`
`Transcript of Robert Noecker, M.D.
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`Date: November 13, 2022
`Case: Slayback Pharma LLC -v- Eye Therapies LLC (PTAB)
`
`Planet Depos
`Phone: 888-433-3767
`Fax: 888-503-3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
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`Slayback Exhibit 1053, Page 1 of 64
`Slayback v. Eye Therapies - IPR2022-00142
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`Transcript of Robert Noecker, M.D.
`November 13, 2022
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` A P P E A R A N C E S
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` ON BEHALF OF THE PETITIONER, SLAYBACK PHARMA
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` LLC:
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` LINNEA P. CIPRIANO, ESQUIRE
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` Goodwin Procter LLP
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` 620 Eighth Avenue
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` New York, New York 10018
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` 212-813-8800
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` lcipriano@goodwinlaw.com
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` ON BEHALF OF THE PATENT OWNER, EYE THERAPIES
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` LLC:
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` CHRISTINA YANG, ESQUIRE
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` BRYAN DINER, ESQUIRE
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` JASON ZHANG, ESQUIRE
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` Finnegan, Henderson, Farabow, Garrett &
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` Dunner LLP
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` 901 New York Avenue NW
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` Washington, District of Columbia 20001-4413
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` ______________________________________
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`---------------------------------X
`
`SLAYBACK PHARMA LLC, :
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` Petitioner, :
` Case No.:
` v. :
` IPR2022-00142
`EYE THERAPIES LLC :
` U.S. Patent No.
` Patent Owner :
` 8,293,742
`---------------------------------X
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`
`
` Deposition of Dr. Robert Noecker
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` Norwalk, Connecticut
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` Sunday, November 13, 2022
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` 9:25 a.m.
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`Job No.: 468951
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`Pages 1-122
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`Reported by: Angela (Angie) Shaw-Crockett, CRR, RMR
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`ALSO PRESENT:
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` Rocco Mercurio, The Videographer
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` I N D E X
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` Examination of: Page
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`Dr. Robert Noecker
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` C O N T E N T S
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`MS. CIPRIANO 6
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`MR. DINER 118
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`DEPOSITION EXHIBIT PAGE
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` Deposition of Dr. Robert Noecker, held at:
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` Norwalk, Connecticut 06845
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` Pursuant to Notice, before Angela (Angie)
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`Exhibit 1046 Figure 2 of '742 patent 80
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`Shaw-Crockett, CRR, RMR, Notary Public in and for the
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`states of New York, New Jersey and Connecticut.
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`PLANET DEPOS
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`Slayback Exhibit 1053, Page 2 of 64
`Slayback v. Eye Therapies - IPR2022-00142
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`

`

`Transcript of Robert Noecker, M.D.
`November 13, 2022
`5
` THE VIDEOGRAPHER: We are now going on the
`record. Today is November 13, 2022, and the time is
`approximately 9:25.
` This is media 1 of the video deposition of
`Dr. Robert Noecker in the matter of Slayback Pharma
`LLC v. Eye Therapies LLC, filed in the U.S. Patent and
`Trademark Office, case number IPR2022-00142.
` My name is Rocco Mercurio, and the court
`reporter is Angie Shaw-Crockett, and we're with Planet
`Depos.
` Would counsel please introduce yourselves
`and who you represent for the record.
` MS. CIPRIANO: My name is Linnea Cipriano
`of Goodwin, representing Petitioner.
` MR. DINER: My name is Bryan Diner of the
`Finnegan firm, representing the patent owner, with my
`colleagues Christina Yang and Jason Zhang.
` THE VIDEOGRAPHER: The court reporter will
`now swear in the witness, and we can now proceed.
` Dr. Robert Noecker, having been duly sworn, testified
`as follows:
`EXAMINATION
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` A It was for Combigan.
` Q And was this the only time you served as an
`expert witness in a patent case?
` A No.
` Q How many other times?
` A About six.
` Q Have you always represented the patent
`owner in those proceedings?
