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News Article | November 17, 2016

GAINESVILLE, Fla., and CAMBRIDGE, Mass., Nov. 17, 2016 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced the appointment of Michael Goldstein, M.D., M.B.A. as Chief Medical Officer (CMO) effective as of December 1, 2016. Dr. Goldstein will be responsible for leading the company’s clinical trials, providing medical oversight, and contributing to the overall strategic direction of the company. AGTC’s current Vice President and CMO, Jeffrey D. Chulay, M.D., DTM&H, will remain with the company as Executive Director of Clinical Strategy.   “Mike’s extensive clinical background in ophthalmology, along with his experience serving as CMO of a publicly traded company, will further strengthen our management team as we advance our lead gene therapy development programs,” said Sue Washer, President and CEO of AGTC. “We recognize Jeff’s substantial contributions throughout his ten years with AGTC and look forward to his ongoing contribution in his new role. We are extremely fortunate that the company will be able to continue to benefit from Jeff’s experience in gene therapy and his strong relationships with key opinion leaders to assure a smooth transition as Mike assumes the CMO position.” Prior to joining AGTC, Dr. Goldstein held multiple roles of increasing responsibility with Eleven Biotherapeutics, including as Chief Medical Officer and Vice President of Clinical Research, where he worked with Eleven’s team to bring a novel treatment for dry eye disease from early research to a completed pivotal trial. Since 2002 he has served as Co-Director of Cornea and External Disease Service and Assistant Professor of Ophthalmology at the New England Eye Center. Previously, he was Director of Refractive Surgery Service and Assistant Professor of Ophthalmology at the University of Florida College of Medicine. Dr. Goldstein has published extensively and is a reviewer for multiple ophthalmology scientific journals. He holds an M.D. from Northwestern University Medical School, an M.B.A. from Northwestern University’s J.L. Kellogg Graduate School of Management and a B.A. in Political Economy from Williams College. “AGTC’s gene therapy platform has multiple opportunities to provide long-term value to patients with inherited diseases and I am excited to be joining the company at this critical time,” said Dr. Goldstein. “My top priority is completing enrollment and analysis of a full data set from the ongoing Phase 1/2 clinical trials for the company’s XLRS and CNGB3 (achromatopsia) product candidates and both of the planned Phase 1/2 clinical trials for its CNGA3 (achromatopsia) and XLRP product candidates. I look forward to joining a team that has already laid the groundwork to realize the promise of gene therapy.” AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC's lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC's product pipeline includes six named ophthalmology development programs across five targets (X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), achromatopsia, wet age-related macular degeneration and blue cone monochromacy), two non-ophthalmology programs (alpha-1 antitrypsin deficiency and adrenoleukodystrophy) and AGTC is continuing to develop early research studies in additional indications. The company is also exploring genetic defects in cells in the inner ear that lead to deafness and expects to advance several product candidates into development within the next few years. AGTC employs a highly targeted approach to selecting and designing its product candidates, choosing to develop therapies for indications having high unmet medical need, clinical feasibility and commercial potential. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as, expertise in the formulation, manufacture and physical delivery of gene therapy products. This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others:  no gene therapy products have been approved in the United States and only two such products have been approved in Europe; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate; uncertainty inherent in the regulatory review process; risks and uncertainties associated with drug development and commercialization; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading “Risk Factors” in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2016, as filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Sobrin L.,Massachusetts Eye and Ear Infirmary | Seddon J.M.,New England Eye Center | Seddon J.M.,Tufts University
Progress in Retinal and Eye Research | Year: 2014

Age-related macular degeneration (AMD) is a common cause of irreversible visual loss and the disease burden is rising world-wide as the population ages. Both environmental and genetic factors contribute to the development of this disease. Among environmental factors, smoking, obesity and dietary factors including antioxidants and dietary fat intake influence onset and progression of AMD. There are also several lines of evidence that link cardiovascular, immune and inflammatory biomarkers to AMD. The genetic etiology of AMD has been and continues to be an intense and fruitful area of investigation. Genome-wide association studies have revealed numerous common variants associated with AMD and sequencing is increasing our knowledge of how rare genetic variants strongly impact disease. Evidence for interactions between environmental, therapeutic and genetic factors is emerging and elucidating the mechanisms of this interplay remains a major challenge in the field. Genotype-phenotype associations are evolving. The knowledge of non-genetic, modifiable risk factors along with information about heritability and genetic risk variants for this disease acquired over the past 25 years have greatly improved patient management and our ability to predict which patients will develop or progress to advanced forms of AMD. Personalized medicine and individualized prevention and treatment strategies may become a reality in the near future. © 2014.

