The Safety and Biological Activity of OTT166, a Novel Topical Selective Integrin Inhibitor for the Treatment of Diabetic Eye Disease A Phase 1b Study

The Safety and Biological Activity of OTT166, a Novel Topical Selective Integrin Inhibitor for the Treatment of Diabetic Eye Disease : A Phase 1b Study

BACKGROUND AND OBJECTIVES: To evaluate the safety, tolerability, and biological activity of a topical selective integrin inhibitor (OTT166) eyedrop administered BID for diabetic retinopathy (DR) and diabetic macular edema (DME)

Bibliographische Detailangaben
Veröffentlicht in:Ophthalmic surgery, lasers & imaging retina. - 2013. - 53(2022), 10 vom: 17. Okt., Seite 553-560
1. Verfasser: Boyer, David S (VerfasserIn)
Weitere Verfasser: Kaiser, Peter K, Magrath, George N, Brady, Kerrie, Edwards, Scott, Tanzer, David J, Heier, Jeffrey S
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2022
Zugriff auf das übergeordnete Werk:Ophthalmic surgery, lasers & imaging retina
Schlagworte:Clinical Trial, Phase I Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Integrins Ophthalmic Solutions
Beschreibung
Zusammenfassung:BACKGROUND AND OBJECTIVES: To evaluate the safety, tolerability, and biological activity of a topical selective integrin inhibitor (OTT166) eyedrop administered BID for diabetic retinopathy (DR) and diabetic macular edema (DME)
STUDY DESIGN/MATERIALS AND METHODS: A prospective, multicenter, randomized, double-masked Phase 1b study. Subjects with nonproliferative DR and DME with central subfield thickness (CST) > 325 microns were randomized to OTT166 eyedrops (2.5% or 5%) BID for 28 days. Subjects were followed for an additional 28 days after treatment cessation
RESULTS: Forty-four subjects were enrolled. No drug-related serious adverse events (SAEs) and two drug-related adverse events (AEs) were reported. OTT166 was well-tolerated with no evidence of ocular toxicity. Best-corrected visual acuity (BCVA) remained stable. Mean central retinal thickness (CRT) overall was variable: +12.8/+1.8 microns at Day 28 (end of treatment) and -50.3/+5.5 microns at Day 56 (end of study) for the 2.5% and 5% groups, respectively. Median CRT overall demonstrated consistent reduction by end of study: -39.0/-16.5 microns for the 2.5% and 5% groups, respectively. Median responses were greater in the treatment-naïve group (-41.5/-26.0 microns for the 2.5% and 5% groups, respectively). Thirty-seven percent of 'responder' subjects exhibited a mean reduction in CRT of 46.6 microns on optical coherence tomography (OCT) at end of treatment (Day 28) which persisted to end of the study (Day 56) - mean reduction of 67.4 microns, suggesting a durable effect
CONCLUSION: OTT166 eyedrops were safe, well-tolerated, and demonstrated biological activity in 37% of responders. These results warrant further evaluation of OTT166 eyedrops. <b>[<i>Ophthalmic Surg Lasers Imaging Retina</i> 2022;53:553-560.]</b>
Beschreibung:Date Completed 20.10.2022
Date Revised 15.11.2022
published: Print-Electronic
Citation Status MEDLINE
ISSN:2325-8179
DOI:10.3928/23258160-20220923-02