This study is designed to evaluate the safety, tolerability, and ocular pharmacokinetics of topically applied ESBA105 in patients, as well as assess the preventive activity on ocular inflammation resulting from the surgery.
ESBA105 is a single-chain antibody fragment directed against TNF-alpha, a major mediator of inflammation. The study contains a randomized, double-blind, placebo controlled part and is being conducted as a monocentric trial in Switzerland.
The primary objectives of this study are to assess the local tolerability and safety of topical ESBA105 as well as to evaluate its intraocular levels and local biodistribution in the human eye. Secondary objectives include the assessment of the anti-inflammatory potential of prophylactic, topical ESBA105 for prevention of post-surgical inflammation following cataract surgery.
Dominik Escher, CEO of ESBATech, said: “Progress has been lacking in the development of novel treatments for inflammatory ocular conditions. We are very pleased to advance our compound into clinical Phase Ib/IIa, only four months after successful completion of our Phase I trial. We are very confident that our topically available TNF-alpha inhibitor has a great potential in several ophthalmic indications.”