Official ESCRS | European Society of Cataract & Refractive Surgeons


Safety and efficacy of a novel integrin inhibitor ALG-1007 topical ophthalmic solution for the treatment of dry eye disease

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Session Details

Session Title: Cornea: Medical

Session Date/Time: Monday 16/09/2019 | 08:30-10:30

Paper Time: 09:48

Venue: Free Paper Forum: Podium 2

First Author: : E.Holland USA

Co Author(s): :    E. Donnenfeld   R. Lindstrom   A. Vardanyan   T. Adamyan   L. Karageozian   J. Aubel              

Abstract Details


ALG-1007 is a small synthetic peptide integrin inhibitor that interferes with Complement component 3, leukocyte adhesion and trans-endothelial migration which results in downregulation of inflammation. Preclinical studies demonstrated the reduction of cytokines associated with DED after treatment with ALG-1007. The purpose of this dose ranging study is to determine safety and dose response effect of ALG-1007 in patients with DED.


Single site, hospital-based practice, multi-specialty clinic


Prospective, open-label study human clinical trial. 40 eyes diagnosed with DED for at least 6 months were enrolled and assigned to 1 of 4 treatment doses (n=10, each group): 0.125, 0.25, 0.4 and 0.6% of ALG-1007 (Allegro Ophthalmics, San Juan Capistrano, CA) in a lubricating ophthalmic topical solution, 1 drop 2xday. Subjects were followed at weeks 1, 2, 4, 6, 8, 10 and 12. Outcome measures were: tear break up time (TBUT), SICCA total ocular staining score (0=no staining, 12=severe), corneal and nasal conjunctival staining score (0=no staining, 3=severe), and reported symptoms using the visual analog scale (VAS) symptom index.


Mean change from baseline (CFB) in TBUT were 2.0, 3.4, 0.5 and 6.7 secs in groups 0.125, 0.25, 0.4 and 0.6%, respectively. The mean CFB in nasal conj staining were -0.2, -0.7, -0.9, and -1.6, respectively. The mean CFB in cornea staining were -0.9, -1.4, -0.1, and -1.4, respectively. The mean CFB in total ocular staining were -1.5, -3.5, -2.5, and -5.1, respectively. The symptom score correlated negatively with TBUT and positively with the other 3 measures. The dose difference between 0.125 and 0.6% in TBUT, nasal and total staining were significantly greater at the high dose (p < 0.05).


This study demonstrates that ALG-1007 exhibits a dose response curve with clinical and statistically significant efficacy in multiple objective and subjective measures. Although the study does not have a vehicle control, the results indicate that the active ingredient (not the vehicle) is effective in improving signs and symptoms of DED in a statistically significant manner when comparing the 0.125% dose vs the 0.6% dose. The drug was well-tolerated with no drug-related SAEs, blurring of vision nor ocular irritation. A Phase 2 study has been initiated using higher doses. Results from the study will also be presented.

Financial Disclosure:

is employed by a competing company, receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

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