PMID- 36239675
OWN - NLM
STAT- MEDLINE
DCOM- 20221020
LR  - 20221115
IS  - 2325-8179 (Electronic)
IS  - 2325-8160 (Linking)
VI  - 53
IP  - 10
DP  - 2022 Oct
TI  - The Safety and Biological Activity of OTT166, a Novel Topical Selective Integrin 
      Inhibitor for the Treatment of Diabetic Eye Disease: A Phase 1b Study.
PG  - 553-560
LID - 10.3928/23258160-20220923-02 [doi]
AB  - 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-naive 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>.
FAU - Boyer, David S
AU  - Boyer DS
FAU - Kaiser, Peter K
AU  - Kaiser PK
FAU - Magrath, George N
AU  - Magrath GN
FAU - Brady, Kerrie
AU  - Brady K
FAU - Edwards, Scott
AU  - Edwards S
FAU - Tanzer, David J
AU  - Tanzer DJ
FAU - Heier, Jeffrey S
AU  - Heier JS
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20221001
PL  - United States
TA  - Ophthalmic Surg Lasers Imaging Retina
JT  - Ophthalmic surgery, lasers & imaging retina
JID - 101599215
RN  - 0 (Integrins)
RN  - 0 (Ophthalmic Solutions)
SB  - IM
MH  - Humans
MH  - *Diabetic Retinopathy/drug therapy
MH  - *Integrins/antagonists & inhibitors
MH  - *Macular Edema/drug therapy
MH  - *Ophthalmic Solutions/adverse effects
MH  - Prospective Studies
EDAT- 2022/10/15 06:00
MHDA- 2022/10/19 06:00
CRDT- 2022/10/14 10:44
PHST- 2022/10/14 10:44 [entrez]
PHST- 2022/10/15 06:00 [pubmed]
PHST- 2022/10/19 06:00 [medline]
AID - 10.3928/23258160-20220923-02 [doi]
PST - ppublish
SO  - Ophthalmic Surg Lasers Imaging Retina. 2022 Oct;53(10):553-560. doi: 
      10.3928/23258160-20220923-02. Epub 2022 Oct 1.