` A I've -- you know, these things come to
`different levels. So it's -- sometimes it's --
`it's -- I've had all-different-level discussions with
`defendants, plaintiffs, two branded product against
`each other.
` Q So this will probably proceed as your other
`depositions, but I'd like to go over some ground rules
`to make sure we're on the same page.
` I'll be asking you questions, and you'll be
`answering them today. Your answers will be -- you've
`just been put under oath. You understand that your
`answers are as if you were testifying in court.
` Do you understand that?
` A Yes.
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` Q During the course of the deposition, your
`counsel may make objections, but unless you've been
`instructed by your counsel not to answer, I will
`expect you to answer my questions.
` Do you understand that?
` A Yes.
` Q As you know, we have a court reporter here,
`taking down everything we say. That means that you
`and I both must make an effort to speak slowly and
`clearly. And I'll try not to speak over you if you
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`try not to speak over me.
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` Do you understand?
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` A Yes.
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` Q We'll be taking breaks from time to time,
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`and if you can please let me know if you need a break
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`at any point. I'll just ask that we finish a question
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`and answer before we take a break.
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` Does that make sense?
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` A Yes.
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` Q Can you -- I will ask you today to listen
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`carefully to my questions, and if there's something
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`that you don't understand, please let me know. I'm
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`BY MS. CIPRIANO:
` Q Good morning.
` A Good morning.
` Q Would you please state your name for the
`record?
` A Robert Noecker.
` Q Have you been deposed before?
` A Yes.
` Q How many times?
` A Eight, ten.
` Q Okay. And what was the most recent time?
` A The most recent time was in conjunction
`with a medicolegal thing.
` Q Okay. How long ago was that?
` A A year ago. During COVID.
` Q Okay. Have you ever served as an expert
`witness in a patent case before?
` A Yes.
` Q And when was that?
` A The last one was two years ago.
` Q And what product -- at a high level, what
`product was that involved with?
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`Slayback Exhibit 1053, Page 3 of 64
`Slayback v. Eye Therapies - IPR2022-00142
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`

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`Transcript of Robert Noecker, M.D.
`November 13, 2022
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`looked at in preparation for the deposition?
` A None specifically. Most that are related
`to the expert report.
` Q I'm going to hand you a copy of your
`declaration, which is marked Exhibit 2020 in the IPR.
` Do you recognize this as being the
`declaration that you submitted in IPR2022-00142.
` A Yes, it appears to be.
` Q And at a high level, how did you prepare
`your declaration?
` A Basically, read the issues at hand in the
`case, reviewed the literature, started composing the
`document, met, at times, with the attorneys to fill in
`the blanks, edited extensively.
` Q Did you review any of the declarations from
`the other experts in this case?
` A Yes.
` Q At what point did you review those in your
`preparation?
` A At some point in the last year.
` Q Before you signed your declaration?
` A I believe so. The time is a little vague
`
`sure that I will not be as clear as I intend to be at
`times during the day. But if you do answer my
`question, I'll assume that you understood the
`question.
` Does that make sense?
` A Yes.
` Q And you understand that while I'm asking
`you questions today, you're not to permitted to
`discuss the substance of your testimony with your
`counsel.
` Do you understand that?
` A Yes.
` Q Is there any reason that you will not be
`able to answer my questions fully and truthfully
`today?
` A No.
` Q Did you prepare for today's deposition?
` A Yes.
` Q So without revealing any privileged
`communications with your counsel, at a high level,
`what did you do to prepare for today's deposition?
` A I read my expert report multiple times, and
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`at this point.
`related materials, and met with the attorneys.
` Q Are there any corrections or changes you'd
` Q With whom did you speak concerning this
`like to make to this declaration at this point?
`deposition?
` A No.
` MR. DINER: Vague.
` A What do you mean by that?
` Q You're currently employed, correct?
` A That's correct.
`BY MS. CIPRIANO:
` Q What is to your current title?
