` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`-------------------------------x
`ARGENTUM PHARMACEUTICALS LLC,
` Petitioner
` v. Case IPR2017-01053
` Patent 8,268,299
`ALCON RESEARCH, LTD.,
` Patent Owner
`-------------------------------x
`
` Deposition of YVONNE M. BUYS, M.D.
` May 14, 2018
` Chicago, Illinois
` 7:54 a.m.
`
`REPORTED BY:
`GREG S. WEILAND, CSR, RMR, CRR
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`800-642-1099
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`David Feldman Worldwide
`A Veritext Company
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`www.veritext.com
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`ALCON 2167
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
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`Page 2
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` Deposition of YVONNE M. BUYS, M.D., called
`by the Patent Owner for examination, taken pursuant
`to the Federal Rules of Civil Procedure for the
`United States Patent and Trademark Office pertaining
`to the taking of depositions, taken before GREG S.
`WEILAND, CSR, RMR, CRR, at the offices of Foley &
`Lardner, 321 North Clark Street, Suite 2800, in the
`City of Chicago, Cook County, Illinois, commencing
`at 7:54 o'clock a.m., on the 14th day of May, 2018.
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`PRESENT:
`
`ON BEHALF OF THE PETITIONER:
` FOLEY & LARDNER, LLP
` 321 North Clark Street
` Suite 2800
` Chicago, Illinois 60654-5313
` (312) 832-4378
` BY: MICHAEL R. HOUSTON, Ph.D.
` mhouston@foley.com
`
`ON BEHALF OF THE PATENT OWNER:
` WILLIAMS & CONNOLLY, LLP
` 725 Twelfth Street, N.W.
` Washington, D.C. 20005
` (202) 434-5208
` (202) 434-5138
` BY: ALEXANDER S. ZOLAN, ESQ.
` azolan@wc.com
` CHRISTOPHER J. MANDERNACH, ESQ.
` cmandernach@wc.com
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` INDEX
`May 14th, 2018
`TESTIMONY OF YVONNE M. BUYS, M.D.
` PAGE
`Examination by Mr. Zolan ...........................7
`Examination by Mr. Houston ........................57
`
` DEPOSITION EXHIBITS
`NUMBER DESCRIPTION PAGE
`Exhibit 1025 (Previously marked) 55
` Article, Travoprost with sofZia®
` preservative system lowered intraocular
` pressure of Japanese normal tension glaucoma
` with minimal side effects, by Mizoue, et al.
`Exhibit 1026 (Previously marked) 14
` Article, Antiglaucoma drugs: The role of
` preservative-free formulations, by Bagnis,
` et al.
`Exhibit 1049 (Previously marked) 20
` Article, Effect of timolol with and without
` preservative on the basal tear turnover in
` glaucoma, by Kuppens, et al.
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` DEPOSITION EXHIBITS (CONTINUED)
`NUMBER DESCRIPTION PAGE
`Exhibit 1091 (Previously marked) 49
` Article, Ocular Surface Tolerability of
` Prostaglandin Analogs in Patients with
` Glaucoma or Ocular Hypertension, by Whitson,
` et al.
`Exhibit 1092 (Previously marked) 8
` Second Declaration of Dr. Yvonne M. Buys,
` M.D.
`Exhibit 2127 (Previously marked) 36
` Transcript, Deposition of Dr. Yvonne M.
` Buys, taken November 20, 2017
`Exhibit 2129 (Previously marked) 9
` Preferred Practice Pattern, Primary
` Open-Angle Glaucoma, American Academy of
` Ophthalmology
`Exhibit 2132 (Previously marked) 23
` Article, Ocular surface disease in patients
` with glaucoma or ocular hypertension treated
` wit either BAK-preserved latanoprost or
` BAK-free travoprost, by Katz, et al.
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` DEPOSITION EXHIBITS (CONTINUED)
`NUMBER DESCRIPTION PAGE
`Exhibit 2133 (Previously marked) 38
` Article, Efficacy, safety, and improved
` tolerability to travoprost BAK-free
` ophthalmic solution compared with prior
` prostaglandin therapy, by Henry, et al.
`Exhibit 2139 (Previously marked) 15
` Article, Allergy to ophthalmic
` preservatives, by Hong and Bielory
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`
` (Witness sworn.)
` YVONNE M. BUYS, M.D.
`after being first duly sworn, testified as follows:
` EXAMINATION
`BY MR. ZOLAN:
` Q. Good morning, Dr. Buys.
