Clinical trial to evaluate safety, efficacy of sustained-release drug delivery implant for glaucoma
MILAN — A phase 2a clinical trial will evaluate the safety, tolerability and efficacy of an intracameral implant for sustained delivery of a prostaglandin formulation in patients with ocular hypertension or early glaucoma.
ENV515 (Envisia Therapeutics) is made of a biodegradable polymer containing travoprost and has successfully undergone preclinical studies, showing sustained IOP lowering efficacy for up to 8 months after a single dose, Jay S. Pepose, MD, PhD, said at the annual joint meeting of Ocular Surgery News and the Italian Society of Ophthalmology.
Jay S. Pepose
“The clinical trial includes 20 patients with bilateral ocular hypertension or early open-angle glaucoma and cataract. Following a washout period of 4 weeks, patients will be randomly assigned to implantation of the ENV515 sustained delivery system in two sizes and dosages in one eye, while topical travoprost will be administered in the fellow eye. Patients will be followed for 4 weeks, monitoring IOP and potential side effects. Then cataract surgery will be performed and the implant retrieved, allowing pharmacokinetics analysis of travoprost levels in the aqueous humor, systemic exposure and residuals in the implant after surgery,” Pepose said.
This technology, which promises to be safe and noninvasive, would represent a major step forward in the treatment of glaucoma, “taking the bottle out of the patient’s hands” and thus overcoming the well-known compliance issues that hinder the success of glaucoma therapy.
“It would allow stable, well-controlled IOP levels, avoiding the peak and trough drug levels in the aqueous humor associated with once-a-day therapy,” Pepose said. - by Michela Cimberle