KDB GLIDE® Receives FDA 510(k) Clearance for Expanded Indication in Glaucoma Treatment

New World Medical announced a significant milestone with the receipt of 510(k) indication expansion from the U.S. Food and Drug Administration (FDA) for KDB (Kahook Dual Blade) GLIDE.

This clearance allows for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG) during cataract surgery or as a standalone procedure, making KDB GLIDE^® the only goniotomy device with this indication.

FDA's Validation of KDB GLIDE^®

FDA's decision, based on robust data validating the safety and efficacy of KDB GLIDE^®, underscores the device's reliability in reducing IOP in POAG patients. Backed by over 100 published studies, including Level-I randomized controlled trial (RCT) data and 5-year published data, KDB GLIDE has demonstrated an average IOP reduction of ≥20%.

Raymond Kong, Chief Commercial Officer at New World Medical, remarked on the significance of this clearance, stating, "This expanded clearance from the FDA acknowledges and validates the patient outcomes that ophthalmic surgeons have been seeing since the launch of this product. With recent increased scrutiny around reimbursement for minimally invasive glaucoma surgery (MIGS) procedures, this validation from the FDA is a significant step for New World Medical, the ophthalmology space, and most importantly the patients who benefit from our products."

The Role of Goniotomy in Glaucoma Treatment

Described by the American Academy of Ophthalmology as a well-established MIGS procedure, goniotomy involves the incision or excision of trabecular meshwork tissue (TM) to reduce IOP. The excision of TM tissue allows for improved aqueous flow, thus reducing IOP. The KDB GLIDE, designed as a revolutionary surgical tool for precise excision of TM tissue during goniotomy procedures, offers surgeons enhanced procedural flexibility and efficacy.

The expanded indication of KDB GLIDE^® further validates the effectiveness and reliability of the Kahook Dual Blade in excisional goniotomy procedures.

Dr. Malik Y. Kahook, inventor of KDB and Chief Medical Advisor at New World Medical, highlighted the significance of this achievement, stating, "We have been focused from day one on making KDB one of the most studied surgical devices in the field of glaucoma. Our extensive peer-reviewed publications, including Level I RCT data, have resulted in the momentous occasion of expanding the label of KDB GLIDE. Treating glaucoma through excisional goniotomy with KDB has now entered a new era, and I feel like we are just getting started."