Completion of Facility Enables Initiation of Phase 3 Clinical Trial of Nepafenac in Patients Undergoing Cataract Surgery
AUSTIN, Texas, Sept. 12, 2023 /PRNewswire/ — Mati Therapeutics Inc. (“Mati”) announced that it has completed and now occupies a facility dedicated to manufacturing all products formulated in Mati’s proprietary Evolute® sustained ocular drug delivery platform. The 10,000 square foot facility is located in Bryan, Texas and has the capacity to fulfill all manufacturing needs for both development and commercial purposes for the foreseeable future. Mati engineers designed, built, and programmed each of the robotic devices used in a multi-step process to manufacture each product in the Evolute® platform.
“Following pandemic-related disruptions to global supply chains, we determined it was both time and cost effective to directly control the manufacturing process for all of the product candidates in our pipeline,” said Bob Butchofsky, CEO of Mati. “Following completion and occupancy of this facility, we are now in position to initiate a Phase 3 trial of nepafenac to treat post-operative pain in patients undergoing cataract surgery. We expect to begin this trial in the coming weeks. Our ability to control our manufacturing schedule will reduce potential delays from ongoing supply chain interruptions, provide more flexibility in our development efforts, and will greatly reduce our commercial cost of goods sold.”
About Mati Therapeutics Inc.
Mati is developing the Evolute® sustained ocular drug delivery platform, which Mati believes has the potential to treat a range of ocular indications. The platform utilizes a device called a punctal plug, which is easily inserted into a patient’s punctum, or tear duct. The device has already been approved to treat dry eye syndrome, but Mati is the first company to conduct clinical trials in the U.S. using punctal plugs as an anchoring device for a drug delivery platform. A drug-eluting core is inserted into Mati’s proprietary punctal plug, which allows medication to be continuously released into the tear film of the eye over a period of time. Mati believes the Evolute® platform has the potential to become a more reliable alternative to several eye drop therapies, which can be ineffective because many patients are unwilling or unable to adhere to self-administered eye-drop regimens.
Mati has two candidates ready to enter Phase III pivotal trials including nepafenac for post-operative pain and dexamethasone for post-operative inflammation, both following cataract surgery. Additionally, Mati is developing travoprost, which is in Phase II trials for the treatment of glaucoma and ocular hypertension. Mati’s proprietary punctal plug design has demonstrated excellent lower punctum retention rates of 92% and 96% over a 12-week follow-up period in two separate multi-center U.S. clinical trials.
To learn more about Mati Therapeutics, visit www.MatiTherapeutics.com.
Contact: Bob Butchofsky, CEO
Mati Therapeutics Inc.
+1 512 720-1333
SOURCE Mati Therapeutics