Mati Therapeutics

Mati is developing a punctal plug drug delivery technology for sustained drug delivery using an “L-shaped” design to deliver medications to the canalicular space. Insertion is via slit lamp, with only the initial procedure requiring patient dilation. The company’s device separates itself from others in that there is a one-directional drug flow out of the plug. There is a solid polymer matrix core, an adhesive on one end, and the traditional silicone used in the punctal plug itself. The drug eludes solely onto the surface (directly into the tear film), reducing overall systemic absorption rates.

The device has been evaluated in more than 150 patients. The GLAU12 study had a 12-week duration with a 96% retention rate; GLAU13 showed a 92% retention rate. An eight-week extension study showed a 97% retention rate.

Mati’s lead program is evaluating latanoprost in its punctal plug system for the treatment of glaucoma. There’s an ongoing Phase IIb study. The company is also evaluating allergy medication olopatadine in a Phase II study and a non-steroidal that will begin Phase II in 2016. The firm also plans to evaluate steroids.

Previously discussed GLAU12 results showed a consistent 5- to 6-mm Hg decrease. The side-effect profile was acceptable. In 421 patients inserted with the current (95 mg) or previous iteration, the most frequently reported adverse event is increase in tearing, at about 13%. Tearing is mild in nature and usually resolves within the first week or so of treatment. Rates of conjunctival hyperemia were 7.5%, or about half of what is reported in the latanoprost package insert.

The company is also evaluating the plug with travoprost and boosting the drug load through higher elution rates. Canine models indicated the maximum intraocular pressure (IOP) difference was in the 7- to 8-mm Hg range, and the firm expects to move this formulation into human Phase II trials next year.

In the non-steroidal program, Mati has targeted an initial drug elution rate of 3 mg/day during the immediate post-surgical period and move to a quick diminishment of a steady-state level throughout the remainder of the post-surgical period.

Intellectual property remains one of the company’s strengths; on average Mati is adding a new patent every 2.5 weeks. Currently, the company boasts 62 issued patents and an additional 106 pending.

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