` Q Who did you talk to in preparation for the
` A I'm an ophthalmologist with Ophthalmic
`deposition?
`Consultants of Connecticut.
` A So in preparation, I met with the three
`attorneys here.
` Q And you understand you're being presented
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`as an expert in this proceeding, correct?
` Q Anyone else?
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` A That's correct.
` A No.
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` Q What is your area of expertise?
` Q Have you had conversations with any of the
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` A It's treatment of conditions of the --
`other people who submitted declarations in this IPR?
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`diagnosis and treatment of conditions of the eye.
` A No.
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` Q And you're not a chemist, right?
` Q Did you review any documents other than
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` A I'm not a chemist myself.
`your expert declaration to prepare for this
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` Q You're not an expert in the formulation of
`deposition?
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` A Well, as I always do, I review my own
`eye drops?
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` A I'm familiar and I've done formulation
`personal experiences as well as the relevant
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`work, but I'm not an expert.
`literature.
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` Q What do you mean by "done formulation
` Q Do you recall any specific documents you
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`Slayback Exhibit 1053, Page 4 of 64
`Slayback v. Eye Therapies - IPR2022-00142
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`

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`Transcript of Robert Noecker, M.D.
`November 13, 2022
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`work"?
` A I've performed research in which we need to
`formulate compounds.
` Q Have you ever manufactured a formulation of
`an eye drop?
` A I have not.
` Q Have you ever been involved in determining
`which excipients will be used in the formulation of an
`eye drop?
` A For experimental purposes, not for
`commercial purposes.
` Q And when was that?
` A Several years ago at the
`University of Arizona.
` Q And what product was that for?
` A We were -- well, several glaucoma
`medications.
` Q What drugs?
` A One called "latanoprost," another one
`called "latanoprost 1," another one for some
`antibiotics.
` Q And what was your role in?
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`so just so we're on the same page.
` You are not an expert in commercial
`marketing, correct?
` A That's correct.
` Q So throughout your declaration, you make
`statements that refer to what you understand other
`experts or declarants in this proceeding will say.
` Do you recall that?
` A Yes.
` Q And when you make those statements, you're
`not offering independent opinions on what those other
`experts said, correct?
` A Correct.
` Q So you're relying on the expertise of
`others?
` A That's correct.
` Q I'd like to turn now to some vocabulary to
`make sure that we're speaking the same language.
` So let's turn to page 14 of your
`declaration.
` A (Witness complies.)
` Q Are you there?
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` A Yes.
` A We were doing experiments, so we were
`basically developing these drugs to look at stability
` Q Okay. And here you have a diagram of two
`and things like that.
`pictures of the eye, right?
` A Yes.
` Q And your input was on the clinical side?
` A Well, some of these are rabbit studies, so
` Q And the bottom diagram, it's a
`I was the guy who did stuff to the rabbits.
`cross-section, and the front of the eye is facing
`Depended -- yeah, I was basically the clinical
`left, correct?
` A Yes.
`advisor, had to put things in clinical perspective.
` Q And that front section is called the
` Q You're not an economist, right?
` A I am not.
`"anterior portion" of the eye, correct?
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` MR. DINER: Objection, vague.
` Q And you're not an expert in commercial
`11
` A You have to be more specific.
`marketing, correct?
`12
`BY MS. CIPRIANO:
` THE VIDEOGRAPHER: Hold on. Your mic just
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` Q Okay. Can you explain to me what's
`went out.
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`referred to as the anterior portion of the eye?
` We're now going off the record. The time
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` A Well, it will depend on the context, but we
`is now 9:35.
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`frequently refer to the "anterior chamber," so talking
` (Recess.)
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`about the inside of the eye, the anterior chamber is
` THE VIDEOGRAPHER: Now going back on the
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`divided from the post chamber -- in the side view,
`record. The time is 9:44.
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`we're speaking.