` A. Good morning.
` Q. Good to see you again.
` Do you agree that as of September 2006
`chemical preservative agents such as benzalkonium
`chloride were known to be harsh to the eye?
` A. Yes, there was a concern that they could
`cause some irritation. I think "harsh" is a strong
`word, but yes.
` Q. And do you agree that as of September 2006
`chemical preservative agents such as benzalkonium
`chloride were known to cause eye irritation in some
`patients?
` A. Yes.
` Q. Do you agree that as of September 2006 a
`person of ordinary skill in the art would have seen
`the advantage of not using benzalkonium chloride to
`preserve a chronically administered eye drop?
` A. Yes.
` Q. I'm going to hand you what's been marked
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`as Exhibit 1092.
` (Exhibit 1092 was identified.)
`BY MR. ZOLAN:
` Q. And this is a copy of the second
`declaration that you've submitted in this action,
`right?
` A. Okay, yes.
` Q. In Paragraph 4 on Page 4, so the second
`part of Paragraph 4, you have a sentence that
`states, "I will note, however."
` Do you see that?
` A. Yes.
` Q. It goes on to say, "I will note, however,
`that if this declaration fails to address something
`argued by Alcon or Dr. Parrish, that should not be
`taken as an admission that I agree with any such
`arguments raised by Alcon and its experts."
` Do you see that?
` A. Yes, I do.
` Q. So other than the points that you raise in
`this second declaration, do you disagree with any
`other aspects of Dr. Parrish's declaration?
` A. I would need to have much longer time to
`review it to look at every specific aspect of it,
`and I would just like to comment on the ones that we
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`mention.
` Q. So sitting here today you can't think of
`anything else that you disagree with from
`Dr. Parrish's declaration?
` A. I believe that the main points that I
`disagreed with were brought up here, the main
`salient points.
` Q. And do you recall anything that you
`disagreed with that you did not raise in this
`declaration?
` A. From the top of my head I cannot recall.
` Q. I'm going to hand you what's been marked
`as Exhibit 2129.
` (Exhibit 2129 was identified.)
`BY MR. ZOLAN:
` Q. Do you recognize Exhibit 2129?
` A. Yes, I do.
` Q. This is the Preferred Practice Pattern
`published by the American Academy of Ophthalmology
`on primary open-angle glaucoma; is that right?
` A. Correct.
` Q. And if you go to Page P64 of this
`document, under the heading Medical Treatment, do
`you see that?
` A. Yes.
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` Q. And the first sentence there states,
`"Medical therapy is presently the most common
`initial intervention to lower IOP."
` Do you see that?
` A. Yes.
` Q. Do you agree?
` A. Yes.
` Q. And that same statement was true in
`September of 2006, right?
` A. Yes.
` Q. Why is medical therapy the most common
`initial intervention to lower IOP?
` A. Because the other interventions, which
`would be surgery and laser, can have higher side --
`or higher risks associated with them.
` Q. Do you see in the second paragraph below
`Medical Treatment the sentence that states,
`"Prostaglandin analogs are the most frequently
`prescribed initial eye drops for lowering IOP in
`patients with glaucoma because they are most
`efficacious, well-tolerated and instilled once
`daily."
` Do you see that?
` A. Yes.
` Q. And do you agree with that?
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` A. Yes.
` Q. And was the same thing true in September
`of 2006?
` A. Yes.
` Q. Can you go to Page P68, please.
` Do you see the heading Laser
`Trabeculoplasty?
` A. Yes.
` Q. In the first sentence there, it says,
`"Laser trabeculoplasty can be considered an initial
`therapy in selected patients," right?
` A. Yes.
` Q. And it's less common though as an initial
`therapy than medical therapy, right?
` A. Yes.
` Q. And it's used as an initial therapy when
`there are problems with medical therapy?
` A. Not necessarily.
` Q. So that sentence that I just read the
`first part of goes on to say, "can be considered as
`initial therapy in selected patients or an
`alternative for patients at high risk for
`nonadherence to medical therapy who cannot or will
`not use medications reliably due to cost, memory
`problems, difficulty with installation or
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`intolerance to the medication."
` Do you see that?
` A. Yes.
` Q. So that second part of the sentence refers
`to the situations in which the medical therapy for
`some reason it's thought is not going to work for
`that patient, and so then the decision is made to
`instead use laser trabeculoplasty?
` A. It could be, yes.
