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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`Article
`SIC
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`Retinal Physician Symposium Covers Broad Range
`of Topics
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`September 1, 2006
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`feature
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`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
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`https://www.retinalphysician.com/issues/2006/september-2006/retinal-physician-symposium-covers-broad-range-of
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`Regeneron Pharmaceuticals, Inc. Exhibit 2050 Page 1
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`6/25/23, 8:28 PM
`these studies.)
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`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.
`
`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.
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`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.
`
`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.
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`Regeneron Pharmaceuticals, Inc. Exhibit 2050 Page 3
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`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.
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`Regeneron Pharmaceuticals, Inc. Exhibit 2050 Page 4
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
`6/25/23, 8:28 PM
`"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.
`
`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.
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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`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
`
`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.
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`https://www.retinalphysician.com/issues/2006/september-2006/retinal-physician-symposium-covers-broad-range-of
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
`6/25/23, 8:28 PM
`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)
`
`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.
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`Regeneron Pharmaceuticals, Inc. Exhibit 2050 Page 7
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
`6/25/23, 8:28 PM
`"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 , a reduction
`3
`of 1.75 mm , (77% of the excess macular volume at baseline; P=.009). "In addition," said Dr. Nguyen,
`3
`"at month 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
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`https://www.retinalphysician.com/issues/2006/september-2006/retinal-physician-symposium-covers-broad-range-of
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`Regeneron Pharmaceuticals, Inc. Exhibit 2050 Page 8
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
`6/25/23, 8:28 PM
`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)
`
`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
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
`6/25/23, 8:28 PM
`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.
`
`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
`Archives
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`Regeneron Pharmaceuticals, Inc. Exhibit 2050 Page 10
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`Retinal Physician - Retinal Physician Symposium Covers Broad Range of Topics
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