PolyActiva’s glaucoma implant has cleared an early clinical test. With the study linking the lowest dose of the biodegradable implant to improved outcomes, PolyActiva is preparing to move deeper into the clinic.
Investigators assigned 30 adults with primary open angle glaucoma to receive one of three doses of the latanoprost implant to evaluate the minimum effective dose. PolyActiva defined the minimum effective dose in terms of ability to lower intraocular pressure (IOP) by at least 20% with minimal adverse events. The trial took mean diurnal IOP at weeks 12 and 26 and IOP at 8 a.m. at weeks 6, 18 and 21.
In disclosing the top-line data from the low-dose cohort, PolyActiva said it saw a statistically significant reduction versus baseline of a 20%-or-greater IOP-lowering effect across all assessment visits, with the p-values ranging from 0.001 to 0.01. Statistically significant changes in diurnal IOP were recorded at weeks 12 and 26.
The implants persisted for at least 21 weeks and fully biodegraded by Week 40, with the breakdown taking place over a four- to six-week period. That profile is attractive to Ike Ahmed, M.D., an ophthalmologist at the Prism Eye Institute.
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“An implant that enables a repeat dose of treatment with a low-dose, constant daily drug release over the course of 20 weeks and is fully biodegradable while being well tolerated is highly desirable. These data demonstrate that the PA5108 Ocular Implant with Prezia Technology holds the promise to deliver a target profile that allows me to better manage the progression of glaucoma for patients in my clinical practice,” Ahmed, who has worked as a consultant to PolyActiva, said in a statement.
PolyActiva said the low-dose implant, which releases 14.7 mcg of the drug, was generally well tolerated. No patients suffered ocular serious adverse events related to the product, endothelial cell loss or implant movement.