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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`Article
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`Retinal Physician Symposium Covers Broad Range of Topics
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`September 1, 2006
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`0
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`feature
`Retinal Physician Symposium Covers Broad Range of Topics
`Top specialists provide insights on timely issues.
`COMPILED BY THE RETINAL PHYSICIAN EDITORIAL STAFF
`
`Many of the country's leading retina specialists gathered at the Atlantis resort on Paradise Island in the Bahamas from May
`31 to June 3 for the Second Annual Retinal Physician Symposium (RPS). The theme of this year's meeting was Current
`Concepts in Retinal Medicine. The meeting generated considerable excitement as Genentech chose the RPS to release
`the first results of the key PIER trial evaluating quarterly dosing for ranibizumab (Lucentis) in treating wet age-related
`macular degeneration (AMD).
`
`The following are condensed recaps of key presentations that took place during the 4 days of the Symposium.
`
`WET AMD TREATMENTS
`Ranibizumab (Lucentis)
`
`A key focus of this year's RPS was the ongoing assessment of ranibizumab (Lucentis, Genentech). Interest was generated
`by 2 key events: the release of 1-year data from the PIER trial and the expectation that ranibizumab would be approved by
`the Food and Drug Administration shortly after the Symposium concluded. Indeed, ranibizumab was approved on June 30
`as a treatment for wet AMD.
`
`Peter Kaiser, MD, provided a recap of the key clinical trials for ranibizumab, including the 2 pivotal phase 3 studies,
`MARINA and ANCHOR. He also noted other, more narrowly focused studies of ranibizumab such as SAILOR, FOCUS, and
`PrONTO. (Retinal Physician has previously reported on these studies.)
`
`Based on the already completed key studies, Dr. Kaiser concluded that Lucentis has shown itself to be an efficacious drug
`with an excellent safety profile. He noted that the range of adverse events seen in ranibizumab trials "were really limited to
`things that we've come to expect with intravitreal injections."
`
`David Brown, MD, provided new information when he announced the 1-year results of the PIER study, which was primarily
`designed to determine whether ranibizumab could be injected quarterly rather than monthly (after 3
`initial monthly injections) and maintain its effectiveness.
`
`Dr. Brown reported that the PIER study showed ranibizumab to be a safe drug. However, while quarterly dosing on average
`provided a 15- to 16-letter improvement over sham injections, the visual acuity of patients receiving quarterly injections of
`ranibizumab had on average returned to baseline by month 12.
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`The PIER data have led Genentech to recommend that patients receive either monthly injections of ranibizumab, or have
`their retreatment schedules determined through individualized testing.
`
`Bevacizumab (Avastin)
`
`The update on bevacizumab (Avastin, Genentech) was presented by Philip Rosenfeld, MD, PhD, who pioneered the use of
`bevacizumab as an off-label therapy for the treatment of wet AMD.
`
`Dr. Rosenfeld described how he had initially recognized the molecular similarities between ranibizumab and bevacizumab
`and determined that bevacizumab might be an effective treatment for wet AMD. He began with intravenous delivery of
`bevacizumab to a few wet AMD patients.
`
`Dr. Rosenfeld said he was well aware of systemic side effects that occurred with some cancer patients treated with
`bevacizumab, though he did not see those side effects in his AMD patients. However, he wanted to avoid the potential risk
`of systemic side effects and switched to intravitreal injection as the delivery method for bevacizumab.
`
`Dr. Rosenfeld reported on a patient who did not respond to photodynamic therapy (PDT), triamcinolone acetonide
`(Kenalog, Bristol-Myers Squibb), or pegaptanib sodium (Macugen, OSI), but who demonstrated significant and long-lasting
`visual improvement after just 1 injection of 1.25 mg of bevacizumab.
`
`In terms of safety, he noted that short-term data on 7000 bevacizumab injections raised no major safety concerns.
`
`"No apparent safety signals were identified," he reported.
