Several biodegradable sustained-release (SR) device concepts, from drug-eluting contact lenses to lacrimal inserts and intracameral implants, have been put forward in recent years as a means of lowering intraocular pressure (IOP) in the treatment of glaucoma. To be successful, though, these devices must prove that they can achieve their proposed benefits — increasing compliance and potentially stabilizing IOP peaks and troughs — without posing any significant additional risks. One such device has now met these criteria.
In March 2020, the US Food and Drug Administration approved the first intracameral biodegradable SR implant, the bimatoprost implant (Durysta), which will be commercially available this June.
Approval was based on published phase 1/2 trials and two phase 3 trials (known as ARTEMIS) that have yet to release data in the peer-reviewed literature. According to a press release describing the phase 3 results, however, the implant demonstrated an approximately 30% decrease in IOP from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator.
The published phase 1/2 data included 75 patients with open-angle glaucoma and a history of a minimum of 20% IOP-lowering response to a topical prostaglandin analog. Four doses of the bimatoprostSR implant (6, 10, 15, or 20 µg) were studied; the fellow eye was treated with topical bimatoprost 0.03% once daily. If additional medication was needed, either a topical rescue medication or a single repeat implant was permitted.