`BY MS. CIPRIANO:
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` So everything kind of from the iris, the
` Q I might repeat some of the questions. I'm
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`colored part, forward, to the front -- toward the
`not sure we got all of the answers to my last round,
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`Slayback Exhibit 1053, Page 5 of 64
`Slayback v. Eye Therapies - IPR2022-00142
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`Transcript of Robert Noecker, M.D.
`November 13, 2022
`17
`front of the eye is anterior chamber. Everything
`behind the iris is the posterior chamber.
` Q So the lens is in the posterior chamber; am
`I understanding?
` A That's correct.
` Q Okay. You also have a diagram on page 16
`of your declaration. And I'd like to take a look at
`what's labeled "sclera" in this figure.
` So the sclera label points to two different
`things.
` Do you see that?
` A Yes.
` Q One is pointing to the front picture of the
`eye. And that's pointing to the white that surrounds
`the iris, right?
` A The sclera is dense connective tissue
`that's kind of the back -- it's 80 percent of the eye.
`The outside of the shell of the eye is the way to
`think about it.
` Q And what you can see of the sclera in the
`picture of the front of a person's eye is the white
`part, correct?
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`part.
` Q Okay. So the sclera -- just so I
`understand this correctly, the sclera is what's
`pointed to in that -- in the blue triangle, if you
`will, that includes the episclera, stroma, lamina
`fusca, and endothelium?
` A In that cross-section.
` Q Okay. You agree that the blood vessels
`that cause eye redness are the blood vessels that
`reside in the sclera, correct?
` MR. DINER: Objection, vague.
` A No. I disagree with that.
`BY MS. CIPRIANO:
` Q Where are the blood vessels that cause eye
`redness?
` A If we're talking about eye redness as
`relevant to this case, so we're talking about
`hyperemia mostly, predominantly, those are
`conjunctival blood vessels.
` Q And they're not in the sclera?
` MR. DINER: Objection. Mischaracterizes
`testimony.
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` A They are not in the sclera.
` A The sclera is all white; it's collagen.
`BY MS. CIPRIANO:
` Q Maybe we're speaking past each other.
` Q In relation to the sclera, where is the --
` Where it points to -- where sclera points
`where are the conjunctival blood vessels?
`to a section of the person's eye that you can see the
` A They're in the conjunctiva.
`brown eye with the eyelashes and the eyebrow, there,
` Q And where is that in relation to the
`the arrow is pointing to the white space around the
`sclera?
`iris, correct?
` A It's superficial, in part, to the eye.
` A Yeah. That -- that's part of it.
`It's superficial in the portion.
` Q Okay. And the other line from the word
` Q Okay. And superficial meaning it's on top
`"sclera" goes to a box that's near the back of the eye
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`of the episclera?
`in the bottom diagram, correct?
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` A Correct.
` A It's a cross-section, yes.
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` Q Prior to Lumify, there were a number of
` Q And that's because the sclera, as you said,
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`over-the-counter eye redness reducers on the
`surrounds the entire part of the eye, not just the
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`commercial market.
`part of the eye you can see, correct?
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` A It's the back. It's approximately
` You agree with that, right?
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` A Yes.
`80 percent of the shell, the outside of the eye,
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`the -- it provides structural support to the eye.
` Q So if we could turn to page 25 of your
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`declaration --
` Q So that square that the sclera line points
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` A (Witness complies.)
`to is then magnified in a cross -- further
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` Q -- just for reference.
`cross-section on the left of that diagram?
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` A It's a cross-section of the sclera in that
` You list a few in the chart that's at the
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`Slayback Exhibit 1053, Page 6 of 64
`Slayback v. Eye Therapies - IPR2022-00142
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`Transcript of Robert Noecker, M.D.
`November 13, 2022
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`bottom of that page. And some examples that you list
`are Naphcon, Naphcon-A, All Clear, Ocu-Clear, Visine,
`and Visine Advanced Redness Relief.
` Do you see that?
` A Yes.
` Q And these were all FDA approved as
`over-the-counter treatments, correct?
` A Yes.