`
`Dr. Rosenfeld concluded his presentation by saying that retina specialists should not feel guilty about using bevacizumab
`as a treatment for wet AMD.
`
`"It's legal, and it's ethical if you're using good clinical judgment," he asserted. "Obviously, we do need prospective clinical
`trials."
`
`Other Pharmacotherapies
`
`Peter Kaiser, MD, discussed several potential but lesser-known wet AMD therapies that are currently in clinical trials —
`vascular endothelial growth factor (VEGF) Trap (Regeneron), RNA interference (being developed by both Acuity
`Pharmaceuticals and Sirna Therapeutics), and squalamine (Evizon, Genaera).
`
`Dr. Kaiser finds VEGF Trap particularly interesting because in creating a decoy receptor for VEGF, it binds well to all forms
`of VEGF and remains effective at low concentrations, possibly offering a longer-lasting duration of action.
`
`Following a promising 6-week, 21-patient phase 1 trial during which the median improvement in visual acuity was 13 letters,
`Regeneron has initiated a larger phase 2 trial to determine safety and efficacy at doses up to 4 mg.
`
`The mechanism of action of RNA interference is to silence VEGF-producing genes through the injection of a form of
`double-stranded RNA. Sirna has completed a promising 26-patient, phase 1 trial that consisted of 1 injection. The Sirna
`compound, which acts against the VEGF receptor, demonstrated improved or stabilized vision in 96% of the study
`population, with 23% of patients showing a 3 line vision gain at 8 weeks. Sirna is now forming a phase 2 trial.
`
`Acuity has conducted a 15-patient, 2 injection phase 1 trial with its Cand5 compound, which attacks VEGF directly. In this
`study, 80% of patients demonstrated stable or improved vision. Dr. Kaiser reported that the safety profile of Cand5 proved
`to be excellent in this trial. A phase 2 trial is currently nearing completion.
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`Dr. Kaiser briefly mentioned squalamine, an antiangiogenic that is given intravenously and that showed some ability to
`stabilize vision in phase 2 trials. A new, dose-escalating trial of squalamine has now been initiated.
`
`PDT and Intravitreal Steroids
`
`Albert Augustin, MD, reported on an interesting combination called "triple therapy" in which the patient is treated with an
`anti-inflammatory steroid, bevacizumab, and modified PDT with a lower light dose.
`
`Dr. Augustin said that in 1 series of 64 eyes, 7 patients who received triple therapy all showed significant improvement in
`visual acuity in just 1 treatment cycle. A second bevacizumab injection was performed in only 7 eyes.
`
`"We believe this is a more finite treatment," said Dr. Augustin. "It's more a cure vs a suppression of the disease process. Up
`to now, we haven't seen any steroid-related or other severe side effects of the treatment."
`
`The PrONTO Study
`
`Dr. Rosenfeld had the idea which led to the PrONTO study after treating several patients with ranibizumab who did not
`require additional retreatment for as long as
`31 months. In fact, their vision continued to improve without retreatment. He determined that patients responded differently
`to this therapy and that retreatment could be determined on an individual basis.
`
`Dr. Rosenfeld reasoned that vision loss was gradual as the fluid accumulated and that optical coherence tomography
`(OCT) was reliable in detecting the fluid before it became symptomatic. Initially, all patients in the study received 3 monthly
`injections. They received additional injections only if the OCT measurements showed a need for retreatment.
`
`"Our questions were: how quickly does the OCT improve once we start injecting? How quickly does the visual acuity
`improve? And can these visual acuity improvements be maintained 2 years if we use this prn regimen?"
`
`The criteria for retreatment as measured by OCT were essentially one or more of the following: loss of at least 5 letters of
`vision, evidence of fluid, increase in central retinal thickness, new hemorrhage, and/or new evidence of classic choroidal
`neovascularization (CNV).
