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WALTHAM, Mass., April 09, 2018 (GLOBE NEWSWIRE) — EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage, specialty pharmaceutical company with two proprietary platform technologies for treating diseases and disorders of the eye, today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) responding to the Company’s amended investigational device exemption (IDE) application for a second pilot study of the Company’s lead product, EyeGate Ocular Bandage Gel (EyeGate OBG), a cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform being developed for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK).
In its letter, the FDA identified four deficiencies in the Company’s submission, requesting additional information on the manufacturing processes associated with the EyeGate OBG product. The primary comment relates to the validation of the filter specifically used for sterilization of the CMHA material, while the remaining comments include a request for clarification to the previously submitted data and modifications to the manufacturing process documents.
“We are pleased that our first IDE amendment addressed the majority of the 13 issues raised in the FDA’s initial response, and believe that the clarity of feedback provided in this letter gives us a clear path to approvability of the application,” said Stephen From, President and Chief Executive Officer of EyeGate. “We are now in the process of addressing the various points raised in the letter, mainly the validation of the sterile filtration of the CMHA material. According to the agency, one of the three filters used for validating the filter required for sterilizing the CMHA material did not pass the validation step by definition. To address this deficiency, our plan is to work with the manufacturer of the filter to complete the validation work using a different filter. We anticipate completing this work in the coming months, and are targeting the submission of a second amendment to the IDE application in July 2018. Assuming this next amendment is approved by the FDA, we would look to initiate the second EyeGate OBG pilot study in PRK patients later in the third quarter, with top-line data reported in Q4.”
The IDE seeks approval for a proposed second pilot study of EyeGate OBG, enrolling up to 45 subjects undergoing a bilateral PRK procedure in a reading center masked trial. The goal of this study is to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. The primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3. Subjects enrolled in the study will be randomized into three arms: EyeGate OBG administered four times daily (QID) for 14 days, EyeGate OBG administered eight times daily for three days, followed by QID administration for 11 days, and BCL with QID administration of artificial tears for 14 days.
In March 2018, the Company submitted an amended IDE comprising of the validation data on the manufacturing processes and bioburden tests related to production of EyeGate OBG, as well as data related to the analytical methods to identify and quantify impurities and degradation products.
The amended IDE submission is subject to review by the Center for Devices and Radiological Health (CDRH) of the FDA, and must be approved prior to initiating this study. Once submitted, the FDA will have 30 days to review the amendment and either request additional data or approve the initiation of the study.
About EyeGate
EyeGate is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products using its two proprietary platform technologies for treating diseases and disorders of the eye.
EyeGate’s CMHA-S platform is based on a cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S), a modified form of the natural polymer hyaluronic acid (HA), which is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries.
EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. For more information, please visit www.EyeGatePharma.com.
EyeGate Social Media
EyeGate uses its website (www.EyeGatePharma.com), Facebook page (https://ift.tt/g8FRpY EyeGatePharma/), corporate Twitter account (https://twitter.com/EyeGatePharma), and LinkedIn page (https://ift.tt/2GKHSV6) as channels of distribution of information about EyeGate and its product candidates. Such information may be deemed material information, and EyeGate may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor EyeGate’s website and its social media accounts in addition to following its press releases, SEC filings, public conference calls, and webcasts. The social media channels that EyeGate intends to use as a means of disclosing the information described above may be updated from time to time as listed on EyeGate’s investor relations website.
Forward-looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate’s EGP-437 combination product and those of Jade Therapeutics, Inc., a wholly owned subsidiary of EyeGate, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in EyeGate’s Annual Report on Form 10-K filed with the SEC on March 02, 2018 or described in EyeGate’s other public filings. EyeGate’s results may also be affected by factors of which EyeGate is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Contact:
Lee Roth / Janhavi Mohite
The Ruth Group for EyeGate Pharmaceuticals
646-536-7012 / 7026
lroth@theruthgroup.com / jmohite@theruthgroup.com
Global Pharmaceutical Analytical Testing Services Market: Snapshot
The global pharmaceutical analytical testing services market is poised to soar owing to the rising demand from pharmaceutical manufacturers and raw material suppliers. Delivering comprehensive pharmaceutical services in manufacturing and development have become the key concern of several companies. Numerous service providers are offering services such as pharma solutions, packaging, residual solvents, stability testing and storage, method validation, dissolution, raw material testing, leachable or extractable testing, and retrospective method validation.
