Eyeworld

I REVOLUTION IN GUCOMA MEDICATIONS N FOCUS 52 | EYEWORLD | MAY 2020 by Liz Hillman Editorial Co-Director "I think it's the way of the future, and I like to offer my patients something that can manage their glaucoma and make it easier for them to adhere to treatment," she said. Products in the pipeline In addition to Durysta, there are other products that hope to provide sustained-release medica- tion to glaucoma patients in the future through different modes of delivery. One is iDose (Glaukos), a travoprost-elut- ing implant that is injected into the anterior chamber. Phase 2 data shows an average IOP reduction of 7.9–8.5 mm Hg 12 months after injection. 1 According to the company's study, the group that received timolol required 31% more medications compared to those in fast-elution and slow-elution iDose cohorts. iDose is expected to be introduced in the U.S. market in 2021–22, Dr. Williamson said. Dr. Williamson said that iDose will at least require taking a patient into a minor procedure room, because it is injected under a gonioscopic view of the angle through the trabecular mesh- work into Schlemm's canal. "It's very similar to how an iStent inject [Glaukos] is delivered," he said, adding that there is promising data that this device could be eluting the IOP-lowering drug beyond 1 year. Another drug delivery option in the works is a bimatoprost-eluting ring (Allergan), an ocular surface insert that fits around the ocular fornix. This ring completed Phase 2 clinical tri- als a few years ago, with data published in 2016, showing a reduction of 3.2–6.4 mm Hg from baseline (compared to a reduction of 4.2–6.4 mm Hg in the timolol group) over a 6-month period. 2 In addition, Brandt et al. looked at 13 months of two cycles of using the bimatoprost ring. 3 Safety, according to the study authors, was good, and patients reported the ring to be comfortable or at least tolerable. The median IOP reduction in the 13 months of follow-up was 4 mm Hg. Punctal plugs are already being used to elute steroids after cataract surgery for man- agement of pain and postop inflammation, but F irst, glaucoma saw an explosion in MIGS innovation. Is sustained release for medications next? Few areas of ophthalmology could benefit more from sustained-release medications than the glaucoma com- munity. Compliance estimates for tradi- tional drop therapy vary, but most physicians in the 2019 ASCRS Clinical Survey think 31% of patients, on average, are noncompliant on one topical glaucoma therapy. Such noncompliance can result in progression of the disease, poten- tially leading to irreversible vision loss. There is only one FDA-approved sustained- release product for glaucoma treatment, but several are in the pipeline. "Nearly zero percent of patients are 100% compliant," said Blake Williamson, MD. "When you have the ability to take that out of their hands, it's going to be a win every time." First FDA-approved product Durysta (Allergan) received FDA approval in March as an intracameral bimatoprost implant. According to the company, the biodegradable pellet contains 10 mcg of the prostaglandin analog, which is delivered via a preloaded, sin- gle-use injector. Clinical trials with the product showed that it performed similarly to 0.5% timolol drops for patients with open angle glaucoma or ocular hypertension, and it resulted in a 5–8 mm Hg IOP reduction from a mean 24.5 mm Hg baseline. In terms of safety, the most common adverse event was conjunctival hyperemia (27% of patients). Dr. Williamson said what's nice about Durysta is that it can be placed at the slit lamp in the office. "The idea is patients can go every 3–4 months to see their eyecare provider, pop in one of these pellets, and you have sustained-re- lease prostaglandin analog in the eye," he said. Lama Al-Aswad, MD, was involved in early clinical trials for Durysta and said she would be using it on some of her glaucoma patients now that it's FDA approved. Sustained-release making inroads in glaucoma At a glance • The first sustained-release medication for glaucoma, an intracameral implant, was approved by the FDA in March. • Other products in the pipeline are looking at sustained drug delivery in the form of a ring, punctal plugs, gel-forming drops, injectable drugs, and more. • Ophthalmologists think that many options for sustained drug delivery will allow them to tailor choices to meet patient needs.

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