`
`Using these criteria, the mean number of injections per patient in year 1 of a 2-year 40-patient study was 5.5, though at
`least 1 patient received 13 injections. Clearly, the need for re-injection is unpredictable and varies from individual to
`individual. The PrONTO study offers one way to determine individual retreatment schedules.
`
`OCT Assessments of Lucentis
`
`Dr. Brown reported on quantitative vs qualitative OCT assessments of disease progression following treatment with
`ranibizumab.
`
`He noted that 4 different types of edema routinely return following treatment with ranibizumab. These are diffuse edema,
`intraretinal cysts, subretinal edema, and subretinal pigment epithelium fluid.
`
`"A patient has anti-VEGF therapy and gets a nice response," noted Dr. Brown. "With time, after treatment, you get diffuse
`edema. In other words, there's a thickening but no bubbles. This will only be shown by quantitative OCT if it accurately
`measures the retinal boundaries."
`
`Dr. Brown reports that in performing quantitative OCT assessments following anti-VEGF treatments, the error rate in
`identifying the need for retreatment can be as high as 70%. This is because the computer is prone to fixation errors, has
`difficulty in finding retinal boundaries, and fails to note the presence of subretinal pigment epithelium fluid.
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`With qualitative OCT assessment, the presence of fluid is visible and easy to detect. When fluid is detected, it is
`recommended that the retina specialist initiate retreatment.
`
`"As Phil (Rosenfeld) says, he treats when he sees fluid," noted Dr. Brown.
`
`High-Resolution SLO/OCT: The Future
`
`Dr. Rosenfeld reported on the anticipated arrival of "next-generation" OCT technology, which is called spectral domain and
`is currently being developed by several competing companies, including Carl Zeiss Meditec (Dublin, Calif) and Topcon
`(Paramus, NJ). Dr. Rosenfeld predicts that one or more of these systems will be commercially available within the next
`year.
`
`The advantages of spectral domain include increased speed, no moving parts, and 2000 detector elements that generate
`29000 lines per second compared to 400 lines per second for today's OCT-3. The result is better sensitivity, higher
`resolution, and 3-D imaging.
`
`"So, we are going to have higher resolution. It's going to be faster and you are going to be able to reconstruct images.
`You're going to be able to precisely place where the pathology is in the different layers of the retina based on the vascular
`landmarks of the fundus image. You are going to be able to do a lot of neat things because you will have this huge
`database that can be manipulated any way you want," concluded Dr. Rosenfeld.
`
`SURGERY
`Surgery for AMD: Is It Dead?
`
`Paul Tornambe, MD, says he never felt that surgery was alive for AMD. Dr. Tornambe says, "Any disease where you treat
`the effect of the stimulus rather than treating the stimulus is not going to be successful." He says "that until we are able to
`do something directly with the up-regulation of a VEGF gene, that as long as VEGF keeps getting produced, we're going to
`have to keep retreating these people." Dr. Tornambe believes that something has to occur further upstream to be effective.
`
`He also believes choroidal neovascular membrane (CNVM) removal is "dead" and that the Submacular Surgery Trials
`(SST) showed really no visual benefit. Dr. Tornambe is disappointed with the results in dealing with large clots. He thinks
`that the intravitreal injection of dexamethasone and bevacizumab or ranibizumab is exciting and that drugs will minimize the
`damage that is ultimately done.
`
`"Ninety-five percent of the macula operations we perform now will not be performed in 5 years, but I think we're very
`innovative, and we certainly try everything once," says Dr. Tornambe.
`
`PREVENTION OF AMD
`AMD: Genetics and Nutrition
`
`Darius Moshfeghi, MD, stated in his Nutrition, AREDS, AREDS II presentation that the AREDS trial, "has demonstrated the
`feasibility and efficacy of antioxidant plus zinc supplementation in preventing progression to advanced forms of AMD in
`patients with intermediate and advanced forms of AMD."
`
`In addition, Dr. Moshfeghi said the AREDS formulation resulted in positive visual acuity outcomes relative to placebo.