Manjunath V.,New England Eye Center | Taha M.,New England Eye Center | Fujimoto J.G.,Massachusetts Institute of Technology | Duker J.S.,New England Eye Center
American Journal of Ophthalmology | Year: 2010

PURPOSE: To examine choroidal thickness and area in healthy eyes using spectral-domain optical coherence tomography (SD-OCT). DESIGN: Retrospective, observational case series. METHODS: Thirty-four eyes (34 subjects), with no retinal or choroidal disease, underwent high-definition raster scanning using SD-OCT with frame enhancement software. Choroidal thickness was measured from the posterior edge of the retinal pigment epithelium to the choroid/sclera junction at 500-μm intervals up to 2500 μm temporal and nasal to the fovea. The central 1-mm area of the choroid was also measured, along with foveal thickness of the retina. All measurements were performed by 2 independent observers. Statistical analysis was used to correlate inter-observer findings, choroidal thickness and area measurements with age, and choroidal thickness with retinal foveal thickness. RESULTS: The 34 subjects had a mean age of 51.1 years. Reliable measurements of choroidal thickness were obtainable in 74% of eyes examined. Choroidal thickness and area measurements had strong inter-observer correlation (r = 0.92, P < .0001 and r = 0.93, P < .0001 respectively). Area had a moderate negative correlation with age (r = -0.62, P < .0001) that was comparable to the correlation between mean subfoveal choroidal thickness and age (r = -0.61, P < .0001). Retinal and choroidal thickness were found to be poorly correlated (r = -0.23, P = .18). Mean choroidal thickness showed a pattern of thinnest choroid nasally, thickening in the subfoveal region, and then thinning again temporally. Mean subfoveal choroidal thickness was found to be 272 μm (SD, ± 81 μm). CONCLUSIONS: Choroidal thickness can be measured using SD-OCT high-definition raster scans in the majority of eyes. Choroidal thickness across the macula demonstrates a thin choroid nasally, thickest subfoveally, and again thinner temporally, and a trend toward decreasing choroidal thickness with age. © 2010 Elsevier Inc. All rights reserved.

Manjunath V.,New England Eye Center | Goren J.,New England Eye Center | Fujimoto J.G.,Massachusetts Institute of Technology | Duker J.S.,New England Eye Center
American Journal of Ophthalmology | Year: 2011

Purpose: To understand the relationship between choroidal thickness and various disease factors in patients with age-related macular degeneration (AMD) using spectral-domain optical coherence tomography. Design: Cross-sectional, retrospective analysis. Methods: Fifty-seven eyes of 47 patients with wet and dry AMD seen between November 2009 and January 2010 at the New England Eye Center, Boston, Massachusetts, were analyzed. Choroidal thickness was measured by 2 independent observers at 11 sites with high-definition horizontal 1-line raster scans through the foveal center. A retrospective chart review was performed to obtain data concerning duration of disease, number of intravitreal antivascular endothelial growth factor injections, visual acuity, lens status, and concomitant retinal pathologic features. The Pearson correlation and Student t test were used for statistical analysis for assessment of choroidal thickness changes in wet and dry AMD. Results: The choroid in eyes with wet and dry AMD demonstrated a wide range of thicknesses above and below the normal mean (range, 77.5 to 399.5 μm; standard deviation [SD], 90.2). Nearly one third (33.3%) of the eyes with AMD measured less than 1 SD below the mean. Eyes with wet AMD demonstrated a mean subfoveal choroidal thickness of 194.6 μm (SD, 88.4; n = 40) compared with 213.4 μm (SD, 92.2; n = 17) in the dry AMD group. The choroidal thickness in eyes with dry AMD was correlated inversely with age (r = -0.703; P =.002); however, analysis of the number of intravitreal antivascular endothelial growth factor injections, number of years of disease, and visual acuity failed to demonstrate any significant correlations with choroidal thickness. Conclusions: This study demonstrated that choroidal thickness can be measured by spectral-domain optical coherence tomography and that variable choroidal thickness exists among patients with the clinical diagnosis of wet and dry AMD. However, it is unclear at this time why in some eyes, choroidal thickness either increases or decreases with the disease. Further studies need to be carried out to understand the significance of choroidal thickness with respect to visual function and disease progression over time. © 2011 Elsevier Inc.

