Sustained-Delivery TKI Inhibitor Significantly Reduces Treatment Burden in Wet AMD

A sustained delivery drug may offer a new option for patients with wet AMD.

An ongoing, 12-month study found that a sustained-delivery tyrosine kinase inhibitor (TKI), EYP-101, both has a favorable safety profile across several dosages, and can control neovascular (wet) age-related macular degeneration (AMD) for at least 6 months, according to findings presented at the American Academy of Ophthalmology (AAO) 2022 annual meeting, held in Chicago from September 30 to October 3.

The study was conducted to evaluate the safety of EYP-1901. Researchers utilized data from DAVIO (ClinicalTrials.gov Identifier: NCT04747197), a multicenter, open-label, dose-escalation trial of the sustained-delivery TKI drug in patients with previously treated wet AMD. With this method, primary endpoints are rates of ocular and systemic adverse events, and secondary endpoints include best corrected visual acuity and key optical coherence tomography (OCT) measurements. 

Seventeen patients are enrolled in the study and have received 440 µg, 1,060 µg, 2060 µg or 3090 µg of EYP-1901. To date, reported adverse events have been nondrug related and mostly mild. Both visual acuity and OCT were stable. After a single dose of EYP-1901, 53% of eyes were rescue free for up to 6 months and 41% for up to 8 months. 

Researchers note a 79% reduction in treatment burden at 6 months. This study is ongoing and will last for a total of 12 months, however the current findings indicate that EYP-1901 had a favorable safety profile in the doses tested and controlled wet AMD.

Disclosure: Multiple study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

References:

Lally D, Singh R, Barakat M, et al. EYP-1901: an open-label, dose-escalation study demonstrating reduced wet amd treatment burden with sustained TKI inhibition. Poster presented at: The American Academy of Ophthalmology (AAO) 2022 annual meeting; September 30 to October 3; Chicago. PO344