Glaukos’ intraocular implant has performed comparably to topical timolol in the 24-month interim analysis of glaucoma patients enrolled in a phase 2b trial. The study is part of Glaukos’ preparations for a planned filing for FDA approval of the iDose TR sustained-release implant.
Investigators randomized 154 people to receive a fast- or slow-release version of the iDose TR implant or use topical timolol ophthalmic solution twice a day. The implant is designed to release a formulation of the prostaglandin analog travoprost for at least one year and, in doing so, reduce intraocular pressure (IOP).
The interim analysis of the phase 2b provides evidence to support the product. After 24 months, IOP in patients who received a single fast- or slow-release iDose TR implant had fallen 7.9 mmHg and 7.4 mmHg, respectively, as compared to a 7.8-mmHg decline in the control group.
Glaukos’ implants performed at least comparably to the topical control against other endpoints, too. In the two implant arms, more than 20% of subjects experienced a 40% or greater average reduction in IOP over the first 24 months of the trial. Thirteen percent of patients on the topic timolol control experienced such an improvement.
The limited safety information shared by Glaukos is positive. Glaukos said there was no clinically significant corneal endothelial cell loss, no serious corneal adverse events and no adverse events of conjunctival hyperemia in either of the implant cohorts.
Glaukos is working to complete the 36-month phase 2b while enrolling participants in phase 3 trials of its iDose TR product. COVID-19 has affected enrollment in the phase 3 trial, meaning Glaukos now expects to bring the product to the U.S. market in 2023. Data from the phase 3 are due next year.
Like the phase 2b, the phase 3 trials are designed to show the non-inferiority of iDose TR to topical timolol. Glaukos is seeking to position the implant as a way to spare patients from the need to take twice-daily eye drops and, in doing so, improve adherence to treatment.