This patent, which will not expire until 2027, relates to a drug delivery system for administering an ophthalmic drug through a hydrogel lacrimal implant into one or both puncta (tear ducts) of the eye.
With the issuance of this patent, Mati is now the only company with exclusive rights to commercially make, use, import or sell this proprietary hydrogel ophthalmic drug delivery system in the United States.
This newly issued patent further enhances Mati's patent portfolio, which includes 19 different patent families and scores of patents and patent applications filed in the US and other major international markets.
The portfolio protects important elements of Mati's Evolute punctal plug delivery system for treatment of ocular indications.
Mati said the Evolute platform includes features for retaining the punctal plug within the nasolacrimal system of the eye during drug elution and sustained release formulations currently in development for the treatment of post-operative pain and inflammation.
The proprietary technology has the potential to be used for multiple disease states with consistent, sustained efficacy.
Mati Therapeutics is developing the Evolute sustained ocular drug delivery platform, which Mati believes has the potential to treat a range of ocular indications.
The platform utilises a device called a punctal plug, which is easily inserted into a patient's punctum. The device has already been approved to treat dry eye syndrome, but Mati is the first to conduct clinical trials in the US 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.
The company has completed multiple Phase II clinical trials using the Evolute platform and recently announced interim results from a Phase II study of nepafenac versus placebo in patients undergoing cataract surgery. Pain scores favored nepafenac over placebo at Day 1, Day 3, and Day 7, following surgery.
At Day 3, 71% of patients treated with nepafenac experienced No Pain versus 12% in the placebo arm. The company expects to initiate a Phase III study with nepafenac in 2019.
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