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Allegro Ophthalmics Announces Positive Topline Results from DEL MAR Phase 2b Stage 2 Trial Evaluating Luminate® in Patients with Diabetic Macular Edema


DEL MAR Stage 2 Study Meets Primary Endpoint of Vision
Non-Inferiority to Anti-VEGF with 12 Week Durability in a Mostly Chronic
Anti-VEGF DME Population

Allegro Ophthalmics, LLC, a biotechnology company focused on the
development of novel therapies to treat neovascular retinal diseases,
today announced that the DEL MAR Phase 2b Stage 2 clinical trial met its
primary endpoint when used as a sequential therapy in patients with
diabetic macular edema (DME). The study evaluated Luminate®
as a sequential therapy or in combination therapy with anti-VEGF in 80
patients with DME. The 1.0 mg dose of Luminate in sequential therapy
demonstrated visual acuity gains equivalent at all time points to
bevacizumab monotherapy and again showed 12 week durability after the
completion of three loading doses. Results from the DEL MAR Stage 1
trial, in which Luminate met its primary and secondary endpoints as a
monotherapy treatment for DME, were released in October 2016.

The primary endpoint of the DEL MAR Phase 2 Stage 2 study was
non-inferiority to bevacizumab in mean change in best-corrected visual
acuity (BCVA) at 20 weeks when Luminate was used with a single
bevacizumab pre-treatment (sequential therapy) or in combination with
bevacizumab. The Luminate results were achieved after one treatment of
1.25 mg bevacizumab (week 0) followed by three 1.0 mg Luminate
injections (weeks 1, 4, and 8) and 12 weeks off treatment, compared to 5
injections given every 4 weeks with bevacizumab. The data showed the
mean gain in BCVA was 7.1 letters for patients in the Luminate with
bevacizumab pre-treatment (sequential) group compared to 6.7 letters for
patients in the bevacizumab control group.

"Positive results in DEL MAR Stages 1 and 2 continue to confirm
Luminate's safety and efficacy, and its 12-week durability in patients
with DME," said Vicken Karageozian, M.D., President and Chief Medical
Officer, Allegro Ophthalmics. "What's more, about 60 percent of those
treated in the DEL MAR trial had been chronic anti-VEGF users, which
suggests that Luminate, with its unique mechanism of action, may
successfully treat more patients, including those who don't respond to

"These study results are very promising," said David S. Boyer, M.D.,
Clinical Professor of Ophthalmology, USC/Keck School of Medicine;
Founder, Retina Vitreous Associates Medical Group; and, member of
Allegro's Scientific Advisory Board. "Not only could Luminate be used as
an effective monotherapy with fewer injections, but the latest data
suggests that this drug, with its unique mechanism of action, when used
as a sequential therapy with an anti-VEGF agent, may provide physicians
and DME patients with a new treatment paradigm for DME. Used this way,
Luminate with an anti-VEGF pre-treatment could be used to clear VEGF,
decrease VEGF production, and cut inflammation at the same time. This
should be particularly useful for half of the current patient population
that doesn't respond adequately to repeated anti-VEGF treatments alone."

The double masked, placebo-controlled, randomized, multi-center, 5-month
Phase 2b, Stage 2 trial included 5 arms:

  • Luminate 0.5 mg or 1.0 mg as a sequential therapy after a single
    treatment of 1.25 mg bevacizumab (week 0) followed by three Luminate
    injections (weeks 1, 4, and 8), and 12 weeks off treatment
  • Luminate 0.5 mg or 1.0 mg given in direct combination with bevacizumab
    1.25 mg at weeks 1, 4, and 8, and 12 weeks off treatment
  • A 1.25 mg bevacizumab control arm of 5 monthly injections

The trial also found that Luminate was well-tolerated with no drug
toxicity or intraocular inflammation. These safety results are
consistent with previously conducted Luminate studies on human subjects
where there were no reports of significant inflammation, and no evidence
of retinal tears or detachments. The study was conducted at 14 U.S.

About Luminate

Luminate, a first-in-class integrin peptide therapy, treats neovascular
retinal diseases by targeting integrin receptors involved in cell
signaling and regulation and in the construction of new and aberrant
blood vessels. It is the first class of drug for retinal angiogenesis
that shuts off the source of production of growth factors, directly
interferes with vessel construction and has specific anti-inflammatory
properties. Luminate has been shown in clinical studies to effectively
maintain and improve vision by regressing and inhibiting new blood
vessel formation, as well as reducing vascular leakage. Currently in
Phase 2 clinical trials for multiple indications, Luminate is an
investigational drug not approved by the FDA for commercial sale in the
U.S. Allegro maintains commercial rights to Luminate in all territories
outside of Japan, Korea and China.

About Allegro Ophthalmics, LLC

Allegro Ophthalmics, LLC is establishing integrin peptide therapy as the
next-generation pharmaceutical category for the treatment of neovascular
retinal diseases. Allegro's lead investigational drug, Luminate, has
successfully met the endpoints for its first three Phase 2 studies and
has demonstrated the ability to significantly reduce the current burden
of intravitreal injections and treat non-responsive patients with
diabetic macular edema and age-related macular degeneration. By quickly,
safely and cost-effectively bringing to market new and improved
treatment options for leading causes of blindness, Allegro is committed
to offering patients an improved quality of life sustained by
self-sufficient, functional vision. For more information, visit

Luminate® is a registered trademark of Allegro Ophthalmics,

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