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conferenceseries.com
July 17-19, 2017 Chicago, USA
World Congress and Expo on
Optometry & Vision Science
Volume 2, Issue 1 (Suppl) Optom Open Access, an open access journal
ISSN:2476-2075 World Optometry 2017
July 17-19, 2017
integrin—α3β1—and, by doing so, aids in the breakdown of vitreous and its separation from the retina. This separation should
move the hypothesized VEGF depot away from the retina, which would, in theory, prevent further damage.
Phase 2 Studies: ALG-1001 is being evaluated in several ongoing studies. DEL MAR is a phase 2b study evaluating ALG-1001
as monotherapy, as well as in combination therapy with anti-VEGF agents, and as a treat-and-maintain therapy. According to
the manufacturer, results are anticipated as early as Q4 2016. DEL MAR has enrolled almost 120 patients. Efficacy endpoints
include mean change in visual acuity and central retinal thickness (as measured by optical coherence tomography) at weeks
16 and 20. The study is evaluating 1.0, 2.0, and 3.0 mg of ALG-1001 in comparison with bevacizumab (Avastin, Genentech). A
second arm of the study is evaluating ALG-1001 as an adjunctive therapy after treatment with any anti-VEGF agent, and a third
arm is evaluating ALG-1001 in combination with bevacizumab. The last two arms are enrolling an additional 75 patients. The
PACIFIC study is another phase 2b trial, enrolling about 100 subjects with nonproliferative DR without PVD to evaluate ALG-
1001 as a standalone therapy. The trial will assess whether induction of PVD can inhibit progression to PDR. The PACIFIC trial
will evaluate four doses of ALG-1001: 1.0, 2.0, 3.0, and 4.0 mg, with balanced saline solution as a placebo. Results from PACIFIC
are expected in the first half of 2017, according to the manufacturer. The main endpoint is PVD induction based on optical
coherence tomography and/or B-scan ultrasound. Another prospective, randomized, double-masked phase 2b study evaluated
ALG-1001 in patients with vitreomacular adhesion (VMA) and VMT. Topline results indicate that this study met its endpoint,
with 50% of patients who received the highest dose of ALG-1001 achieving release of VMT or VMA by day 90, compared with
9.7% of those receiving saline solution as placebo (P =.0129). The study randomly assigned 106 patients to receive ALG-1001
2.0, 2.5 mg, 3.2 mg, or placebo. The drug was well tolerated, with no drug-related toxicity or inflammation noted with repeated
injections.
Conclusions: It is hoped that the reporting of the full datasets of these studies will reinforce the concept that, although these
are small studies, ALG-1001 appears to be effective in a significant subset of patients with AMD or DME. The larger VMT
study seems to suggest that ALG-1001 can effect vitreous release in a significant subset of patients. ALG-1001 shows promising
efficacy, with mechanisms of action that are distinct from those of anti-VEGF therapy. This gives hope that the compound may
become a new weapon in our armamentarium that may be complementary or additive to anti-VEGF therapy. If the results from
DEL MAR, PACIFIC, and other future studies confirm early findings, ALG-1001 may become a viable alternative approach to
both pharmacologic vitreolysis and treatment of AMD, DME, and DR.
Biography
Hugo Quiroz-Mercado is an Ophthalmologist specializing in Diabetic Retinopathy and Retinopathy Prematurity as the Director of Ophthalmology Service at Hugo
Quiroz-Mercado. With over 25 years of practice experience, he has held previous appointments as the Director of the Retina Department and Chief of the Experimental
Surgery Laboratory at Luis Sanchez Hospital for the Prevention of Blindness, as well as Professor of Ophthalmology at the Facultad de Medicine Universidad Autonoma
de Mexico..