News Article | May 8, 2017
BEDFORD, Mass.--(BUSINESS WIRE)--Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye, presented yesterday new data from its most recent Phase 3 study evaluating the safety and efficacy of DEXTENZA (dexamethasone insert) 0.4 mg for the treatment of ocular pain and inflammation following cataract surgery. The data were released at the American Society of Cataract and Refractive Surgery Annual Symposium (ASCRS) in Los Angeles, CA. The U.S. Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017 for a decision regarding the potential approval of DEXTENZA for the treatment of ocular pain following ophthalmic surgery. Primary endpoints included absence of anterior chamber (AC) cells (a sign of inflammation) at Day 14 and absence of pain at Day 8. Topical NSAIDs were not permitted. Both endpoints were statistically superior to placebo, with more than 52% of patients receiving DEXTENZA having no AC cells at Day 14 compared to 31.1% of placebo subjects. Additionally, 79% of patients in the DEXTENZA group reported no pain at Day 8 compared to 61.3% of the placebo group. Statistical superiority of DEXTENZA was also noticed at Day 2 for the absence of ocular pain and Day 4 for the absence of AC cells. There were no treatment-related serious adverse events (SAEs) and DEXTENZA was well tolerated in all clinical trials. No patients experienced any adverse events resulting in study withdrawal. A cross-sectional, qualitative survey, commissioned by Ocular Therapeutix, evaluating patient experience of DEXTENZA among 25 patients from U.S. Phase 3 investigational clinical trials was also presented at the ASCRS meeting. In the survey, 92% of patients reported the highest level of overall satisfaction with the product, and would recommend DEXTENZA to family and friends. Further, 96% of patients reported the highest level of satisfaction with regard to convenience. Additionally, 84% of patients reported that they would be willing to pay more for DEXTENZA and would request DEXTENZA again. “DEXTENZA’s safety and efficacy profile, combined with a positive patient experience, provide a strong foundation for offering an alternative to current post-operative steroid eye drops, which are associated with compliance issues,” said Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman of Ocular Therapeutix. “If approved, DEXTENZA may reduce the patient burden of administering topical eye drops following ophthalmic surgery by enabling physicians to control the entire course of steroid therapy with a single administration.” The Company also presented data on the importance of pain assessment following ophthalmic surgery; preservatives in topical ophthalmic medications used after ocular surgery; a literature review on medical adherence for glaucoma; and the evaluation of a Phase 3 clinical development program for OTX-TP, a sustained release travoprost intracanalicular insert for the treatment of glaucoma and ocular hypertension. This prospective, multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled study was designed to evaluate the safety and efficacy of DEXTENZA for the treatment of ocular inflammation and pain following cataract surgery. The study enrolled 438 patients who were undergoing clear corneal cataract surgery at 21 sites throughout the United States. Immediately following surgery, patients were randomized to insertion of either DEXTENZA or a placebo vehicle. Primary efficacy endpoints evaluated the differences between the DEXTENZA treatment group and the placebo group for the absence of anterior chamber cells at day 14 and absence of pain at day 8. Secondary efficacy endpoints included absence of anterior chamber cells, absence of ocular flare, and absence of ocular pain across relevant time points during the 30-day treatment period. About DEXTENZA™ (dexamethasone insert) 0.4 mg for Intracanalicular Use DEXTENZA is placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal. The Company has completed three Phase 3 clinical trials with DEXTENZA for the treatment of post-surgical ocular inflammation and pain. Ocular Therapeutix resubmitted an NDA to the FDA for DEXTENZA for the treatment of ocular pain following ophthalmic surgery, for which the FDA has set a PDUFA target action date of July 19, 2017. Subject to the approval of the NDA for post-surgical ocular pain by the FDA, Ocular Therapeutix intends to submit a supplement to its NDA for DEXTENZA to broaden its label to include a post-surgical ocular inflammation indication. About Ocular Pain and Inflammation Following Ophthalmic Surgery Ocular pain and inflammation are common side effects following ophthalmic surgery. Physicians prescribe topical corticosteroids as part of the standard of post-operative care. If left untreated, inflammation of the eye may result in further ocular complications, which in some cases may cause permanent loss of vision. According to US Census data, by the year 2020 it is estimated that the number of Americans diagnosed with cataracts is expected to rise to approximately 30 million, representing a 32% increase over current prevalence estimates. According to Market Scope, approximately 3.9 million cataract cases and over 5.6 million ocular surgeries were performed in the United States in 2016. Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidate, DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular use has completed Phase 3 clinical development for the treatment of ocular pain and inflammation following ophthalmic surgery. The FDA has accepted the Company’s NDA resubmission for DEXTENZA for the treatment of ocular pain following ophthalmic surgery and has established a PDUFA target action date of July 19, 2017. If approved, the Company intends to submit a supplement to its NDA for ocular inflammation. OTX-TP (travoprost insert) is in Phase 3 clinical development for glaucoma and ocular hypertension. Ocular Therapeutix is also evaluating injectable drug delivery depots for back-of-the-eye diseases. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery. Any statements in this press release about future expectations, plans and prospects for the Company including the development and regulatory status of the Company’s product candidates, such as the Company’s expectations and plans regarding regulatory submissions for and the timing and conduct of clinical trials of DEXTENZA™ for the treatment of post-surgical ocular inflammation and pain, including our expectations regarding the NDA filed with the FDA and the FDA’s response to the resubmitted NDA and the potential impact of the re-inspection of manufacturing operations, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the treatment of dry eye disease and OTX-TP for the treatment of glaucoma and ocular hypertension, the ongoing development of the Company’s sustained release hydrogel technology, the potential utility of any of the Company’s product candidates, potential commercialization of the Company’s product candidates, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing ReSure® Sealant or any product candidate that receives regulatory approval, the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release. Educational content of the ASCRS•ASOA Annual Symposium & Congress is planned by its program committee, and ASCRS•ASOA does not endorse, promote, approve, or recommend the use of any products, devices, or services.
News Article | May 4, 2017
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Compulink Business Systems, Inc., a recognized leader in Enterprise EHR and Practice Management for ophthalmology, will present the latest enhancements to its Ophthalmology Advantage™ system to address value-based care at the ASCRS ♦ ASOA Symposium & Congress this week. Compulink is committed to providing ophthalmic solutions and services that help providers improve efficiency and increase revenue. Innovations being showcased at ASCRS include: “In the new age of MIPS and value-based care, our mission continues to be to offer comprehensive solutions and services to take away all unnecessary work and allow providers to focus on patient care and growing their business,” said Link Wilson, CEO and founder of Compulink. Attendees at ASCRS 2017 can demo Ophthalmology Advantage at booth #953 from May 6-8 in Los Angeles, CA. A proven partner for 32 years, Compulink is a leader in specialty specific EHR and Practice Management solutions. We provide everything you need to deliver value-based care and achieve financial success. For more information, visit www.compulinkadvantage.com.
News Article | May 4, 2017
Industry-leading medical exam and procedure equipment manufacturer Reliance Medical Products announced today the launch of its completely redesigned Premiere Collection 7000 and 710 Exam and Procedure Chairs for ophthalmic and ENT practices. Available in four new color themes or 16 different customizable color combinations, these chairs bring modern, stylish design to the exam room. Inspired by the latest trends in retail and spa design, the Premiere Collection’s new color themes – Lucent, Woodland, Harmony, and Industrial – were created to complement, or even inspire, any contemporary interior aesthetic. These new color options will be on display at ASCRS•ASOA 2017 in Los Angeles. “In today’s retail environment, every eye care professional’s office should be something to see – from the front office all the way through the exam lane,” says Chris Blizzard, Director of Sales and Product Marketing at Reliance. “With our Premiere Collection, practices can get chairs that blend fashion with the form and function we’ve always been known for, and help you stand out from waiting room to exam room.” Reliance 7000 and 710 Exam and Procedure Chairs help create a heightened patient experience, attract and retain customers, and generate referrals. In addition to sleek design, the chairs are durable, comfortable, and allow for convenient movements and functionality during procedure. Choose a preselected theme, or select your own two- or three-tone palette for a look unique to your practice. Visit Reliance Medical Products booth #2013 to see these new chairs for yourself. The ASCRS•ASOA Symposium and Congress is held May 5-9. You can register for the Symposium and Congress by visiting http://annualmeeting.ascrs.org/registration. For more information about Reliance Medical Products or the Premiere Collection, contact Chris Blizzard at cblizzard(at)reliance-medical(dot)com or visit http://builttosupport.com/premiere. ABOUT RELIANCE MEDICAL PRODUCTS Reliance Medical Products is the manufacturer of high-quality exam and procedure chairs, surgical stools, instrument delivery systems, treatment cabinets and room lighting systems for ophthalmic and ENT medical practices. Reliance products are made in the USA and sell in over 80 countries. Our design, engineering, manufacturing, and service teams are located with Haag-Streit USA in Mason, Ohio. As a world leader in ergonomic and high-value equipment, we deliver the most rugged chairs, stools, stands, and lighting systems on the market. Visit http://builttosupport.com.