` Q So you'd agree that all of these were
`considered by the FDA to be particularly safe,
`correct?
` MR. DINER: Objection, vague. Lacks
`foundation.
` A I'd have to look at that closer -- what the
`FDA said.
`BY MS. CIPRIANO:
` Q Well, let's look at what you said in
`paragraph 61 of your declaration.
` In -- starting four lines down, you say
`"Because OTC products treat self-diagnoseable
`conditions without a health care provider's
`instructions, they are susceptible to misuse through
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`recognize these products are certainly not perfect.
`And frequently, there's many patients sometimes we
`recommend that they don't use these products.
` So it depends on the context, depends on
`the clinical scenario, what we say is particularly
`safe or not.
`BY MS. CIPRIANO:
` Q When you say these products are not --
`certainly not perfect, you'd agree that all of these
`products had side effects like hyperemia,
`conjunctivitis, and medicamentosa?
` A Those are possible. Don't happen every
`time, but they're possible, yes.
` Q You agree some people misused or overused
`over-the-counter redness relievers, correct?
` A I mean, generally, I think any therapy
`people -- somebody, some person, has probably overused
`or improperly used. We see that all the time.
` Q And you agree that some people had to stop
`using prior over-the-counter redness relievers because
`either of the side effects or because they stopped
`working, correct?
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`overuse. Therefore, they must not only be
` MR. DINER: Objection. Incomplete
`efficacious, but they must also be particularly safe."
`hypothetical. Lacks foundation.
` Do you see that?
` A For any specific, there's always a possible
` A I do.
`scenario where that's true. And I think there's
` Q So you'd agree that if a product is
`certainly individual anecdotal cases where that's
`approved to be over-the-counter, it must be
`happened with, once again, these products and every
`particularly safe?
`other product that's ever been used to treat a human.
` A Yeah. The context of that -- of that
`BY MS. CIPRIANO:
`phrase, or the sentence is -- is always -- in
` Q Let's talk a little bit about brimonidine.
`medicine, we always take this risk-benefit position.
` You'd agree that brimonidine is known to
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`So the more bad your condition is or more serious,
`have ocular hypertensive effects, correct?
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`say, in our field, glaucoma blinds you, so we'll
` A We primarily use brimonidine to lower eye
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`accept more risk.
`pressure.
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` Q Okay. But for redness reducers that are --
` Q And when you say "lowering eye pressure,"
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`were commercially available as over-the-counter
`that's lowering the intraocular pressure, correct?
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`products, you'd agree that the products that are
` A That's correct.
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`listed in the charts on page 25 of your declaration --
` Q And when we say "intraocular pressure,"
`17
`that those products were deemed to be particularly
`that's the fluid inside what -- I think what we
`18
`safe, correct?
`referred to as the posterior segment of the eye?
`19
` MR. DINER: Objection. Mischaracterizes
` MR. DINER: Objection, vague.
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`his testimony. Lack of foundation.
` A I don't exactly understand what you said
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` A No. I mean, these -- and we certainly
`that last time.
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`Transcript of Robert Noecker, M.D.
`November 13, 2022
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`BY MS. CIPRIANO:
` Q Okay. So when we talk about lowering
`intraocular pressure, the pressure that we're talking
`about is the pressure of the fluid that's inside the
`eye, correct?
` MR. DINER: Objection, vague.
` A Well, intraocular pressure is the pressure
`inside the eye.
`BY MS. CIPRIANO:
` Q And what is causing that pressure?
` Let me rephrase that.
` What is exerting the pressure in the eye?
` A Well, the eye always has a pressure. And
`so there's this fluid aqueous which the eye makes and
`drains it away.
` Q And what I'm trying to get at is where that
`fluid is held in the eye.
` And is that in the -- if we need to go back
`to the picture, maybe that would be helpful.
` Is that in the section of the eye that's
`behind the lens?
` A Well, it circulates around the eye.
`
`7 (25 to 28)
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`BY MS. CIPRIANO:
` Q Yeah, let's step back.
