Allegro Ophthalmics Announces Positive Results of Ex-U.S. Proof-of-Concept Trial with Integrin Inhibitor ALG-1007 for Dry Eye Disease

Results of the Trial Suggest that ALG-1007 is Well-Tolerated and
Demonstrates a Dose Response with Improvement as Early as Two Weeks

SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/ASCRS?src=hash" target="_blank"gt;#ASCRSlt;/agt;–Allegro
Ophthalmics, LLC, a privately held biopharmaceutical company focused
on the development of novel anti-integrin therapies for the treatment of
ocular diseases, today announced positive results of an ex-U.S.
proof-of-concept clinical trial of the new investigational ALG-1007
topical drop drug candidate in patients with dry eye disease (DED). The
results were presented by Eric D. Donnenfeld, M.D., last week at the
2019 American Society of Cataract and Refractive Surgery and American
Society of Ophthalmic Administrators (ASCRS•ASOA) Annual Meeting in San
Diego, CA.¹

The ex-U.S. proof-of-concept clinical trial concluded that ALG-1007
demonstrated a dose response, indicating that the active pharmaceutical
ingredient (API) in ALG-1007 is effective in improving the signs and
symptoms of DED with improvement as early as two weeks. At the highest
dose concentration (0.6%), ALG-1007 demonstrated statistically
significant efficacy in nearly all assessments and a more rapid onset of
action compared to the lowest dose (0.125%). ALG-1007 was well-tolerated
with no drug-related adverse events, even at the highest dose, and there
was no reported blurring of vision or ocular irritation, even at the
time of application.

“Allegro is excited to share our ex-U.S. proof-of-concept data of
ALG-1007 for dry eye disease,” said Vicken Karageozian, M.D., President
and CEO of Allegro Ophthalmics. “These early results suggest that
ALG-1007 improves the signs and symptoms of dry eye, a disease that
affects millions of people globally, with symptoms that include
scratchy, stinging or burning sensations, and pain or redness in the
eye. This frequently blurs vision, reading ability, and produces light
sensitivity in many patients. Allegro has initiated a second and larger
double-masked, vehicle-controlled ex-U.S. Phase 2 clinical trial,
results of which are anticipated in the second half of 2019.”

“This early ex-U.S. proof-of-concept data looks promising, especially at
the higher 0.6% ALG-1007 dose. My fellow Allegro Cornea SAB members* and
I were particularly impressed by how well-tolerated the drug seems to
be,” said Dr. Donnenfeld, founding partner of Ophthalmic Consultants of
Long Island and Ophthalmic Consultants of Connecticut. “Dry eye is a
multifactorial disease and there remain unmet needs for a very large
patient population. It will be interesting to see the outcomes of the
second, larger ex-U.S. study, which is exploring the drug’s efficacy and
safety in even higher concentrations.”

The completed prospective, open-label ex-U.S. proof-of-concept clinical
trial enrolled 40 eyes of 21 patients diagnosed with DED for at least
six months. Patients were assigned to one of four treatment doses (n=10,
each group): 0.125%, 0.25%, 0.4% and 0.6% of ALG-1007 in a lubricating
ophthalmic topical solution. Topical treatment was administered as one
drop two times per day, and subjects were followed at multiple
timepoints for 12 weeks. Outcome measures were tear break-up time
(TBUT), SICCA total ocular staining score, corneal and nasal
conjunctival staining score, and reported symptoms using the visual
analog scale (VAS) symptom index.

*The Allegro Cornea Scientific Advisory Board (SAB) includes Drs.
Richard L. Lindstrom, Edward J. Holland and Eric D. Donnenfeld.

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 anti-integrin therapies for the
treatment of ocular diseases. Allegro’s lead investigational drug
risuteganib (Luminate®) successfully completed two Phase 2 diabetic
macular edema (DME) studies and is currently being evaluated in a U.S.
Phase 2 intermediate dry age-related macular degeneration (intermediate
dry AMD) study. Expanding its anti-integrin portfolio, Allegro has
developed ALG-1007, an anti-integrin drug candidate for topical use in
DED. ALG-1007 has successfully completed an ex-U.S. proof-of-concept
study in humans, and is currently being evaluated in a larger ex-U.S.
Phase 2 study. 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:

1. Donnenfeld E, Holland E, Lindstrom R, Vardanyan A, Adamyan T,
Karageozian L, Aubel J, Sarayba M. A Pilot Study to Evaluate the
Safety and Exploratory Efficacy of ALG-1007 Topical Ophthalmic Solution
for the Treatment of Dry Eye Disease. 2019 ASCRS•ASOA.

Contacts

MEDIA:
Michele Gray
Gray Communications, LLC
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449-9250
[email protected]