Sight Sciences is aiming to lead the charge of the stand-alone Minimally Invasive Glaucoma Surgery (MIGS) and has the data to prove it. A study, showing two-year outcomes of the Menlo Park, CA-based company’s Omni Surgical System, was published in Clinical Ophthalmology.
The data show the safety, efficacy, and durability of the effect of the Omni for use in standalone procedures to reduce in intraocular pressure and medication burden.
Most MIGS devices have been approved to be conducted in connection with cataract surgery.
“By comprehensively addressing the entire conventional outflow pathway circumferentially with Omni, clinicians can address outflow resistance wherever it occurs,” said Dr. Klabe. “Omni offers clinicians a safe, effective and minimally invasive option for treating both phakic and pseudophakic patients outside of cataract surgery. I’m excited to see these outcomes further validate my clinical experience and success using Omni on a stand-alone basis.”
Data from the study, conducted and co-authored by Karsten Klabe, M.D. and Hakan Kaymak, M.D., show that use of OMNI to perform a standalone MIGS in mild to moderate open-angle glaucoma resulted in statistically significant reductions in both IOP and IOP-lowering medication use at 24 months. The study included long-term (24-month) outcomes from 38 eyes of 27 subjects with open-angle glaucoma.
Mean baseline IOP in the study decreased from 24.6 mmHg preoperatively to 14.7 and 14.9 mmHg at months 12 and 24, respectively, reductions of approximately 10 mmHg or approximately 40%. All subjects in the study, and 100% of eyes, had at least a 20% IOP reduction at 24 months.
Mean baseline IOP-lowering medication also decreased from 1.9 average medications per patient to 0.5 medications at month 24. At 24 months, nearly 60% of eyes were free of IOP-lowering medication. Both IOP and IOP-lowering medication reduction outcomes in the study were statistically significant (p<.0001). Importantly, the study cohort included primary open-angle glaucoma (71%) and pseudoexfoliation glaucoma (29%) patients, as well as phakic (74%) and pseudophakic (eye with an intraocular lens; 26%) eyes.
Sight Science’s CEO Paul Badawi said the standalone MIGS market is massive, according to a Seeking Alpha transcript of the firm’s most recent earnings call.
“We believe the U.S. standalone mix segment is approximately five times larger than the $1 billion U.S. combination cataract segment and is substantially undeveloped,” said Badawi, according to a Seeking Alpha transcript of the earnings call.
The company said the Omni surgical system is cleared by FDA and CE-Marked for canaloplasty followed by trabeculotomy to reduce IOP in adult patients with primary open-angle glaucoma (FDA) and open-angle glaucoma (CE). Sight Sciences intends to further develop Omni, and to seek regulatory clearance, for expanded indications.
All Eyes on the MIGS market
Right now, the MIGS market is estimated to reach about $786 million by 2026 at a CAGR of 23%, according to report from MarketWatch. San Clemente, CA-based Glaukos is arguably one of the biggest players in the space. The company is a pioneer in MIGS - having won a nod for its iStent in 2012.
“We pioneered the MIGS market and are going to fight hard for it, but our ambitions go well beyond this category,” Thomas Burns, president and CEO of Glaukos said, according to a transcript of an earnings call from The Motely Fool. “The funding from our U.S. combo cataract iStent franchise has enabled us to build a pipeline with a breadth of magnitude that may be unmatched in this industry.”
The company announced a bold vision of transitioning into a hybrid surgical, pharmaceutical, and medical device firm in 2019, during a presentation at the J.P. Morgan Healthcare Conference.