Novel implants show promise in drug delivery
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KIAWAH ISLAND, S.C. — Drug-eluting implants in various stages of study and approval may provide efficient, sustained drug delivery, overcoming barriers to penetration, according to a speaker at Kiawah Eye.
“Only 0.001% of a topical drug is thought to be accessing the retina, and 5% accesses the anterior segment. And then there are the other barriers to entry: patient confusion, poor compliance, challenges with instillation of drops, side effects yielding poor compliance and perhaps premature discontinuation of drops,” Neel R. Desai, MD, said.
One technology that is FDA approved for glaucoma and ocular hypertension is iDose TR (Glaukos), a small non-bioerodible device designed to be implanted in Schlemm’s canal for continuous elution of travoprost. Topline clinical data showed noninferiority to timolol over 3 months, with a 5.8 mm Hg reduction of IOP.
“Over 12 months, 81% of iDose TR subjects were completely free of their IOP drops topically, and 69% of those patients had a continued IOP-lowering benefit at 3 years compared to timolol,” Desai said.
The SpyGlass implant (SpyGlass Pharma) is a single-piece hydrophobic acrylic IOL with two drug-eluting pads that slide over the haptics. It is a large reservoir designed to elute bimatoprost for up to 3 years.
“In a phase 1 trial, 23 subjects in low, mid and high dosing showed comparable results with all three doses with a 44% mean IOP reduction. All these patients were off topical drops,” Desai said.
The Gemini capsule (Omega Ophthalmics) is a multifunctional system that acts as a scaffold for IOLs and serves as a platform for drug delivery technologies.
Finally, the OcuRing (LayerBio) is a bioerodible sustained-release implant that is applied to the IOL haptic during cataract surgery and elutes ketorolac. In a phase 1 study, it was tested in five patients.
“All these patients were clear of any inflammation, no steroids were given per the protocol, and no study patient required rescue therapy,” Desai said.
The OcuRing could be adapted to elute a combination of NSAIDs and corticosteroids or antibiotics, allowing for drop-free cataract surgery.