrack is routinely deployed by surgeons as an earlier stage intervention in the treatment of mild-moderate glaucoma patients.
“The pathogenesis of glaucoma is different in every patient. The challenge for surgeons is to assess which MIGS are best suited to their various patient populations. We are seeing an increasing number of surgeons turn to iTrack to clear obstructions throughout the natural drainage system and to re-open collector channels, before resorting to tearing tissue or moving beyond the natural drainage system to the subconjunctival space,” commented Mr Bankovich, President of Nova Eye Medical.
“Tissue-sparing, ab-interno canaloplasty is well suited to earlier in the disease process, prior to MIGS procedures which remove or tear tissue. Glaucoma is a multifactorial disease and will invariably progress in most patients. Further, due to increasing life expectancy, patients have a higher lifetime risk for glaucoma development and generally live longer when they do have glaucoma. By preserving tissue early in the disease process, iTrack reserves the option for future glaucoma treatments.”
The MAGIC Trial is expected to reinforce the clinical utility of ab-interno canaloplasty in the treatment of mild-moderate glaucoma patients. Nova Eye Medical anticipates publication of the completed 12-month results in the second half of 2022.