News Article | May 4, 2017
Simple Drops™ preservative-free drops conveniently provide multiple glaucoma medications into a single bottle providing patients with a simple treatment option. By providing multiple medications into one combination drop, Simple Drops™ may increase patient compliance and reduce costs. Each formulation is provided in a uniquely-designed bottle with PureFlow® technology, which allows for a one-way valve system preventing the risk of contamination. Simple Drops™ consist of high-quality sterile FDA-approved components that are made and dispensed from Imprimis' PCAB-accredited and FDA-inspected facilities. Ordering Simple Drops is easy through the online MaxRx Prescriber Portal today here. Simple Drops preservative-free drops are more than just glaucoma medications. Many glaucoma patients have difficulties adhering to their treatment and one primary cause is the requirement to administer multiple daily drops with various dosing regimens. Under the Glaucoma Care Program™, patients will receive coaching to help manage their conditions. They will also have immediate access to trained consultative pharmacists, resources to better understand their condition, receive a subscription to the monthly e-newsletter, Glaucoma Review, and the right tools to comply with treatment recommendations. Attendees are invited to attend Imprimis' in-booth (#3038) presentations featuring Imprimis' new Simple Drops™ preservative-free drops, as well as Dropless Cataract Surgery®, LessDrops® combination drop therapy, and IV Free™ Cataract Surgery. Details of the events are available online and listed below: All educational content of the ASCRS•ASOA Annual Symposium & Congress is planned by its program committee, and ASCRS•ASOA does not endorse, promote, approve, or recommend the use of any products, devices or services. Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a pharmaceutical company dedicated to producing and dispensing high quality innovative medications in all 50 states. The company's unique business model increases patient access and affordability to many critical medicines. Headquartered in San Diego, California, Imprimis owns and operates three production and dispensing facilities located in California, New Jersey and Pennsylvania. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com. This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Other than drugs compounded at a registered outsourcing facility, all Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/imprimis-pharmaceuticals-to-launch-its-simple-drops-combination-glaucoma-drops-at-leading-cataract--refractive-surgery-medical-meeting-300451252.html
News Article | May 4, 2017
DALLAS, TX--(Marketwired - May 4, 2017) - Refocus Group, a pioneer in vision-correcting technology, announced today that it has successfully completed its 12-month follow-up on 360 patients in its pivotal trial of the VisAbility™ Micro-Insert System for presbyopia. The announcement paves the way for preparation of Refocus Group's Pre-Market Approval submission to the U.S. Food and Drug Administration (FDA). The VisAbility™ Micro-Insert System is the first and only presbyopic procedure performed outside the eyes' line-of-sight, developed to restore near vision without any compromise to distance vision or depth perception, a potential drawback of other presbyopic treatments. Because the procedure is performed in the sclera (white of the eye), the VisAbility™ Micro-Insert System does not alter the cornea or natural lens, so the eye is preserved for future refractive or cataract procedures. "An early sample of consecutive cases treated by me and one other investigator (a total of 40 eyes of 20 subjects) showed that 100 percent of eyes had uncorrected near visual acuity of J3 (20/40) or better, 95 percent were J2 (20/30) or better, and 90 percent were J1 (20/25) or better, with no change in their distance vision at 12 months," said Frank A. Bucci, Jr., MD, founder, Bucci Laser Vision Institute, Wilkes Barre, Pa. "My patients have been very satisfied with the range and quality of their vision, so I believe the VisAbility™ Procedure will be a valuable addition to our presbyopia correction armamentarium." Study investigators will present their initial findings at sessions during the ASCRS ASOA Symposium & Congress held by the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators at the Los Angeles Convention Center, 1201 S. Figueroa St., Los Angeles, Calif., May 5-9, 2017. One session, to be held as part of the new Industry Spotlight Theater, will include the VisAbility™ Micro-Insert System during a panel discussion on Presbyopia Correction, Monday, May 8, from 11 a.m. to 12 noon. Nearly 90 million Americans, and 1.7 billion people worldwide, are affected by presbyopia. Presbyopia causes the inevitable loss of near vision after age 40, making it difficult to read, do hobby work or use a cell phone, without the aid of reading glasses. "The VisAbility™ Procedure doesn't stop the clock from ticking, but it can turn back the hands so Baby Boomers can see near, again," said Mike Judy, CEO of Refocus Group. "We've seen promising outcomes that have kept investigators intrigued as the technology has improved