The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration.
The company’s investigational product is a bioresorbable hydrogel fiber implant formulated with a tyrosine kinase inhibitor. The implant is delivered via intravitreal injection, Ocular reported.
In the Phase I trial, researchers plan to evaluate biological activity by assessing retinal thickness and monitoring visual acuity over time.
“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,” CMO Dr. Michael Goldstein said in prepared remarks.
“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,” Goldstein added.
Earlier this year, Ocular announced that it submitted a supplement NDA to the FDA for its dexamethasone ocular insert, Dextenza.
The company requested that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery.