A silicone punctal plug-based system for sustained delivery of ophthalmic medications (Evolute, Mati Therapeutics) is versatile technology which can be implemented across multiple therapeutic categories and shows promise for improving efficacy and safety relative to conventional topical drop therapy.
The non-invasive sustained delivery platform is comprised of a non-biodegradable/non-bioerodable punctal plug with a drug-eluting core that is sealed along the sides and at the distal end. Drug delivery occurs only to the tear film and at a predictably precise rate for a predetermined duration. Therefore, the system avoids under- or overdosing.
In addition, because drug is not released into the nasolacrimal duct, the punctal plug system minimizes the potential for systemic absorption and related adverse events. The device has an ocular safety advantage as well because the drug load is in a solid state which obviates the need for any preservative.
Clinical development of the technology was initiated using latanoprost. Results from testing completed through multiple phase II trials in 179 patients showed the modality was effective in providing IOP-lowering. In addition, device retention, tolerability, comfort, and patient acceptance were excellent.
The company is finalizing plans to launch a phase II trial of a sustained-release travoprost punctal plug. In addition, phase II trials investigating systems for delivery of three other candidate medications--nepafenac, difluprednate, and olopatadine--may also begin in 2017.
“This technology is being developed as a long needed replacement for topical drops due to its ability to deliver greatly increased compliance, a reduction in potential systemic side effects, and desirable patient convenience,” said Christopher A. Muller, chief commercial officer and co-founder, Mati Therapeutics.
The company is also considering the development of plugs loaded with other classes of IOP-lowering medications and therapeutics for dry eye.
“The development of alternative modalities for ophthalmic drug delivery is something of great interest for both physicians and patients considering that traditional drops are accompanied by issues of convenience and voluntary as well as involuntary nonadherence,” said Edward J. Holland, MD, director of cornea services, Cincinnati Eye Institute, Cincinnati, OH, and an investigator in clinical trials for the device.
“An alternative to drops that has proven safety and efficacy and reasonable cost would be appealing to most patients,” he said. “[The device] is a very promising approach to alternative drug delivery. Its design maximizes device retention while assuring targeted delivery to the ocular surface and minimizing systemic absorption.”
In addition, the investigators found the plug easy to insert and replace, Dr. Holland said.