and the technique evolved. A Refocus patient survey from an early FDA developmental study showed that 90.3 percent of patients reported their near vision was better or significantly better since the procedure." The current clinical trial, "A Prospective, Multicenter Clinical Trial of The VisAbility™ Implant System for Improvement of Near Visual Acuity in Presbyopic Patients," enrolled a total of 360 subjects between 45 and 60 years of age, at 13 clinical sites in the U.S. Given the substantial previous clinical trial history and data on the device, the FDA granted Refocus Group a 12-month follow-up for submission, versus the usual 24 months. "It is so exciting to see a presbyopic alternative solution that does not involve visual compromise," reported Dr. Selene A. Burke, Vice President of Clinical Affairs at Refocus Group. "Since the VisAbility™ Micro-Insert does not alter the cornea or crystalline lens, I believe it will be viewed as a true game changer in the treatment of presbyopia." The VisAbility™ Procedure is performed on both eyes and consists of inserting four, micro-thin inserts, smaller than a grain of rice, just below the surface of the sclera. The inserts are designed to restore the eye's natural ability to bring near vision back into focus. The inserts are so small they can't be felt, and are unnoticeable to others in normal gaze. The VisAbility™ Micro-Insert System is performed as an outpatient procedure with topical (eye drop) anesthesia. About Refocus Group Inc. Refocus Group Inc. is a pioneer in vision-correcting technology and is the developer of the VisAbility™ Micro-Insert System, an investigational medical device currently undergoing clinical trials in the United States, that may be able to restore the natural ability to focus on objects up close and eliminate the need for reading glasses. The company is headquartered in Dallas.
Iskenderov D.A.,AZNEFT |
Mustafayev S.D.,ASOA |
SOCAR Proceedings | Year: 2014
The article deals with the study of steady-state research. Oilwells sucker-rod pumps at wells No54, No36 and No417 at Kalmas, OGPD named after A.Amirov were studied. Well test-based crossplot of drawdown vs flow rate have been presented. The studies show availability of distinctions between flooded and water-free wells based on diagrams and their interpretation.
Feyzullayev Kh.A.,OilGasScientificResearchProject Institute |
SOCAR Proceedings | Year: 2014
The article considers the hydro dynamic modelling of gas condensate fields development depletion based on differential condensation of a condensate mixture. The proposed calculation method was to perform numerical experiments to demonstrate the role of the ethane-propane-butane fractions in interphase mass transfer processes.
Suleymanov A.A.,ASOA |
SOCAR Proceedings | Year: 2011
In the article the reliable determination of information collection which is used in oil and gas production modeling, it is proposed to apply a dynamic analysis of primary technological measures. Fundamental methodologies for evaluation of recovered volumes of hydrocarbons were introduced and applied during the analysis of results of laboratory experiments on displacement of oil from porous medium with water and by primary technological measures in the "Neft Dashlari" oilfield development. The approach developed permits the collection of reliable predicted values of recoverable volumes of hydrocarbons with consideration of transient processes in formation system and also to make reasoned decision in management and selection of strategy in oil and gas field development.
Salavatov T.S.,ASOA |
SOCAR Proceedings | Year: 2010
The applications of horizontal well technology in developing hydrocarbon reservoirs have been widely used in recent years. One of the main objectives of using this technology is to improve hydrocarbon recovery from water and/or gas-cap drive reservoirs. The advantages of using a horizontal well over a conventional vertical well are their larger capacity to produce oil at the same drawdown and a longer breakthrough time at a given production rate. Coning is a term used to describe the mechanism underlying the upward movement of water and/ or the down movement of gas into the perforations of a producing well. Coning can seriously impact the well productivity and influence the degree of depletion and the overall recovery efficiency of the oil reservoirs. Delaying the encroachment and production of gas and water are essentially the controlling factors in maximizing the field's ultimate oil recovery. Since coning can have an important influence on operations, recovery, and economics, it is the objective of this paper to develop a computer program for calculating the critical oil (or gas) rate to avoid coning of unwanted fluids into production wells and to predict the behavior of water and gas coning in horizontal wells.
SOCAR Proceedings | Year: 2012
The effectiveness of investment due to postponement of the implementation of oil production is evaluated given the time factor and price trends for the development and exploration of oil fields. More efficient use capital for oil field development can be obtained using a suitable delay for the implementation of investment projects.