Seddon J.M.,New England Eye Center | Seddon J.M.,Tufts University
Investigative Ophthalmology and Visual Science | Year: 2013

Age-related macular degeneration (AMD), cataract, glaucoma and diabetic retinopathy are common causes of visual loss. Both environmental and genetic factors contribute to the development of these diseases. The modifiable factors related to some of these age-related and visually threatening diseases are smoking, obesity, and dietary factors, and a cardiovascular risk profile. Many common and a few rare genetic factors are associated with AMD. The role of genetic variants for the other diseases are less clear. Interactions between environmental, therapeutic, and genetic factors are being explored. Knowledge of genetic risk and environmental factors, especially for AMD, has grown markedly over the past 2.5 decades and has led to some sight-saving approaches in preventive management. © The Association for Research in Vision and Ophthalmology, Inc.

Reynolds R.,New England Eye Center | Rosner B.,Channing Laboratory | Seddon J.M.,New England Eye Center | Seddon J.M.,Tufts University
Ophthalmology | Year: 2013

Objective: To investigate associations between dietary omega-3 fatty acids and other fat intake, genes related to age-related macular degeneration (AMD), and progression to geographic atrophy (GA). Design: Observational analysis of a prospective cohort. Participants: A total of 2531 individuals from the Age-Related Eye Disease Study, among which 525 eyes progressed to GA and 4165 eyes did not. Methods: Eyes without advanced AMD at baseline were evaluated for progression to GA. Behavioral data, including smoking and body mass index measurements, were collected at baseline using questionnaires. Dietary data were collected from food frequency questionnaires (FFQs) at baseline. Omega-3 fatty acids (docosahexaenoic acid [DHA] and eicosapentaenoic acid [EPA]), omega-6 fatty acids, monounsaturated, saturated, polyunsaturated, and total fat were adjusted for sex and calories and divided into quintiles (Q). Eight single nucleotide polymorphisms in 7 genes (CFH, ARMS2/HTRA1, CFB, C2, C3, CFI, and LIPC) were genotyped. Cox proportional hazards models were used to test for associations between incident GA and intake of dietary lipids and interaction effects between dietary fat intake and genetic variation on risk of GA. Main Outcome Measures: Associations between dietary fat intake reported from FFQs, genetic variants, and incident GA. Results: Increased intake of DHA was significantly associated with reduced risk of progression to GA in models with behavioral factors (model A) plus genetic variants (model B) (P trend = 0.01 and 0.03, respectively). Total omega-3 long chain polyunsaturated (DHA + EPA) fatty acid intake was significantly associated with reduced risk of progression in model B (P trend = 0.02). Monounsaturated fat was associated with increased risk in model A (P trend = 0.05). DHA intake was significantly associated with reduced risk of incident GA among those with the ARMS2/HTRA1 homozygous risk genotype (hazard ratio [HR] Q5 vs Q1, 0.4; P = 0.002; P for interaction between gene and fat intake = 0.05). DHA was not associated with reduced risk of GA among those with the homozygous ARMS2/HTRA1 nonrisk genotype (HR, 1.0; P = 0.90). Conclusions: Increased self-reported dietary intake of omega-3 fatty acids is associated with reduced risk of GA and may modify genetic susceptibility for progression to GA. © 2013 American Academy of Ophthalmology.