A major trend observed in the global pharmaceutical analytical testing services market is outsourcing. Absence of the necessary set-up for performing every test in-house is one of the key reasons for outsourcing. The best method for handling tests such as process and facility validation, registration stability storage and testing, analytical testing that deploys expensive equipment, cleaning validations, and method development is outsourcing. Outsourcing to a specialty company provides experience and expertise in this domain. It also aids in bringing down the costs of maintenance, equipment, and validation. As a result, outsourcing is likely to contribute towards the expansion of the global pharmaceutical analytical testing market.
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The clinical bioanalytical testing segment is slated to grow at a considerable pace during the forecast period, attaining a significant share of the global market for pharmaceutical analytical testing services. The factors responsible for the growth of this region are stringent regulatory framework applicable to drug discovery and the rising number of clinical trials driven by the increasing incidence of diseases.
With the advent of several technological advancements, numerous new solutions are being developed. For example, in March 2017, a cost efficient system that enables pharmaceutical label-free ultra-high throughput screening has been launched by Bruker. The pharmaceutical industry has been increasingly deploying NMR fragment-based screening method, which has been incorporated into Bruker’s new software. Increased efficiency, productivity and reliability are some key features of this screening method.
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Pharmaceutical Analytical Testing Services Market: Comprehensive Overview
Pharmaceutical analytical testing services are services offered to several pharmaceutical manufacturers, product manufacturers, and raw material suppliers. The need for increased efficiency and cost reduction by pharmaceutical companies has led to the rising scope for outsourcing analytical testing services. Currently there are a number of companies focusing on providing comprehensive pharmaceutical manufacturing and development services such as manufacturing and packaging, pharmaceutical development, analytical testing services, and pharma solutions. Service providers are also offering several pharmaceutical analytical testing services, such as method development/ method validation, stability testing and storage, raw material testing, residual solvents, dissolution, retrospective method validation, and extractable/leachable testing.
The market for pharmaceutical analytical testing services has been analyzed by taking into consideration the revenue generated by various analytical testing services such as raw material testing, stability testing, and method validation and testing. The report gauges various trends in analytical services across four major geographies: North America, Asia Pacific, Europe, and the Rest of the World (RoW).
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Pharmaceutical Analytical Testing Services Market: Drivers and Restraints
The global market for pharmaceutical analytical testing services is driven by the growing need for the development and cost reduction of core competencies by pharmaceutical companies and the rising acceptance of outsourcing as a key business and growth strategy. Research studies have exhibited that in the year 2012, pharmaceutical and biotechnological companies spend an estimated US$190 mn on in-house analytical development as against the US$664 mn spent on outsourcing analytical testing services. This is likely to strengthen the growth of the market in the coming years.
On the other hand, the lack of skilled professionals and well-established healthcare infrastructure are some of the factors that threaten to hamper the growth of the pharmaceutical analytical testing services market. Apart from this, operational costs, fluctuations in good manufacturing practices (GMP), regulatory policies, and less turnaround times also impact the market growth.
Pharmaceutical Analytical Testing Services Market: Regional Outlook
North America is one of the leading regions in the pharmaceutical analytical testing services market and is driven by familiarity with the regulatory scenario and the presence of well-established outsourcing infrastructure. The growth landscape of the Europe pharmaceutical analytical testing services market is slowly catching up, experts have observed.
Countries in Asia Pacific present significant growth potential thanks to the presence of a large pool of skilled professionals and relatively low operational costs. Rising investments in research is also a major factor driving the APAC pharmaceutical analytical testing services market. Investments in routine testing, multiplex protein profiling, biologics such as RNA sequencing, and others are likely to give Asia Pacific the boost it needs over the course of the forecast period.
Pharmaceutical Analytical Testing Services Market: Key Players
Some of the leading pharmaceutical analytical testing service providers are Pace Analytical Services, Inc., Intertek Group plc, Aptuit, Inc., and West Pharmaceutical Services, Inc. The vendor landscape of the pharmaceutical analytical testing services market has evolved over the recent past owing to rising mergers, strategic parternships, and downsizing in the pharma sector. In addition to this, increased focus on strengthening internal core competencies and the rising need and demand for faster analytical response fuel the market for pharmaceutical analytical testing services.
HTF MI published a new industry research that focuses on Healthcare Analytical Testing Services market and delivers in-depth market analysis and future prospects of Global Healthcare Analytical Testing Services market. The study covers significant data which makes the research document a handy resource for managers, analysts, industry experts and other key people get ready-to-access and self-analyzed study along with graphs and tables to help understand market trends, drivers and market challenges. The study is segmented by Application/ end users [Pharmaceutical], products type [Method Validation, Environmental Monitoring, Bioanalytical Services, Stability & Microbial Testing] and various important geographies like United States, EU, Japan, China, India & Southeast Asia].