`Lastly, the AREDS II trial is enrolling patients to determine the additional benefit, if any, of xanthophyll and/or omega-3 long-
`chain polyunsaturated fatty acid supplementation in prevention of progression of AMD.
`
`Cataract Surgery and Development of Advanced AMD
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`Susan Bressler, MD, gave a presentation on the effect of cataract surgery on the development of neovascular AMD. Dr.
`Bressler stated that multiple analytic approaches on a large, well-categorized cohort (AREDS) provides no clear evidence
`of an adverse association between cataract surgery and development of neovascular AMD and that AMD patients in need
`of cataract surgery can probably be reassured of little to no increased risk of CNV due to surgery.
`
`Prevention of Advanced AMD
`
`During his talk on risk factors for choroidal neovascularization and AMD prevention trials, Allen C. Ho, MD, spoke about the
`exciting opportunities and developments with ranibizumab for patients with wet AMD. Dr. Ho covered prevention trials and
`the status of trials outside of AREDS — laser to drusen, rheopheresis, and the anecortave acetate trial. He said that lutein
`and zeoxanthine are going to be explored in the AREDS II trial. In addition, Dr. Ho is interested in docosahexaenoic acid
`(DHA) and elco-
`sapentanoic acid and said that omega-3 fatty acids are thought to be protective. He believes that the positive effects of
`DHA are very suggestive and compelling.
`
`Dr. Ho is interested in laser to drusen. He likes the notion of trying to modify the thickened Bruch's membrane that might be
`a stimulus for choroidal neovascularization or atrophic AMD, however, preliminary studies did not support laser to drusen
`outside the confines of a clinical trial. He thinks that rheotherapy is a very interesting concept but noted that the MIRA-1
`phase 3 trial of rheopheresis did not meet the primary efficacy outcome; another phase 3 trial is in planning stages because
`the initial study may have had significant and real confounder variables. He highlighted the anecortave acetate study, which
`is a pharmacologic prevention trial. He believes the drug to be most apt for prevention of choroidal neovascularization and
`may be a useful adjunct to Lucentis in the treatment of existing CNV.
`
`OCULAR TUMORS
`Experimental Therapies
`
`Timothy Murray, MD, reported some promising results in animal studies for microvascular targeting, which combines
`pharmacological therapies for the treatment of retinoblastoma. "Combining anecortave acetate (Retaane, Alcon) and
`carboplatin essentially reduces tumor size and has the potential to eradicate tumor," explained Dr. Murray. He noted the
`potential of such a therapy depends on its dosage and delivery schedule.
`
`DIABETIC MACULAR EDEMA
`Pegaptanib Sodium (Macugen)
`
`Christine Gonzales, MD, spoke about the phase 2 trial evaluating pegaptanib sodium for diabetic macular edema (DME).
`This study was designed to explore the safety and efficacy of the drug through week 36 for patients given pegaptanib every
`6 weeks for up to 36 weeks.
`
`Patients were randomized 1:1:1 into 3 different doses of pegaptanib or sham injection. Physicians had to feel comfortable
`deferring focal laser treatment for up to 16 weeks.
`
`Dr. Gonzales reported a treatment effect as early as 6 weeks and a significant difference between the sham group and the
`pegaptanib group at
`36 weeks. "Subjects that were assigned to Macugen in the phase 2 trial had better visual acuities," reported Dr. Gonzales.
`"They were more likely to show a reduction in the center thickness, and less likely to need focal laser when compared to
`the sham group."
`
`Ranibizumab (Lucentis)
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`Quan Dong Nguyen, MD, presented the 1-year interim results of the Ranibizumab for Edema of the MAcula in Diabetes
`(READ) study. In this READ phase 1 trial, intravitreal ranibizumab was safe and tolerable at multiple injections for patients
`who have DME that has been refractory to laser photocoagulation or intravitreal injections of triamcinolone. No ocular or
`systemic side effects and no inflammation had been observed with repeated dosages of 0.5 mg of ranibizumab.
`
`"The primary outcome of the READ study, beyond safety, was change in foveal thickness between baseline and 7 months
`and the secondary outcome measures were changes from baseline in visual acuity and macular volume," explained Dr.
`Nguyen. Dr. Nguyen reported that at 7 months, (1 month after the fifth injection), the mean foveal thickness was 257 μm, a
`reduction of 246 μm (85% of the excess foveal thickness present at baseline; P=.005). The macular volume was 7.47 mm ,
`3
`a reduction of 1.75 mm , (77% of the excess macular volume at baseline; P=.009). "In addition," said Dr. Nguyen, "at month
`3
`7, we observed a mean visual acuity of 40.4 letters (20/40), an improvement of 12.3 letters (P=.005)."
`
`Ruboxystaurin
`
`Dr. Kaiser presented results from the Diabetic Retinopathy Studies (DRS)-1 and 2 for this drug. He reported that protein
`kinase C beta inhibitor (Ruboxistaurin, Eli Lilly) showed it could reduce the risk of sustained, moderate vision loss over a 3-
`year time period in patients with moderate, severe, to very severe non-proliferative DR disease.
`
`"In addition, the drug was able to improve the number of patients with visual gain, specifically 3-line gainers with less
`decrease from baseline visual acuity in those patients receiving the drug," explained Dr. Kaiser. He concluded by saying the
`drug was being reviewed by the FDA.
`
`PROLIFERATIVE DIABETIC RETINOPATHY
`Vitrase, Plasmin
`
`Dr. Kuppermann discussed studies on these 2 drugs as agents for pharmacologic vitreolysis. Vitrase (purified ovine
`lyophilized hyaluronidase, ISTA Pharmaceuticals) completed 2 large phase 3 studies assessing its safety and efficacy for
`clearance of vitreous hemorrhage, but the 2 pivotal studies did not result in the drug being approved for that indication.
`"While Vitrase showed a clinical benefit in clearing vitreous hemorrhage in some eyes, the data did not show statistical
`significance in its 2 individual trials for a variety of complex reasons," explained Dr. Kuppermann.
`
`Vitrase is currently approved as a spreading agent for retrobulbar use, and is available as an off-label agent for intravitreal
`use. Dr. Kuppermann also discussed the use of Vitrase to induce a posterior vitreous detachment in patients with
`moderately severe non-proliferative diabetic retinopathy (PDR) in order to decrease the risk of progression to proliferative
`diabetic retinopathy. However, to date, only a pilot trial for this indication has been conducted with Vitrase.
`
`Dr. Kuppermann also discussed the potential role of another agent for enzymatic vitreolysis, plasmin. He reported that 3
`types of plasmin were in various stages of development — autologous plasmin, pooled plasmin, and microplasmin.
`Autologous plasmin is difficult to develop as a commercial product because it entails using an affinity cartridge to extract the
`plasmin from the patients' blood. Dr. Kuppermann saw either pooled plasmin (Bausch & Lomb) or microplasmin
`(ThromboGenics) as the more likely plasmin-based future of therapeutic agents. Dr. Kuppermann explained that pooled
`plasmin and microplasmin are being studied as surgical adjuvants for vitrectomy surgery in ongoing trials, and other
`indications are being explored as well.
`
`He also pointed out some other possible indications for both drugs. "Future potential uses include the possibility of using
`vitreolytic agents such as Vitrase and plasmin for floaters, as well as modifying or enhancing the efficacy of other
`ophthalmic drugs," said Dr. Kuppermann.
`
`Bevacizumab (Avastin)
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`Robert Avery, MD, discussed his off-label use of bevacizumab for patients with PDR. He found the therapy to be useful in
`an adjunctive role because of its ability to treat patients who cannot be fully treated with panretinal photocoagulation or
`patients with DME and severe PDR. Dr. Avery explained that bevacizumab was helpful for DME and PDR patients in
`preventing exacerbation of their edema. He pointed out that the drug's efficacy and safety profile were promising as well.
