Three-year stand-alone data (not combined with cataract surgery) shows minimally invasive, non-implantable glaucoma surgery effectively reduces intraocular pressure and reduces the need for IOP-lowering drugs in patients with open-angle glaucoma
MENLO PARK, Calif., Aug. 16, 2022 (GLOBE NEWSWIRE) — Vision Sciences, Inc. (Nasdaq: SGHT), an eye care technology company focused on developing and commercializing innovative solutions to transform care and improve the lives of patients, today announced post-operative follow-up results from 36 OMNI month® Surgical system. The data demonstrates that the OMNI Surgical System provides safe, consistent, and durable results in adult patients with open-angle glaucoma (OAG) on a stand-alone basis.
The study showed that canaloplasty followed by trabeculotomy using the OMNI® Surgical System achieved a mean intraocular pressure (IOP) reduction of at least 20% for all 26 patients (38 eyes) at 36 months of follow-up. At 12, 24, and 36 months after surgery, patients’ mean preoperative IOP after drug withdrawal decreased from 24.6 ± 3.2 mmHg to 14.5 ± 1.7 mmHg, 14.2 ± 2.0 mmHg and 15.0 ± 1.9, respectively. The mean number of IOP-lowering drugs was reduced from 1.9 ± 0.7 to 0.4 ± 0.6, 0.6 ± 0.7 and 0.5 ± 0.7 at 12, 24 and 36 months . Postoperative IOP and reduction in medication use at 12 months remained constant over three years, suggesting robust and long-lasting efficacy of the OMNI Surgical System when used as a stand-alone intervention in phakic or pseudophakic eyes. Only a minimal number of adverse events were reported, all of which resolved without any intervention except for one eye which required secondary IOP reduction intervention.
“As we continue to evaluate this group of patients with the OMNI Surgical System, the results consistently show that the minimally invasive procedure has the potential to provide long-term benefits to patients with open-angle glaucoma,” Karsten said. Klabe, MD, Principal Investigator, Chief Surgeon of Breyer, Kaymak & Klabe Augenchirurgie. “Most patients experienced an IOP reduction of at least 20% and required significantly less medication, which is the goal of the study. By effectively reducing IOP and medication burden , the OMNI Surgical System transforms the way glaucoma is managed in both patients with combined cataract and autonomic glaucoma.
The clinical observation included 38 eyes of 26 OAG patients treated with the OMNI Surgical System. Follow-up visits were performed on day 1, week 1, and months 1, 3, 6, 12, 18, 24, 30, and 36 after surgery. This test is an extension of 24 month data published in Clinical Ophthalmology in June 2021.
“The OMNI Surgical System is supported by a robust clinical development program, which includes this three-year treatment evaluation in patients with open-angle glaucoma. These results highlight the long-term efficacy and strong safety profile of the OMNI Surgical System. This non-implantable procedure has been shown to be effective without the known IOP-lowering aid of cataract surgery. We look forward to ongoing data collection and sustainability assessment at additional intervals after micro-invasive root canal surgery with OMNI,” said Paul Badawi, co-founder and CEO of Sight Sciences.
Data results were presented in June at the 15e Congress of the European Glaucoma Society (EGS) in Athens, Greece.
About vision science
Sight Sciences is an eye care technology company focused on developing and commercializing innovative solutions to transform care and improve the lives of patients. By using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that improve patient care and supplant outdated conventional approaches. The OMNI of society® The surgical system is a minimally invasive glaucoma surgery (MIGS) device indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG), the world’s leading cause of irreversible blindness. Company TearCare® The system is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye due to Meibomian Gland Dysfunction (MGD), allowing physicians to eliminate office blockages of the glands to treat the primary cause of dry eye.
For more information, visit www.sightsciences.com.
About OMNI® Surgical system
THE OMNI® Surgical System is a portable, single-use therapy device for minimally invasive glaucoma surgery (MIGS). It is indicated for canaloplasty (the microcatheterization and viscodilation of Schlemm’s canal) followed by trabeculotomy (the cutting of the trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Through a single clear corneal microincision, OMNI® allows surgeons to access 360 degrees of Schlemm’s canal and address all three sources of flow resistance in the eye’s diseased conventional outflow pathway (trabecular, Schlemm’s canal and collecting ducts).
OMNI® is indicated by the FDA for canaloplasty (the microcatheterization and viscodilation of Schlemm’s canal) followed by trabeculotomy (the cutting of the trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma. OMNI is CE marked for catheterization and transluminal viscodilation of Schlemm’s canal and cutting of the trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.
OMNI® should not be used in situations where the iridocorneal angle is compromised or has been damaged as it may be impossible to visualize the angle or pass the microcatheter properly. Do not use the OMNI® in patients with angular recession; neovascular glaucoma; chronic angle closure; angle-closure glaucoma; traumatic or malignant glaucoma; or narrow entry channels with plateau or quadrant irises with anterior MIGS implants.
OMNI® received its first FDA clearance in 2017 and is protected by a global patent portfolio comprising 32 issued patents worldwide.
OMNI® is a registered trademark of Sight Sciences.
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