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The research covers the current market size of the Global Healthcare Analytical Testing Services market and its growth rates based on 5 year history data along with company profile of key players/manufacturers. The in-depth information by segments of Healthcare Analytical Testing Services market helps monitor future profitability & to make critical decisions for growth. The information on trends and developments, focuses on markets and materials, capacities, technologies, CAPEX cycle and the changing structure of the Global Healthcare Analytical Testing Services Market.
The study provides company profiling, product picture and specifications, sales, market share and contact information of key manufacturers of Global Healthcare Analytical Testing Services Market, some of them listed here are CRO. The market is growing at a very rapid pace and with rise in technological innovation, competition and M&A activities in the industry many local and regional vendors are offering specific application products for varied end-users. The new manufacturer entrants in the market are finding it hard to compete with the international vendors based on quality, reliability, and innovations in technology.
Global Healthcare Analytical Testing Services (Thousands Units) and Revenue (Million USD) Market Split by Product Type such as Method Validation, Environmental Monitoring, Bioanalytical Services, Stability & Microbial Testing. Further the research study is segmented by Application such as Pharmaceutical with historical and projected market share and compounded annual growth rate.
Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), and market share and growth rate of Healthcare Analytical Testing Services in these regions, from 2012 to 2022 (forecast), covering United States, EU, Japan, China, India & Southeast Asia and its Share (%) and CAGR for the forecasted period 2017 to 2022.
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Following would be the Chapters to display the Global Healthcare Analytical Testing Services market.
Chapter 1, to describe Definition, Specifications and Classification of Healthcare Analytical Testing Services, Applications of Healthcare Analytical Testing Services, Market Segment by Regions;
Chapter 2, to analyze the Manufacturing Cost Structure, Raw Material and Suppliers, Manufacturing Process, Industry Chain Structure;
Chapter 3, to display the Technical Data and Manufacturing Plants Analysis of Healthcare Analytical Testing Services, Capacity and Commercial Production Date, Manufacturing Plants Distribution, R&D Status and Technology Source, Raw Materials Sources Analysis;
Chapter 4, to show the Overall Market Analysis, Capacity Analysis (Company Segment), Sales Analysis (Company Segment), Sales Price Analysis (Company Segment);
Chapter 5 and 6, to show the Regional Market Analysis that includes United States, EU, Japan, China, India & Southeast Asia, Healthcare Analytical Testing Services Segment Market Analysis (by Type);
Chapter 7 and 8, to analyze the Healthcare Analytical Testing Services Segment Market Analysis (by Application) Major Manufacturers Analysis of Healthcare Analytical Testing Services;
Chapter 9, Market Trend Analysis, Regional Market Trend, Market Trend by Product Type [Method Validation, Environmental Monitoring, Bioanalytical Services, Stability & Microbial Testing], Market Trend by Application [Pharmaceutical];
Chapter 10, Regional Marketing Type Analysis, International Trade Type Analysis, Supply Chain Analysis;
Chapter 11, to analyze the Consumers Analysis of Global Healthcare Analytical Testing Services;
Chapter 12,13, 14 and 15, to describe Healthcare Analytical Testing Services sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.
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What this Research Study Offers:
Global Healthcare Analytical Testing Services Market share assessments for the regional and country level segments
Market share analysis of the top industry players
Strategic recommendations for the new entrants
Market forecasts for a minimum of 5 years of all the mentioned segments, sub segments and the regional markets
Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
Strategic recommendations in key business segments based on the market estimations
Competitive landscaping mapping the key common trends
Company profiling with detailed strategies, financials, and recent developments
Supply chain trends mapping the latest technological advancements
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Reasons for Buying this Report
This report provides pin-point analysis for changing competitive dynamics
It provides a forward looking perspective on different factors driving or restraining market growth
It provides a six-year forecast assessed on the basis of how the market is predicted to grow
It helps in understanding the key product segments and their future
It provides pin point analysis of changing competition dynamics and keeps you ahead of competitors
It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments
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The US EPA monitors a variety of chemicals in water that may cause harm to humans or wildlife to minimize exposure. Method 625 was developed by the Office of Science and Technology in the Clean Water program to allow the monitoring of a large suite of semivolatile chemicals in wastewater for compliance with the National Pollution Discharge Elimination System (NPDES). NPDES is a system of permitting that defines the characteristics of water that is released into a waterway, defined by industrial category. The permitting levels are set depending on the waterway’s use. If the waterway is used for recreation or is an important wildlife habitat, the limit may be set lower.
