Positive Phase 1 Results With Liquid Sustained-Release Drug Delivery Platform

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The Verisome drug delivery system (Icon Biosciences) was safe and provided controlled, extended release of triamcinolone acetonide (TA) in a phase 1 study, said Anne Fung, MD, a Clinical Professor of Ophthalmology at the California Pacific Medical Center, at the Angiogenesis 2010: Clinical Trials Conference.¹

The Verisome system is a liquid, biodegradable, sustained- release platform administered through a standard 30-gauge injection. It is capable of delivering a variety of drug types (eg, steroids, antibiotics, nonsteroidal antiinflammatory drugs, monoclonal antibodies, proteins) to the retina for a prescribed length of time. Both the drug and the platform degrade at an even rate, according to Dr. Fung.

She and colleagues conducted a phase 1, open-label study to evaluate the safety of the Verisome system. Patients (n=10) enrolled had macular edema due either to retinal vein occlusion (RVO) or to pseudophakia. Patients who were known steroid responders or glaucoma patients were excluded.

The patients were treated with a single intravitreal injection of Verisome containing TA through a 30-gauge needle in two sequential cohorts of five patients each. The first cohort received a lower dose containing 6.9 mg TA with sustained delivery calculated to last for 6 months, and the second cohort received a higher dose containing 13.8 mg TA calculated to last for 12 months. When the first cohort cleared the safety endpoint at day 60, the second cohort was treated. Both dosages provided the same concentration of TA (approximately 1.75 µg/mL) with duration dependent on volume given. Follow-up visits to assess the safety and efficacy of the drug delivery system were conducted at days 1 and 7, and at months 1, 2, 4, 6, 9, and 12.

“As the primary outcome was safety, we were pleased that there were no cases of endophthalmitis or cases with injection-related events,” Dr. Fung said. “There were two cases of neovascularization; one patient required surgery; another patient required pan-retinal photocoagulation and topical therapy. There was one death in the cohort, but this happened well after the 6-month mark and it was unrelated.”

Due to extensive macular edema in cohort 1, Dr. Fung and colleagues had difficulty obtaining accurate optical coherence tomography (OCT) measurements of the biologic effect on retinal thickness over time. Cohort 2, Dr. Fund said, was easier to observe, and showed a biologic effect as early as day 7 that was maintained through day 180. Following day 180, one patient showed increased thickness and the other four remained stable.

A phase 2 study of the Verisome system is planned, Dr. Fund said.

1. Fung A. Presentation on the Versiome drug delivery system. Paper presented at: Angiongenesis 2010: Clinical Trials; February 20, 2010; Miami, FL.

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