As a renowned glaucoma specialist and cataract surgeon, Nathan Radcliffe, MD, reviews his patient selection process for Durysta and offers insight into dosing guidelines as well as patient education.
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Addressing glaucoma patient non-compliance with Durysta
One of the most challenging and frustrating components of glaucoma management is patient non-compliance. In the words of Dr. Radcliffe, “Patients with poor compliance are untreated glaucoma patients, and untreated glaucoma leads to blindness.”
Fortunately, Durysta provides a solution by alleviating the drop burden associated with topical ophthalmic medications for patients and ophthalmologists alike. Durysta (bimatoprost intracameral implant 10mcg, Allergan, An AbbVie Company), a first-in-class intracameral implant, delivers bimatoprost to the target tissues in the anterior chamber to reduce intraocular pressure (IOP) by increasing aqueous humor outflow.
Through the sustained release of a preservative-free formulation of bimatoprost, it may continue to lower IOP for several months in individuals with open-angle glaucoma (OAG) or ocular hypertension (OHT). Over time, the implant biodegrades within the anterior chamber angle.
Who is a good candidate for Durysta?
In Dr. Radcliffe’s professional opinion, one of the most appealing aspects of Durysta lies in the broad range of patients it is approved for, as indicated in the phase 3 studies and Food and Drug Administration (FDA) guidelines.
It is specified for those with OHT and any level of severity of OAG, regardless of the number of topical ophthalmic eye drops they are currently prescribed by their ophthalmologist.
In addition, both phakic and pseudophakic patients can receive Durysta. Dr. Radcliffe sees pseudophakic patients who have already safely undergone cataract surgery and maintain a healthy endothelium as nearly ideal candidates.
Circumventing non-compliance in glaucoma patients with Durysta
There are two major reasons for patient non-compliance: discomfort and difficulty remembering a regimen. The preservatives and/or active ingredients in many topical ophthalmic eye drops either cause or exacerbate dry eye disease (DED) and its associated symptoms, including irritation, redness, itchiness, and accompanying meibomian gland dysfunction (MGD).
By taking the equivalent of a drop of bimatoprost ophthalmic solution 0.03% and delivering it directly to the target tissue through the Durysta implant, the issues associated with toxicity can be eliminated. The most common reason for non-compliance is simply the inconvenience or forgetfulness factor—the more drops a patient is required to instill on a daily basis—the more likely they are to miss doses or use the medication inaccurately.
Dr. Radcliffe and many of his colleagues have been pleasantly surprised to find that, upon receiving the Durysta implant, patients are able to eliminate at least one drop, often two, and possibly even more. When addressing patients who have undergone selective laser trabeculoplasty (SLT), it is likely they have opted for the procedure due to tolerability or compliance issues.
If an individual has undergone several SLT procedures with each “wearing off,” sustained delivery may be an appropriate next step to help them avoid additional laser treatments, which in some instances could lead to an increase in IOP.
Ongoing studies for ideal dosing of Durysta
Dr. Radcliffe pointed out that when Allergan (An AbbVie Company) initially developed Durysta, the recommended dosing regimen was every 4 months on an ongoing basis. However, clinical studies revealed that three injections over 1 year were unnecessary to achieve the desired results and may be difficult for the eye to endure, so currently, the approach is a single implant.
Phase 1 and 2 studies demonstrated that in a quarter of patients, one injection reduced IOP significantly and lasted for the duration of up to 1 year. Individuals were monitored at the 6-month, 9-month, and 1-year marks. However, the delivery truncates considerably after 6 months. Still, a meaningful fraction of patients were able to maintain a reduced IOP without any other therapy after one sustained dose.
Currently, there are five ongoing studies to determine the ideal dosing schedule for Durysta. Once conclusive data has been gathered and reported to the FDA, it is expected dosing guidelines will be adjusted accordingly. Dr. Radcliffe suspects the FDA indication will either be for one injection per year for several years or one injection on a pro re nata (PRN), treat-and-extend basis.
Further, as Durysta is thought to remodel the uveoscleral outflow pathway, it might ultimately allow patients to avoid any topical therapies for a year or possibly longer.
Patient education on Durysta
When discussing Durysta with patients, Dr. Radcliffe introduces it as a way to address a problem they have previously brought to the forefront. For example, if the patient has formerly complained about irritation, he explains how Durysta could remedy their symptomatology.
He ensures patients that his primary goal is to use the full scope of his expertise and available technologies to help alleviate these symptoms and lower IOP. He also points out that in receiving a break from the topical medications they are currently on, he can then assess the effects those medications were having on the ocular surface.
Next, he notes the fact that many insurance plans cover Durysta, which serves to instill greater confidence in the product as well as encourage patients to seek insurance that covers the latest glaucoma procedures if their current policy does not.
Lastly, he shares the success stories of other patients who have received the Durysta implant and have an improved quality of life (QoL) with fewer drops, improved ocular appearance, and enhanced vision. He relates how his patients have reported no pain post-operatively and were eager to have the implant placed in the second eye as soon as possible.
In conclusion
A lack of compliance is rampant among glaucoma patients, and the results can be devastating, which makes a sustained therapeutic option a welcomed solution.
Ultimately, for doctors treating glaucoma, Durysta offers a countermeasure to the ongoing issue of non-compliance and allows them to potentially have greater control over outcomes.
For patients, it offers freedom from drops with an ongoing reliable dose of bimatoprost, thus lessening the day-to-day drop burden and the possible risk of vision loss.
Disclaimer: Durysta (bimatoprost intracameral implant) 10mcg from Allergan is a dissolvable, preservative-free ocular implant indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. The medical opinions and views expressed in this article are those of Nathan Radcliffe, MD.