The original method was developed in the early 1980s and has been updated several times since then to allow the use of more modern technology. The latest update has taken place over the last few years and was proposed in a Method Update Rule (MUR) in 2015 which was just published in the Federal Register August 28, 2017 and became effective September 27, 2017 (1). The latest version of the method includes a larger suite of analytes (up to 364) and an extensive set of labeled surrogates to better monitor the method performance throughout the sample preparation and analysis step.
This application note will present the data collected as part of the demonstration of disk solid phase extraction validation for US EPA method 625.1. Nine different wastewater matrices were evaluated and tested against the criteria listed in Table 6 of the method. Sample preparation was performed using the Atlantic® One-pass system, where the water sample is passed through a solid phase extraction (SPE) disk and carbon cartridge once, rather than twice with a pH change between loadings. Automation of the process was achieved using the SPE-DEX® 4790 system (superseded by SPE-DEX 5000). Table I shows the matrix spike and matrix spike duplicate results for a centralized waste treatment point source (437 NPDES category) sample, for selected compounds. The spike recovery and agreement between the duplicates was within criteria for most all analytes. Method detection limits, initial demonstration of compliance, and other wastewater matrices are shown in the full application note (2).
(1) Method 625.1, December 14 revision, can be found in the MUR, February 19, 2015. Or downloaded here: https://ift.tt/2H7E83n
(2) Application Note 117, “Validation of Horizon Technology Disk Extraction Technology for US EPA Wastewater Method 625.1,” available from www.horizontechinc.com.
Horizon Technology, Inc.
16 Northwestern Drive, Salem, NH 03079
tel. (603) 893-3663
Website: www.horizontechinc.com
Healthcare Analytical Testing Services Market Report added by DecisionDatabases.com offers industry size, share, growth, trends and forecast analysis upto 2024. Healthcare Analytical Testing Services Market Report also covers top key players, porter’s five forces analysis and market segmentation in detail. The global healthcare analytical testing services market research report provides detailed information about the industry based on the revenue (USD MN) for the forecast period. This research study is a descriptive analysis of the healthcare analytical testing services market emphasizing the market drivers and restraints that govern the overall market growth. The trends and future prospects for the market are also included in the report which gives an intellectual understanding of the healthcare analytical testing services industry. Furthermore, the report quantifies the market share held by the major players of the industry and provides an in-depth view of the competitive landscape. The healthcare analytical testing services market is classified into different segments with detailed analysis of each with respect to geography for the study period.
The major market drivers are nutraceutical industry rising demand and growing recognition of the QBD (quality by design) approach in pharma research/manufacturing. The market growth might be restricted due pricing competition faced by major player and inadequate of expertise under the study period.
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The report offers a value chain analysis that gives a comprehensive outlook of the healthcare analytical testing services market. The attractiveness analysis of healthcare analytical testing services market has also been included so as to evaluate the segments that are anticipated to be profitable during the forecast period.
The healthcare analytical testing services market has been segmented based on types such as bioanalytical testing services, physical characterization services, method validation, raw material testing, batch release testing services, stability testing, microbial testing and environmental monitoring. The study incorporates periodic market estimates and forecasts. Each type has been analyzed based on the market size at regional and country levels.
The healthcare analytical testing services market has been segmented based on sample such as raw materials, finished products, in-process samples and environmental samples. The study incorporates periodic market estimates and forecasts. Each sample has been analyzed based on the market size at regional and country levels.
The healthcare analytical testing services market has been segmented based on end user such as pharmaceutical and biopharmaceutical companies, medical device companies and contract research organizations. The report provides forecast and estimates for each end user in terms of market size during the study period. Each end user has been further analyzed based on regional and country levels.
Major Table Of Contents:
1. 1. Introduction To The Healthcare Analytical Testing Services Market
2. Executive Summary
3. Market Analysis Of Healthcare Analytical Testing Services
4. Healthcare Analytical Testing Services Market Analysis By Type
5. Healthcare Analytical Testing Services Market Analysis By Sample
6. Healthcare Analytical Testing Services Market Analysis By End User
7. Healthcare Analytical Testing Services Market Analysis By Geography
8. Competitive Landscape Of Healthcare Analytical Testing Services Companies
9. Company Profiles Of Healthcare Analytical Testing Services Industry
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Geographically, the healthcare analytical testing services market has been segmented into regions such as North America, Europe, Asia Pacific and Rest of the World. The study details country-level aspects based on each segment and gives estimates in terms of market size.
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