PURPOSE:: To characterize the features of choroidal neovascularization (CNV) in neovascular age-related macular degeneration with spectral domain optical coherence tomography angiography (OCTA) and to determine whether OCTA can be used to determine clinical activity of CNV. METHODS:: Observational, retrospective, consecutive case series. RESULTS:: Optical coherence tomography angiography revealed CNV in 28 eyes (62.2%) while 17 eyes (37.8%) did not demonstrate CNV vessels. Choroidal neovascularization was classified as well circumscribed in 12 eyes (42.8%) and poorly circumscribed in 16 eyes (57.2%). Twenty-two eyes with a CNV on OCTA were clinically active, whereas six eyes with visible CNV on OCTA were clinically inactive. Of the 17 eyes that did not have evidence of CNV on OCTA imaging, 14 were clinically inactive and 3 were clinically active. Presence of CNV on OCTA correlated with clinical activity and absence of CNV correlated with inactivity (P < 0.0001). CONCLUSION:: Optical coherence tomography angiography is a noninvasive imaging technique that can be used to visualize blood flow comprising CNV. Optical coherence tomography angiography detects CNV vessels in some albeit not all eyes with neovascular age-related macular degeneration. Although the presence or absence of CNV vessels on OCTA highly correlated with clinical activity of CNV, the morphologic appearance of CNV on OCTA did not have significant correlation with clinical activity. © 2016 by Ophthalmic Communications Society, Inc.

Regatieri C.V.,New England Eye Center
Ophthalmic surgery, lasers & imaging : the official journal of the International Society for Imaging in the Eye | Year: 2011

Spectral-domain optical coherence tomography (SD-OCT) has emerged as the ancillary examination of choice to assist the diagnosis and management of neovascular age-related macular degeneration (AMD). SD-OCT provides more detailed images of intraretinal, subretinal, and subretinal pigment epithelium fluid when compared to time-domain technology, leading to higher and earlier detection rates of neovascular AMD activity. Improvements in image analysis and acquisition speed make it important for decision-making in the diagnosis and treatment of this disease. However, this new technology needs to be validated for its role in the improvement of visual outcomes in the context of anti-angiogenic therapy. Copyright 2011, SLACK Incorporated.

Alasil T.,New England Eye Center | Waheed N.K.,New England Eye Center
Current Opinion in Ophthalmology | Year: 2014

PURPOSE OF REVIEW: Diabetic retinopathy is the leading cause of visual impairment in working-age adults worldwide. Pan retinal photocoagulation (PRP) has provided an effective treatment to decrease the risk of severe vision loss in patients with proliferative diabetic retinopathy for the past four decades. Pattern scan laser (PASCAL) was developed to minimize the side effects of PRP. The purpose of this review is to discuss the differences between the traditional argon laser and the PASCAL. RECENT FINDINGS: PASCAL can achieve comparable results with the conventional argon PRP in the treatment of patients with diabetic retinopathy. The PASCAL delivery system creates well aligned arrays of retinal lesions in a shorter period. PASCAL provides amore comfortable profile when compared to the argon laser. SUMMARY: The PASCAL is now being substituted for the conventional argon laser for PRP in many clinics. Ophthalmologists should keep in mind that adjusting the PASCAL settings (including the duration, number, and size of laser burns) might become necessary to maintain regression and eliminate recurrence of neovascularization in patients with proliferative diabetic retinopathy. Further studies are needed to determine the parameters for optimal safety and efficacy on the PASCAL. © 2014 Wolters Kluwer Health.

Adhi M.,New England Eye Center | Duker J.S.,New England Eye Center
Current Opinion in Ophthalmology | Year: 2013

Advances in OCT technology provide for better understanding of pathogenesis, improved monitoring of progression and assistance in quantifying response to treatment modalities in diseases of the posterior segment of the eye. Further improvements in both hardware and software technologies should further advance the clinician's ability to assess and manage chorioretinal diseases. © 2013 Wolters Kluwer Health.

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