Non-invasive punctal plug delivery system offers a host of positive performance characteristics
System delivers predetermined drug dosage directly to tear film, improving retention rates
In contrast to other platforms being developed for sustained topical ophthalmic drug delivery, this system is distinguished as the only one that delivers all of its medication to the tear film, does so at a constant rate, and is cosmetically invisible yet easily identifiable.
“Patient acceptance is important for adoption of these systems, and aesthetics as well as comfort are important attributes for patients,” Muller said.
A non-bioerodable delivery system was developed because it could incorporate all therapeutics and assure predictable medication release, said Robert Butchofsky, chief executive officer and founder, Mati Therapeutics.
“Our system can be used to deliver any medication whether it is hydrophobic or hydrophilic, and the matrix of the drug-containing core can be tailored to the specific therapeutic to deliver a desired rate of release and duration,” he said. “For example, we can create a flat elution curve for a constant delivery rate desirable for more chronic conditions, or it can be adjusted to deliver an initial burst with higher doses and subsequent downward titration often needed for more acute conditions.”
Since the plug does not dissolve and maintains its physical configuration while in the punctum, it eliminates the potential for interindividual variability which can affect the release profile and retention rates, he added.
In the studies completed using the plug, the retention rate has been consistently high, between 92% and 96%, Muller reported.
“The high retention rate is an important advantage of our system,” Muller said. “Retention becomes a problem using plugs that erode, and retention rates for standard punctal pugs are generally in the 50% to 60% range. We invested a lot of time and effort into designing our platform to ensure a high retention rate, and the available data show that we were successful.”
Easy insertion is another benefit of the delivery system. The plug has an L-shaped design which facilitates its placement while improving retention. The placement procedure has a minimal learning curve and is completed in one to two minutes.
“After verifying that the plug is oriented in the proper direction, it can be slipped easily into the nasolacrimal duct, just like a piece into a puzzle,” Muller said.
Although the device is cosmetically invisible, it is colored and readily seen when the lower lid is retracted. Therefore, it is easy for the physician to identify the plug when it is time for it to be removed and also for the physician, patient, or caregiver to confirm that the plug is still in place during the treatment period.