Allegro Ophthalmics Announces Positive Results of Vehicle-controlled Ex-U.S. Phase 2 Trial of ALG-1007 for the Treatment of Dry Eye Disease
24 Juli 2021 - 10:45PM
Business Wire
Allegro also announces FDA acceptance of IND
for ALG-1007 for dry eye disease, clearing path to initiate Phase
2b/3 U.S. study
Allegro Ophthalmics, LLC, a privately held biopharmaceutical
company focused on the development of novel oxidative stress
stabilizers for the treatment of ocular diseases, today announced
that all primary and secondary endpoints of an ex-U.S.
vehicle-controlled study of ALG-1007 topical eye drop in patients
with dry eye disease (DED) were met. The results were presented by
Eric D. Donnenfeld, M.D., at the 2021 American Society of Cataract
and Refractive Surgery and American Society of Ophthalmic
Administrators (ASCRS ASOA) Annual Meeting in Las Vegas.1
The study authors determined ALG-1007, a fixed combination of
0.6% risuteganib and 0.125% sodium hyaluronate in a vehicle
solution, demonstrated the highest efficacy among four study arms
(p<.001) comprising various combinations of the solution
components. No adverse events, ocular irritation, or prolonged
blurring of vision were reported in the study. Compared with
patients in the control arms, patients who received ALG-1007
experienced statistically significant better results in tear
break-up time, inferior corneal staining, and scores on the dry eye
management scale and visual analog scales. Statistical significance
versus the control was seen as early as 2 weeks.
The company also announced that the U.S. Food and Drug
Administration (FDA) accepted the filing of an Investigational New
Drug (IND) application for ALG-1007, paving the way for Phase 2b
clinical development in the U.S.
“Allegro is happy to share the results of our second ex-U.S.
clinical trial, which continue to suggest that ALG-1007 improves
the signs and symptoms of dry eye,” said Vicken Karageozian, M.D.,
President and CEO of Allegro Ophthalmics. “These results support
the development of a U.S.-based phase 2b/3 study. These data,
coupled with the FDA’s acceptance of Allegro’s IND application,
will allow investigators to collect more data to elucidate our
understanding of how ALG-1007 may provide relief to patients with
dry eye, a disease that adversely affects millions of people
worldwide.”
“I’m very encouraged by the results of this trial, which
demonstrated that ALG-1007 had the most robust improvement in signs
and symptoms of dry eye compared to the comparator arms,” said Dr.
Donnenfeld, founding partner of Ophthalmic Consultants of Long
Island and Clinical Professor of Ophthalmology at NYU. “The
components in ALG-1007 appear to have synergistic effects. It
should be emphasized that no adverse events, ocular irritation, or
prolonged blurred vision were reported in the study—an impressive
finding.”
The prospective, randomized, double-masked, vehicle-controlled
study was conducted in Armenia. Researchers randomly assigned
patients to one of four arms (64 eyes total; 16 eyes per arm):
vehicle; vehicle and 0.125% sodium hyaluronate; vehicle and 0.6%
risuteganib; and ALG-1007, which contains vehicle, 0.125% sodium
hyaluronate, and 0.6% risuteganib. Patients struggling with dry eye
signs and symptoms for at least 6 months received 1 drop twice
daily for 12 weeks, at which point data were collected and
analyzed. Exclusion criteria included history of ocular herpetic
keratitis, LASIK surgery, or use of glaucoma medication; any ocular
surgery in the past 6 months; and current use of DED therapy.
All educational content of the ASCRS•ASOA Annual Meeting is
planned by its program committee, and ASCRS ASOA does not endorse,
promote, approve, or recommend the use of any products, devices, or
services.
About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical
company focused on the development of novel oxidative stress
stabilizers for the treatment of ocular diseases. Pre-clinical data
suggest that risuteganib (Luminate®), Allegro’s lead
investigational compound in retina, may simultaneously act on the
angiogenic, inflammatory and mitochondrial metabolic pathways
implicated in diseases, such as dry AMD. A U.S. Phase 2a study with
risuteganib in less advanced dry AMD met its primary endpoint of
vision recovery. Expanding its oxidative stress-stabilizing
portfolio, Allegro developed ALG-1007 for topical use in dry eye
disease. ALG-1007 demonstrated promising results in two ex-U.S.
studies in humans. For more information, visit
www.allegroeye.com.
Risuteganib (Luminate®) and ALG-1007 are investigational drugs
and are not approved for commercial sale.
Luminate® is a registered trademark of Allegro Ophthalmics,
LLC.
Source:
- Donnenfeld E, Holland E, Lindstrom R, et al. Prospective,
Randomized, Double-Masked, Vehicle-Controlled Study to Evaluate the
Safety and Efficacy of Topical Risuteganib (ALG-1007) in the
Treatment of Dry Eye Disease. 2021 ASCRS•ASOA.
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