Ocular Therapeutix has dosed the first patient in a phase 1 trial of tyrosine kinase inhibitor implant (OTX-TKI) in patients with wet age-related macular degeneration (AMD).
Ocular Therapeutix said that the first patient was dosed at the Sydney Retina Clinic in Sydney, Australia.
The company said that the phase 1 trial will be a multi-center, open-label study to test the safety, durability and tolerability of OTX-TKI, a bioresorbable hydrogel fiber implant formulated with a tyrosine kinase inhibitor delivered by intravitreal injection to patients with wet AMD.
OTX-TKI is an injectable fiber that can be delivered through a small-gauge, sterile injection needle to the back of the eye. It is touted to have been designed to deliver drugs to the target tissues for a period of up to nine months, thereby potentially extending the dosing interval from the one – to two – month frequency needed with the current standard of care.
Preclinical data has shown that OTX has the ability to deliver TKI to the posterior segment of the eye with sustained pharmacokinetic/pharmacodynamic effect for the treatment of VEGF-induced retinal leakage for a period of up to twelve months.
The present study will evaluate the biological activity by measuring retinal thickness with the help of standard optical coherence tomography, followed by visual acuity over time.
Ocular Therapeutix chief medical officer Michael Goldstein said: “We are excited to announce the first patient has been successfully dosed in our Phase 1 program with OTX-TKI, our tyrosine kinase inhibitor implant for the treatment of serious retinal disease. Our trial is primarily intended to demonstrate safety, but we will also evaluate biological activity in patients with increased retinal thickness and measure whether there are decreases over time.
“Given that TKI’s act upstream of VEGF inhibitors, we believe this Phase 1 trial may bring us one step closer to understanding whether TKI’s may represent a next-generation treatment for wet AMD and diabetic macular edema.”
Last month, the company submitted supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for dexamethasone ophthalmic insert (DEXTENZA).
The sNDA filing aims to expand the current indication for DEXTENZA to include the treatment of ocular inflammation after ophthalmic surgery. The FDA is expected to complete the review in the second half of this year.
The company claims that DEXTENZA is the first FDA-approved intracanalicular insert delivering dexamethasone for treating post-surgical ocular pain for up to 30 days with a single administration.
DEXTENZA, which is a resorbable, preservative-free ophthalmic insert placed in the lower lacrimal punctum and into the canaliculus of the eye, received FDA approval last November.