The nepafenac punctal plug drug delivery system (PPDS) was found to be safe and effective for reducing pain and inflammation associated with cataract surgery in a phase II FDA study.
Overcoming topical treatment challenges
Current treatment with topical medications suffers from many limitations. Efficacy depends on medication bioavailability and being used as directed. Conventional topical medications do not maintain a steady therapeutic concentration level of medication at the target site and patient compliance can be poor.
Some patients may not even fill their prescription because of the medication’s cost and some may have trouble instilling ophthalmic medications. Difficulty with the use of ophthalmic drops can be a particular problem in the cataract surgery population as older individuals are more likely to have arthritis or neurological conditions affecting their manual dexterity, Dr. Donnenfeld said.
Safety is also an issue with topical drops because they contain preservatives that can cause or exacerbate ocular surface disease, which is common in older individuals.
The nepafenac PPDS, which is being developed by Mati Therapeutics using its proprietary punctal plug platform (Evolute) for sustained drug delivery, can address the above issues. Made of non-biodegradable medical grade silicone, the L-shaped plug is well-tolerated and preservative-free. It is placed and removed by the ophthalmologist as an in-office procedure and delivers a consistent level of medication for one month of sustained efficacy.
“The PPDS is easy to insert and take out, and once inserted, it is cosmetically invisible. The PPDS has demonstrated excellent retention, but its presence in the punctum is also easy to confirm with eversion of the lower lid,” said Dr. Donnenfeld, who was principal investigator of the phase II nepafenac PPDS study.
Eric D. Donnenfeld, MD
This article is based on a presentation given by Dr. Donnenfeld at the 2019 ASCRS Symposium. Dr. Donnenfeld is a consultant to Mati Therapeutics and to other companies that are developing or market ophthalmic anti-inflammatory products.