` What I'm trying to understand is, there
`are -- "hypotensive" can have a couple of different
`meanings in medicine. It's referred to a couple of
`different ways.
` There are agents that are characterized, at
`least in my understanding of the literature, as
`hypotensive agents that are administered to reduce a
`patient's blood pressure.
` You agree with that?
` A Yes, there's some agents we use to reduce
`blood pressure, yes.
` Q Okay. But when you say that brimonidine is
`known to have hypotensive effects, that's limited to
`the fact that it's known to have ocular hypotensive
`effects, correct?
` MR. DINER: Objection. Mischaracterizes
`the document.
` A It depends on the root of administration.
`BY MS. CIPRIANO:
` Q And what do you mean by that?
`
`26
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` Q It's everywhere in the eye?
` A It's -- it's moving.
` Q Okay. So intraocular pressure is not the
`same as blood pressure, right?
` A Correct.
` Q So brimonidine hasn't ever been used to
`reduce systemic blood pressure, right?
` A I don't know if it's been attempted.
` Q You're not aware?
` A I'm not aware.
` Q Okay. But you agree it's not known to be a
`systemic hypotensive agent, right?
` A On average -- once again, it depends how
`you administer it.
` Q I'm not sure I understand.
` A How are -- the question is, how are you
`administering it?
` Q Systemically?
` A Systemically.
` MR. DINER: Objection, vague.
` A So you're saying to give it to a person,
`like, intravenously or --
`
` A How are you giving it to the person?
` Q Is it your opinion that a person of
`ordinary skill in the art would understand that
`brimonidine was known prior to 2008 to have systemic
`hypotensive effects?
` A Brimonidine? Depending how you administer,
`it could.
` Q Are you aware of any study published prior
`to August of 2008 that showed brimonidine to be a
`vasodilator in the anterior portion of the eye?
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` A I'm not sure exactly what -- those terms
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`aren't as specific as I'd like, but I think there's
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`certainly, from our clinical studies we've seen, blood
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`vessels on the surface of the eye get quite dilated
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`with the use of brimonidine, yes.
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` Q And in what -- strike that.
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` And what clinical studies are you referring
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`to?
`18
` A So Alphagan eye drop study used for
`19
`glaucoma, we saw significant red eyes or hyperemias
`20
`when used in eye-drop form at 0.2 percent.
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` Q Okay. So you're talking about the adverse
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`Transcript of Robert Noecker, M.D.
`November 13, 2022
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`hypothetical.
` A I think what you're asking me is, can
`these -- can drugs with alpha 1 properties cause
`hyperemia, which is yes.
`BY MS. CIPRIANO:
` Q So hyperemia is not necessarily a -- strike
`that.
` So hyperemia is not necessarily a sign that
`a drug is a vasodilator, correct?
` A I don't understand the question.
` Q Okay. Let's take it step by step.
` You -- so I asked you whether you were
`aware of any studies showing that brimonidine was a
`vasodilator in the eye when applied topically -- let
`me start over.
` So it's your position that because
`brimonidine causes hyperemia, that it can be a
`vasodilator when applied topically to the eye; is that
`correct?
` A I think what we can say is that when we see
`that the blood vessels on the surface of the eye are
`engorged, they're vasodilators; the blood vessels are
`32
`dilated. If they're red and engorged, hyperemia.
` Q And that same type of hyperemia where when
`the blood vessels of the eye are engorged occurs after
`a topical administration of alpha 1 agonists, correct?
` MR. DINER: Objection. Mischaracterizes
`prior testimony.
` A The answer is, it depends.
`BY MS. CIPRIANO:
` Q But it can?
` A In a very specific scenario, based on the
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`timing when you're measuring these things. If you
`11
`give me a specific clinical scenario, we can address
`12
`whether or not it probably happens.
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` Q So when you say that brimonidine causes
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`hyperemia, what was the timing of measuring that
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`hyperemia?
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` A There are many time points.