` Q. Okay. And did the situations in which
`laser trabeculoplasty would be used differ today
`from the situations in which laser trabeculoplasty
`would be used in September of 2006?
` A. No.
` Q. Let's go to P70, please. Under the
`heading Incisional Glaucoma Surgery there's a
`subheading Trabeculectomy.
` Do you see that?
` A. Yes.
` Q. In the first sentence there after the
`semicolon, it states, "It is generally indicated" --
`"it" being trabeculectomy -- "when medications and
`appropriate laser therapy are insufficient to
`control disease and can be considered in selected
`cases as initial therapy."
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` Do you see that?
` A. Yes.
` Q. Do you agree with that statement?
` A. Yes.
` Q. And is that statement -- was that
`statement true in September 2006 as it is today?
` A. Yes, it was. However, on Page 69 you can
`see several large trials that were done prior to
`2006 which did support using initial treatment as
`either laser trabeculoplasty or trabeculectomy as in
`some cases being superior to medical treatment in
`preserving visual fields and optic nerve status and
`also in achieving lower intraocular pressures.
` Q. Several of the studies -- are you looking
`at Table 5?
` A. I'm looking at Table 5, correct.
` Q. And several of the studies in Table 5 were
`conducted prior to the introduction of prostaglandin
`analogs as a medical therapy; is that right?
` A. That's correct.
` Q. Can we agree that as of September 2006
`there were some glaucoma patients or patients with
`elevated intraocular pressure who had symptoms of
`ocular surface disease and who would benefit from an
`eye drop that contained a prostaglandin analog and
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`Page 14
`which also did not contain a traditional chemical
`preservative agent?
` A. They would benefit from that as an option.
`They would benefit from an option of a treatment
`that did not have a preservative agent.
` Q. And you used the word "treatment," but I
`want to be clear that --
` A. With medical treatment being one of those
`options, like a preservative-free prostaglandin
`analog.
` Q. I'm going to hand you what's been marked
`as 1026.
` (Exhibit 1026 was identified.)
`BY MR. ZOLAN:
` Q. Do you recognize Exhibit 1026?
` A. Yes, I do.
` Q. This is a document that Dr. Parrish
`cited -- sorry. Strike that.
` This is a document that you cited in your
`first declaration, right?
` A. Correct.
` Q. And in your first declaration you cited
`this document in support of your statement that
`8 percent of patients have a benzalkonium chloride
`allergy; is that right?
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` A. Correct.
` Q. And that statistic comes from Page 391 of
`this Bagnis paper, right?
` A. Correct.
` Q. And this Bagnis paper relies on another
`paper, Hong and Bielory, for that 8 percent figure;
`is that right?
` A. Correct.
` Q. You've now reviewed that Hong and Bielory
`paper?
` A. Yes.
` Q. You wouldn't characterize its methodology
`as rigorous, would you?
` A. I would need to relook at the paper.
` Q. I'm going to hand you what's been marked
`as Exhibit 2139.
` (Exhibit 2139 was identified.)
`BY MR. ZOLAN:
` Q. And Exhibit 2139 is a copy of the Hong and
`Bielory paper that's cited in the Bagnis paper; is
`that right?
` A. Correct.
` Q. So my question is, you wouldn't
`characterize its methodology as rigorous, would you?
` MR. HOUSTON: Objection, form.
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`Page 16
` THE WITNESS: I don't see in the paper a
`specific subtitle that provides the methodology, so
`I'm not really able to comment on the methodology.
`BY MR. ZOLAN:
` Q. Do you have an understanding of how the
`authors of this paper came up with the statistics
`that they use?
` A. This is a review article, so they looked
`at the literature and then summarized papers from
`the literature to come up with their comments.
` Q. So is it your testimony that this paper
`reviewed the substance of articles in this space and
`reached conclusions based on the substance of those
`papers?
` A. Correct.
` Q. If you look at Table 2, do you see the
`column that's headed OVID search in column 2? It's
`five over from the right.
` A. Yes.
` Q. From the left, sorry.
` A. Yes.
` Q. And there's a little "a" at the end of
`that heading, right?
` A. Yes.
` Q. And the little "a" has a footnote down to
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`Page 17
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`the bottom of the table.
` Do you see that?
` A. Yes.
` Q. And the footnote says, "The number of
`results from an OVID or PubMed search for the
`specific type of preservative," and then in
`parenthesis, "e.g., BAC, chlorhexidine,
`chlorobutanol, et cetera," end paren, "is shown in
`the table."
` And then it's got another sentence that
`states, "The number in parenthesis represents the
`number of search items that result from combining
`the specific preservative with the terms
`'ophthalmology' and 'preservative,' for example," in
`parenthesis, "chlorhexidine and preservative and
`ophthalmology."
` Do you see that?
` A. Yes, I do.
` Q. So for the top line in Table 2, Quaternary
`ammonium, do you see that?
` A. Yes.
` Q. The number that's reflected in the OVID
`search is a number of papers that hit upon the
`search terms "BAC" and "preservative" and
`"ophthalmology"; is that right?
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`Page 18
` A. The number in parenthesis, correct.
` Q. And one column over to the right of there,
`there's a further search term that's added to that
`string; is that right?
` A. I don't believe that's added to the
`string. It's added to combining the preservative
`with other terms, including irritant, inflammatory
`or allergic.
` Q. Okay. So if we focus on irritant there,
`in that column --
` A. Yes.
` Q. -- it's irritant and there's a 40 there
`and it says 8 percent.
` Do you see that?
` A. Yes.
` Q. Okay. So that 8 percent figure, correct
`me if you have a different understanding, reflects
`that 8 percent of the 593 from the column directly
`to the left, 8 percent of those search results also
`contained the term "irritant"?
` A. Correct.
` Q. And so if the paper had said BAC is a
`preservative used in ophthalmology and is not an
`irritant, that would have hit on these search terms,
`right?
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`Page 19
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` A. Yes.
` Q. And it would fall within the 8 percent
`figure there?
` A. Yes.
` Q. And that's the 8 percent that's used in
`the Bagnis reference, right?
` A. Yes.
` Q. So if that is the methodology of this
`paper, that's how they reach the conclusion that --
`strike that.
` If Bagnis is relying on this paper for the
`proposition that 8 percent of patients have an
`allergy to BAK, is that a fair conclusion for Bagnis
`to draw from this Hong and Bielory paper based on
`the methodology that we just reviewed?
` A. Probably not. However, this paper then
`goes on to say on the first page that the salts of
`benzalkonium have been classified as being
`moderately allergic by using a skin test, which
`would be a more robust way of checking for an
`IgE-mediated allergic response; and then they quote
`a figure there of 4 to 11 percent with skin testing.
` Q. Right. And those are not the percentages
`that Bagnis relies upon; is that right?
` A. That's correct.
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`Page 20
` Q. And those are not the percentages that you
`relied upon in your first declaration; is that
`right?
` A. That's correct.
` Q. And you don't have any idea where the 4 to
`11 percent statistic comes from, do you?
` A. They do not reference it in this paper.
` Q. You don't have your patients skin tested
`when you're concerned that they're allergic to
`benzalkonium chloride, do you?
` A. No, I do not.
` Q. I'm going to hand you what's been marked
`as Exhibit 1092 -- oh, I've already given you 1092.
` Let's look at Paragraph 14 there, and on
`Page 10 you begin talking about preservative-free
`timolol; is that right?
` A. Correct.
` Q. Timolol is not a prostaglandin analog,
`right?
` A. It is not.
` (Exhibit 1049 was identified.)
`BY MR. ZOLAN:
` Q. I'm going to hand you what is marked as
`Exhibit 1049.
` And do you recognize this document?
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`David Feldman Worldwide
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`Page 21
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` A. Yes, I do.
` Q. This is an exhibit that you rely upon in
`your second declaration, right?
` A. Yes.
` Q. And it's a paper that analyzes the effects
`of timolol with benzalkonium chloride and timolol
`without benzalkonium chloride?
` A. Correct. It was to show the example that
`this was available prior to 2006.
` Q. Right. And if you look at the conclusion
`in the Abstract there on the first page of
`Exhibit 1049, the first sentence of the conclusion
`states, "Preservative-free timolol solution has a
`favorable effect on the tear turnover of patients
`with glaucoma and ocular hypertension in comparison
`to timolol containing BAC."
` Do you see that?
` A. Yes.
` Q. So this paper is concluding that for
`timolol, patients who have glaucoma, the timolol
`without benzalkonium chloride is less harsh on their
`eye than the patients who are taking -- strike that.
` This paper is concluding that for patients
`taking timolol, timolol without benzalkonium
`chloride is less harsh on their eye than timolol
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`Page 22
`
`with benzalkonium chloride. Is that fair?