`
`"It works at very low doses, and that may be in part because it doesn't have to penetrate the retina to get where the disease
`is," stated Dr. Avery. "The vessels in diabetes are on the surface of the retina, and are on the iris, so there's no retinal
`penetration concern." He concluded by saying prospective trials were needed, but he was "excited" to have another PDR
`treatment tool.
`
`PEDIATRIC RETINA
`FEVR and ROP
`
`Michael Trese, MD, presented on the pharmacologic management if pediatric retinal vascular disease, specifically on the
`use of pegaptinib sodium for blocking VEGF in familial exudative vitreoretinopathy (FEVR) and retinopathy of prematurity
`(ROP). Dr. Trese reported that in his experience, pegaptanib sodium reduces subretinal exudates in FEVR with repeat
`injection infrequently required. However, there is evidence showing that preretinal neovascularization is less responsive to
`therapy. In the treatment of ROP, pegaptanib sodium appears not to be as effective for rescue therapy as originally thought,
`However, Dr. Trese said that anti-VEGF therapy may be relative to the involution of tractional detachment cells and the
`hyaloid and tunica vasculosa lentis, so earlier therapy with pegaptanib sodium may have a favorable effect for ROP as an
`alternative to laser therapy, which destructs two-thirds of the retina.
`
`"We do think that further study is needed to look at both — maybe selective, but also non-selective blockage of VEGF-A, to
`see if that's something which will improve our outcomes," said Dr. Trese.
`
`RETINAL VASCULAR DISEASE
`RVO and SCORE
`
`In her discussion on the NEI-sponsored SCORE study, Sharon Fekrat, MD, FACS, reviewed the 2005 Preferences and
`Trends (PAT) survey results on how retinal specialists treat retinal venous occlusive diseases (RVO), with the results being
`widely spread between grid pattern laser photocoagulation, intravitreal triamcinolone injection, and a combination of both
`approaches, among others. The SCORE study's goal is to assess the risks and the benefits of these 2 widely used
`therapies for RVO. Dr. Fekrat discussed several cases where triamcinolone has shown promise and outlined the SCORE
`protocol and its entry criteria. The SCORE study may indeed answer many unanswered questions about the use of
`intravitreal triamcinolone in eyes with RVO, she concluded.
`
`Bevacizumab for Retinal Vascular Disease
`
`Dr. Rosenfeld reported several cases where bevacizumab was used to treat retinal vascular disease with positive
`outcomes. Many of the cases presented were patients who had undergone previous therapy with intravitreal triamcinolone.
`Some of the patients responded well to triamcinolone but, because of IOP rises, required alternative therapy. Not all the
`patients did well on bevacizumab due to fluid persistence, and not all patients experienced visual acuity improvement that
`correlated with the anatomic improvement after bevacizumab injections. Of the treatment option for retinal vascular
`disease, Dr. Rosenfeld said, " We have limited data available. The duration of effect is quite unpredictable, and usually,
`multiple injections are necessary."
`
`He added that he would still consider triamcinolone therapy better for patients with risks associated with glaucoma and
`cataracts, as well as those for whom frequent injections present a problem or for those who show fluid persistence despite
`monthly injections with bevacizumab.
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`Editor's Note: Expanded coverage of the presentations from the Second Annual RPS will be published in a special edition
`of Retinal Physician, coming this November.
`
`Please join us next year for Retinal Physician Symposium 2007, April 12-15, 2007 at Sanibel Harbour Resort in Fort Myers,
`Fla. The Resort boasts all-new luxurious accommodations embodying the essence of seaside grandeur. Please contact
`Heather Seasholtz, director of the Conference Group at 215-643-8073 with any questions about the meeting.
`
`Retinal Physician, Issue: September 2006
`Table of Contents
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