Glaukos Corporation Announces Australia’s TGA Regulatory Approval for PRESERFLO™ MicroShunt
June 08, 2021 at 07:00 am EDT
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Glaukos Corporation announced that the Therapeutic Goods Administration (TGA) of Australia has granted regulatory approval for the PRESERFLO MicroShunt intended for the reduction of intraocular pressure (IOP) in eyes of patients with primary open-angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. The PRESERFLO MicroShunt is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with primary open-angle glaucoma whose IOP is not controlled when using maximum tolerated glaucoma medications or where glaucoma progression warrants surgery. IOP reduction is the most effective means of preventing the progression of glaucoma and vision loss. Made of a proprietary, biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)], the PRESERFLO MicroShunt is a flexible, 8.5-mm-long tube with planar fins to help fixate the device in the tissue through a micro-incision and prevent leakage and migration. Glaukos plans to commence initial commercial launch activities for the MicroShunt in Australia in late 2021, with a full commercial launch targeted in mid-2022 following the establishment of formal reimbursement. Under its current development and commercialization license agreement with Santen Pharmaceutical Co. Ltd. (Santen), Glaukos has exclusive commercialization and development rights for the MicroShunt in Australia. In addition, Glaukos also has exclusive commercialization rights and control of all development activities, including over clinical development and regulatory affairs activities, for the MicroShunt in the United States, Canada, New Zealand, Mexico, Brazil and the remainder of Latin America.
Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company. It develops novel, dropless therapies and commercializing associated products for the treatment of glaucoma, corneal disorders and retinal disease. Its product candidates include Micro-Invasive Glaucoma Surgery products that involve the insertion of a micro-scale device designed to reduce intraocular pressure (IOP) by restoring the natural aqueous humor outflow pathways for patients suffering from glaucoma and procedural pharmaceuticals based on an intracameral drug delivery technology designed to reduce IOP by delivering therapeutic levels of glaucoma medication from inside the eye over an extended period of time. Its products include transdermal pharmaceuticals that are applied to the eyelid and designed to treat glaucoma, dry eye, presbyopia and other ocular surface diseases and disorders and micro-invasive, bio-erodible sustained release drug delivery implants to improve the vision of patients.