` A. I don't think so because the actual study
`was measuring tear breakup time, and they couldn't
`find a statistically significant difference in the
`tear breakup time between the timolol with versus
`without benzalkonium chloride. So there was a
`suggestion but no proof.
` Q. Timolol without benzalkonium chloride is
`packaged as a unit dose medication; is that right?
` A. Correct.
` Q. And unit dose medications are not as
`desirable as multidose medications, is that fair?
` A. No, not necessarily because unit dose
`allows you not to have a preservative, which is
`desirable.
` Q. What are the advantages of multiuse
`medications over single unit dose medications?
` A. To have one container that has multiple
`drops is easier than having one container for each
`drop for the patient.
` Q. Are there any other advantages other than
`ease of use?
` A. I think it's really just ease of use.
` Q. How does expense differ between multidose
`packaging and single dose packaging?
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`Page 23
` A. I think it really depends where the person
`is living how the medications are marketed by the
`pharmaceutical companies.
` Q. When you're using a unit dose packaging of
`a medication to treat elevated intraocular pressure
`and the patient opens the packaging and puts a drop
`in their eye, is there any liquid left in the unit
`dose package?
` A. Yes, there should be.
` Q. So there's some waste that's associated
`with unit dose packaging?
` A. I'm not sure if you would necessarily call
`it wastage. I think it's a requirement in order for
`the drop to be able to dispense. And also because
`some patients may not be accurate on their first
`installation, that gives them a little bit extra
`that they could immediately apply another drop if
`they missed, the same as in multiuse bottles though
`too, that you wouldn't expect -- a multiuse bottle
`should only be used for about a month, and there
`should be some left in it at the end of the month.
` Q. I'm going to hand you what's been marked
`as Exhibit 2132.
` (Exhibit 2132 was identified.)
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`David Feldman Worldwide
`A Veritext Company
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`www.veritext.com
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`Page 24
`
`BY MR. ZOLAN:
` Q. Exhibit 2132 is a paper by Katz; is that
`right?
` A. Correct.
` Q. And this is a paper that Dr. Parrish
`relied upon in his declaration?
` A. Yes.
` Q. And it's a paper that you criticize
`Dr. Parrish for relying upon, is that fair?
` A. I criticize the paper.
` Q. That's fair enough. On Page 1253 of this
`Katz article, in the second sentence in the
`Introduction, it states that, "Chronic exposure to
`BAK-preserved IOP-lowering medications has been
`associated with increased frequency of
`patient-reported symptoms of ocular discomfort,
`including burning, stinging, foreign body sensation
`and dry eye sensation."
` Do you see that?
` A. Yes, I do.
` Q. Do you agree with that statement?
` A. Yes.
` Q. And on Page 1254 of the same document, in
`that first carryover paragraph about five lines down
`there's a sentence that begins "In humans."
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`Page 25
`
` Do you see that?
` A. Yes.
` Q. And the sentence states, "In humans,
`chronic exposure to BAK-preserved topical
`IOP-lowering medications was associated with signs
`of adverse effects on the ocular surface, including
`instability of the tear film, reduced density of
`superficial epithelial cells, disruption of corneal
`epithelial barrier function and conjunctival
`inflammation."
` Do you see that?
` A. Yes.
` Q. Do you agree with that statement?
` A. Yes.
` Q. And then in the Results section of this
`paper starting on Page 1256, the first sentence of
`the Results section states, "For the patients who
`had mild OSD at baseline, the mean OSDI score" --
` A. Sorry, you said this was on the first part
`of the Results? I'm looking at Baseline clinical
`and demographic. You're going to the second?
` Q. Sorry. I'm in the Results section on
`Page 1256 directly under the heading Mean change in
`OSDI scores.
` A. Yes.
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`Page 26
` Q. And let me start that sentence over. "For
`the patients who have mild OSD at baseline, the mean
`OSDI score at the 12-week time point was
`significantly lower," and then in parenthesis "P
`equals 0.04," end paren, "in patients randomized to
`BAK-free travoprost 0.004 percent," and then in
`parenthesis, "11.6 plus or minus 10.8 units," end
`paren, "than in patients who continued on
`BAK-preserved latanoprost 0.005 percent," in
`parenthesis, "14.4 plus or minus 11.9 units," end
`paren, "as shown in Figure 2."
` Do you see that?
` A. Yes, I do.
` Q. You don't quote that result in your
`declaration, right?
` A. I am not sure if we mentioned that
`specific result, but that -- what I was quoting in
`the declaration was the main purpose of this study
`was to look at the average OSDI scores for the
`entire population, and then they did several
`subanalyses; and I think there's close to 20
`comparisons in this paper, of which only 2 were
`favorable to show that BAK was -- to show that not
`using BAK or not having BAK in the medication was
`associated with a better result, whereas the
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`A Veritext Company
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`Page 27
`majority of outcomes studied in this paper did not
`find any difference between Travatan, travoprost
`with or without BAK.
` Q. So --
` A. This is a swing, like they're kind of
`swinging the results to try to pull out the ones
`that had a positive response and ignoring the
`majority of them that did not show an effect.
` Q. So just to be clear, in the first sentence
`under Mean change in OSDI score, the paper reports a
`result that you don't quote or mention in your
`declaration; is that right?
` A. Because my declaration was meant to show
`the faults with the paper, and the main outcome
`measure did not have a significant result; and the
`numerous other comparisons, for example just looking
`at mean change in the overall group and those with
`moderate and severe OSDI symptoms, did not show a
`significant difference between the groups.
` Q. So in your declaration you quoted the
`results that don't show a statistical difference,
`and you omitted the results that do show a
`statistical difference, is that fair?
` A. The point of my declaration was to show
`the faults with this paper, so this was highlighting
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`Page 28
`
`where the issues are with this paper.
` Q. Okay. And so you did not report in your
`declaration the results of that first sentence under
`Mean change in OSDI scores; is that right?
` A. Correct.
` Q. And on Page 1258, this is at the bottom of
`the left-hand column under the heading Outcomes
`stratified by duration of pretreatment, do you see
`that?
` A. Yes.
` Q. And on the sentence at the very bottom of
`that paragraph that carries over onto the next
`column, it states, "Regardless of baseline OSDI
`score, patients who were pretreated with
`BAK-preserved latanoprost, 0.005 percent for greater
`than 24 months, before entering the study were
`significantly more likely," in parenthesis "P equals
`0.03," end paren, "to improve to a normal OSDI score
`after 12 weeks if they were switched to BAK-free
`travoprost 0.004 percent," parenthesis,
`"47.9 percent of patients, 58 of 121," end paren,
`"than if they remained on BAK-preserved latanoprost
`0.005 percent," parenthesis, "33.9 percent of
`patients, 37 of 109," end paren, "as shown in
`Figure 5."
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`Page 29
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` Do you see that?
` A. Yes, I do.
` Q. And you don't quote that result in your
`declaration either, right?
` A. You know, I find this a really interesting
`result. Every other area that they've shown in this
`paper they would look at all four groups, so the
`entire group together and then break it into the
`subgroups of mild, moderate and severe. This is one
`section that they only look at the entire group
`together.
` Also they did look at different time
`points though. They looked at 1 to 6 months and 6
`to 24 months where they did find no difference
`between the groups, the only difference that they
`found, and that was the only other statistically
`significant result in this whole paper that had
`close to I think 20 comparisons, that found a
`difference.
` Q. And you didn't report that statistically
`significant difference in your declaration, right?
` A. That was not the point of my declaration.
`My point was to find that the paper was misleading
`as it is because it has so many results that did not
`show an effect, mind you the abstract conclusions
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`A Veritext Company
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`www.veritext.com
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`Page 30
`tried to suggest that it was beneficial, where I
`don't think you can conclude this when you actually
`critically look at the paper.
` Q. And just to be clear, you didn't quote or
`cite this result in your declaration?
` A. I did not.
` Q. Now, the first sentence of the Discussion
`section on Page 1259, which I won't read the entire
`thing, but about five lines down it states,
`transitioning to -- this is four lines down from the
`top, apologies. Four lines down from the top, that
`sentence states, "Transitioning to BAK-free
`travoprost 0.004 percent produced significant
`improvements in symptoms of OSD for patients who had
`mild OSDI scores at baseline and for patients who
`had been exposed to BAK-preserved latanoprost
`0.005 percent for more than 24 months prior to
`entering into the study."
` Do you see that?
` A. Yes, I do.
` Q. That part of the sentence fairly
`summarizes the two statistically significant results
`that we just looked at, right?
` A. That does not summarize this paper at all
`because they should also say, however, there was no
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`Page 31
`difference in the mean OSDI scores between the two
`groups; there was no difference in the subgroup that
`had moderate or severe disease; there was no
`difference in improvement in more than ten points in
`any of those four groups; there was no difference in
`absence of corneal staining between any of those
`four groups; and there was no difference in pati