The Evolute Punctal Plug Delivery System provides sustained ocular drug delivery that “is as good or better than what’s out there,” said Bob Butchofsky, Mati Therapeutics Inc.’s chief executive officer. For sustained drug delivery devices to be successful, they must be easy to place and remove, must be cosmetically invisible but still easy to identify, must be tolerable, and must show consistent and sustained efficacy, he said.
In Evolute, the drug core is encapsulated in a polymer sleeve surrounded by an cyanoacrylate film. This design helps ensure “the drug only elutes into the tear film,” Butchofsky explained. In the US Phase II multicenter studies, retention was 96% in one study (n = 92) and 92% in a second study (n = 87).
The L-shaped plug is “easy to insert into the canalicular space,” he said. Patients ranked overall comfort and tearing scores as 19.3 and 19.6, respectively, on a scale of 0 to 100.
“How broad is the platform? Multiple compounds can be formulated with this system,” from prostaglandins to antihistamines and mast cell stabilizers to anti-inflammatory treatments. Dry eye treatments are an additional area, Butchofsky said.
The system has “strong intellectual property” positioning, with 82 patents already issued and another 91 pending.
Results of elution rate evaluations showed initial bursts can be “tunable” but well above the minimum target needed for delivery in models of nepafenac, difluprednate, and travoprost.
“Within the prostaglandins, travoprost may be better than latanoprost,” he said, with travoprost eluting at “much higher concentrations” than latanoprost – almost five times higher after two weeks, with travoprost producing a 7 mm Hg decrease in pressure compared with a 5 mm Hg decrease in pressure with latanoprost.
Butchofsky also noted the system’s favorable reimbursement for both physicians and optometrists.
Bob is the Founder and CEO of Mati Therapeutics Inc. Mati is developing a non-invasive sustained drug delivery platform focusing on anti-inflammatory compounds – both a steroid and non-steroidal, and glaucoma.