Full Press Release Details
EyeGate Pharmaceuticals,
SECTOR - PHARMACEUTICALS
(AZC611) TWST: Could you provide a brief
overview of the company and also talk about why it was now that you've decided to go public?
From: EyeGate Pharmaceuticals focuses on the ophthalmic area, and what we actually have is a platform technology based on iontophoresis
that allows us to deliver drugs to the front or back of the eye noninvasively. We have one drug that is in the clinic. That is
a corticosteroid with the first indication being for moderate to severe anterior uveitis, and that we are delivering through the
platform. There will be others in the near future. Related to anterior uveitis, which is at the front of the eye, we just initiated
a small pilot study using the same combination of drug and device for treating the back-of-the-eye disease called macular edema.
It just got underway recently.
actually looked to go public not too long ago. We ended up doing a small round and did an OTC listing five months ago. Within the
last five months, we have accomplished some pretty important milestones. Off the back of those milestones earlier this month, we
closed a bigger fundraise and uplisted to Nasdaq.
by hitting some of those milestones, you were in need of more capital. Can you talk about what some of those milestones were?
From: Yes. Our first indication is for the front of the eye. There are only three players that have a sales force right now
in the U.S. that cover that space, and those are Alcon, Allergan and Valeant Pharmaceuticals. We were able to announce on July
10 a licensing agreement for our lead product for uveitis with Valeant Pharmaceuticals. It was a huge milestone for us to get done.
It is really difficult
to get drug into the eye. There are only two modalities that have been approved by the FDA, and those are either an eye drop or
an injection, and they both have problems. Even at the front of the eye, if you have a more severe condition going on, it can be
difficult to treat properly with just drops. Our device tries to overcome all of that.
There are a lot of companies
like EyeGate working on mousetraps to figure out better ways to accommodate delivery of drug into the eye, whether it be the front
or back. The great thing
for us and what is really important about this
milestone is that we're the first and only to build a mousetrap for which we have a licensing deal done with one of the major
three players. That is saying something. Our platform and technology is the first and only one so far to have that.
TWST: With eye drops,
the limitation is primarily that the dosing is often incorrect, and obviously, with injection, the main limitation would be that
it's just uncomfortable to have a needle go directly into the eye. Am I encapsulating these limitations correctly?
From: Yes. A drop is really inefficient. Only about 5% to 8% of the drug in a drop gets into the tissue. The surface of the
eye is very good at keeping things out, and then, there is the fact that one blinks. Whatever penetrates in that time period between
blinks is all that gets into the eye. The residency time is really short.
Eye drops can work for
short-term issues such as allergy relief or inflammation relief from cataract surgery. Mild drops are perfect for that. When you
get into the more moderate and severe conditions, drops are so inefficient that you have to take them every 30 to 60 minutes throughout
the day for many days and weeks. If that is not sufficient enough, you end up augmenting that with either systemic drugs or injections
we're talking about the back of the eye, which the only way a drug can be delivered to the back of the eye is with a needle,
an injection is done every four weeks to six weeks for people with macular degeneration or even macular edema. The risk for infection
goes up as you have more frequent injections given. Also, the risk for complications goes up. We are trying to avoid all of these
issues, whether it's the front of the eye or the back of the eye, and we believe our technology can because of the way we
deliver a drug through iontophoresis. Iontophoresis is the procedure by which ions flow diffusively in a medium driven by an applied
we have one of the more unique or better mousetraps is what has allowed us to get a deal done with one of the major three companies.
We're developing a corticosteroid as part of our first product, and Valeant Pharmaceuticals has the largest franchise right
now for corticosteroids in the eye. They make the ideal partner for a
INTERVIEW - E Y E G A T E PHARMACEUTICALS, INC.
company like ours that is developing a corticosteroid.
that we are pretty well on our way
through the clinical-trial process with the first
drug, it's time to start focusing on other drugs
to deliver with our platform. We mentioned
macular degeneration earlier, and that's where
I really would like to take this platform."
TWST: What is the name
of that drug, and when is the earliest it might be commercialized?
Mr. From: The actual
drug itself doesn't have a brand name yet, but it is dexamethasone phosphate.
TWST: It requires FDA approval
From: Yes, it does. We go through a pathway called the 505(b)(2). It is already an approved drug, but we're changing
the route of administration. We still need to complete Phase III clinical studies. We have done all the preclinical work and so
forth. But we don't have to do the full gamut because it's not a new class or compound entity.
TWST: Do you have to
get the delivery part approved as a delivery device?
do. They are used together. The studies we do work for both device and drug, but the drug is the gating item. When we file our
NDA for the approval of the drug, we'll also file for approval of the device at the same time.
When would be the earliest they might be commercialized, and can you talk a bit about the market potential?
are initiating a Phase III clinical trial, which is our second pivotal study, right now. We're looking to have that completely
enrolled toward the end of 2016, and then, we hope to file our NDA soon after that. Theoretically, it could be approved toward
the end of the second half of 2017.
TWST: And the market
potential would be? Can you express that in whatever terms that you have decided are best?
described it publicly in terms of the number of incidences because it is difficult to get the actual dollar value for this indication.
We're talking about noninfectious anterior uveitis. There are less than 200,000 incidences in the U.S. per year. A lot of
these patients are chronic. They have an autoimmune disease and will get an inflammatory flare up triggered in the eye. The idea
is to calm that down as quickly as possible. But sometimes that flare up will happen more than once a year. Each flare up is an
incident. You will have maybe more than one incident per patient. So just under 200,000 incidences per year doesn't mean
we have 200,000 subjects with this disease.
TWST: Is that considered an
From: Funny enough it is, but we are unable to attain that designation because the way the FDA orphan department looks at it.
They start with uveitis, and you have to prove to them that you can only treat a subset. Unfortunately, our device can also treat
the back of the eye, so when you include other types of uveitis like
posterior to the interior and panuveitis,
which we can treat all of, the number goes above 200,000.
of the other indications you're going to pursue?
going after right now is macular edema that entails treatment at the back of the eye.
Macular edema affects how many people?
From: We haven't publicly disclosed that, but it's a much larger indication than uveitis. A lot of the people who
get it are diabetics who have diabetic retinopathy and then have edema associated with that. You also get patients who have what
are called retinal vein occlusions that involve edema at the back of the eye. So macular edema is a much larger indication than
anterior uveitis, and the only way to treat it right now is with an intravitreal injection.
Are most patients elderly?
necessarily. Like I said, most are diabetics. Unlike age-related macular degeneration that would pertain to elderly people, macular
edema is not a retinal vein occlusion, and you do not have to be elderly for that. We're seeing that in younger and younger
TWST: But theoretically,
this system can be used for other indications in the future in addition to the ones you are currently investigating?
correct. Now that we are pretty well on our way through the clinical-trial process with the first drug, it's time to start
focusing on other drugs to deliver with our platform. We mentioned macular degeneration earlier, and that's where I really
would like to take this platform.
TWST: When do you think
might be the earliest that that would be approved?