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` Q Okay. Let's look at -- we'll look at some
`18
`specific studies a little bit later, maybe to get to
`19
`the bottom of that.
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` So we talked a little bit about the
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`Alphagan product. You mentioned that.
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`event of hyperemia that is seen after administration
`with brimonidine, correct?
` MR. DINER: Objection to the extent it
`mischaracterizes testimony.
` A The -- well, it was 0.2 percent Alphagan
`used. It was a glaucoma study, and that was one of
`the endpoints that were measured.
`BY MS. CIPRIANO:
` Q What was an endpoint?
` A Eye redness, hyperemia.
` Q And what study is this?
` A 1996. I'm trying to think of the first
`author.
` I can look it up. I can't remember off the
`top of my head the author. But it was the
`FDA-approval studies, the phase III trials submitted
`for approval of Alphagan, that hyperemia was recorded
`in that.
` Q Do they measure redness?
` A I'm sorry. What do you mean by "measure"?
` Q Did -- was there a scale that was recorded
`that measured redness in those studies?
`
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` A In that study, I'm not sure if there was a
`scale, no.
` Q So when you say recorded "redness," they
`recorded whether hyperemia was observed, correct?
` A I'd have to go back and look at the study
`protocol, which we did. I'm not sure if there was a
`grading scale. I can't remember.
` Q To go back to my question about studies
`showing brimonidine to be a vasodilator.
` You agree that even -- well, strike that.
` Let me back up a little bit.
` You'd agree that alpha 1 agonist drugs are
`accepted to be vasoconstrictors in the eye, correct?
` A So I'll -- so to answer that, I'll assume
`that you're -- that topically administrated [sic] in
`the form of an eye drop that, applied to the eye, that
`you can have -- you'll have a vasoconstrictive effect
`on the surface blood vessels of the eye, yes.
` Q And those same alpha 1 agonist drugs that
`are applied topically in the form of an eye drop also
`can cause hyperemia, correct?
` MR. DINER: Objection. Incomplete
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`Transcript of Robert Noecker, M.D.
`November 13, 2022
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` A I did mention that, yes.
` Q And Alphagan, I understand, was available
`in concentrations of 0.5 percent brimonidine and
`0.2 percent brimonidine; is that correct?
` A What do you mean by "available"?
` Q It was marketed in those strengths.
` A It was never marketed in 0.5 percent.
` Q Okay. So original Alphagan was marketed at
`0.2 percent?
` A That was the original Alphagan, yes.
` Q And another product called "Alphagan P" was
`also marketed in that family, correct?
` A That's correct.
` Q And that was available, commercially
`available, at 0.15 percent and 0.1 percent?
` A Yes.
` Q And those Alphagan and Alphagan P were both
`Alphagan products, correct?
` A Yes.
` Q And Alphagan concluded that all -- that the
`Alphagan and Alphagan P products were safe and
`comfortable for patients, correct?
`
`9 (33 to 36)
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`35
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`clinical studies that were part of the NDA.
` Do you see that?
` A Yes.
` Q Okay. And then on page 13, this is, if you
`will, an expanded chart, providing a little more
`information about the clinical studies that were
`listed in on page 12; is that correct?
` A Yes.
` Q And the clinical studies listed on page 13
`are categorized as "early dose tolerance studies."
` Do you see that?
` A Yes.
` Q Okay. And then on the right-hand side,
`there's a "study conclusions" column.
` Do you see that?
` A Yes.
` Q And for all of these studies, Alphagan
`represented to the FDA that brimonidine, at all the
`concentrations tested, was safe and comfortable,
`right?
` MR. DINER: Objection, foundation.
` Dr. Noecker, it is a large document. You
`
` MR. DINER: Objection. No foundation.
` A What's the context of that statement?
`BY MS. CIPRIANO:
` Q Do you disagree?
` MR. DINER: Same objection. No foundation.
` A I mean, they're approved by the FDA.
`BY MS. CIPRIANO: