MacuSight, Inc. Appoints Gerald Wroblewski Vice President of Operations Move Adds Key Manufacturing Expertise as Company Broadly Advances Sirolimus Clinical Development
Published: Nov 06, 2008
UNION CITY, Calif., Nov. 6 /PRNewswire/ -- MacuSight(TM), a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today announced the appointment of Gerald Wroblewski as the company's vice president of operations. Mr. Wroblewski brings MacuSight critical operational expertise in the areas of manufacturing, product supply chain management, packaging and quality assurance. At MacuSight, he will be responsible for overseeing functions related to each of these areas of expertise to support the company's broad Phase 2 clinical development program for its lead drug candidate, sirolimus. MacuSight is currently developing its proprietary sirolimus product for the treatment of diabetic macular edema (DME), wet age-related macular degeneration (wet AMD), and other target ophthalmic indications.
Prior to joining MacuSight, Mr. Wroblewski served as chief operating officer at iScience Interventional Inc., a start-up medical device company in the ophthalmology space. Responsible for manufacturing, quality assurance and regulatory activities, he is credited with establishing the company's operations organization to support internal commercial GMP manufacturing. From 2001-2004, Mr. Wroblewski also worked alongside many of the current MacuSight management team members at Oculex Pharmaceuticals, where he held the position of executive vice president of operations. While at Oculex, he was responsible for developing and implementing novel manufacturing systems designed to support the production of multiple product components related to the company's lead drug candidate. These innovative manufacturing platforms supported the advancement of the product into late-stage clinical trials and assisted in positioning Oculex for its subsequent acquisition by Allergan, Inc.
"Recent corporate developments including the initiation of our comprehensive Phase 2 development program for sirolimus and the previously announced collaboration with Santen Pharmaceutical Co., Ltd. have highlighted MacuSight's considerable progress over the past year. This corporate evolution has brought about the need to add management expertise that is appropriate for our advancing stage of development," stated David A. Weber, Ph.D., president and chief executive officer of MacuSight. "We are fortunate to have brought aboard an individual with Jerry's breadth of relevant experience in the important areas of manufacturing, product supply chain management and quality assurance. Having worked alongside Jerry previously, I know that his contributions at MacuSight will help solidify our manufacturing capability to ensure that all facets of our sirolimus development program are strong as we continue to advance this important drug candidate toward the market."
During his career, Mr. Wroblewski has also held senior management positions with Corgentech, The Gillette Company, Oral-B Laboratories and McGaw Laboratories. Additionally, he has acted as an operations consultant to Carl Zeiss Meditec and Carl Zeiss Surgical, assisting in integrating the two business units following their merger.
"In deciding to join the MacuSight team, I was particularly impressed with the company's breadth of talent and leadership, as well as the significant progress that has been achieved with regard to the sirolimus program," said Mr. Wroblewski. "I am excited by the opportunity to offer MacuSight my manufacturing and quality assurance expertise in order to establish a commercially viable and cost-effective product supply to support the ongoing clinical development and ultimate commercialization of sirolimus."
About Sirolimus Development Program
MacuSight is currently conducting a Phase 2 clinical trial of sirolimus in patients with diabetic macular edema (DME). Known as the DIAMOND trial, this placebo-controlled, dose-ranging study is expected to enroll 120 patients. Being conducted at approximately 50 U.S. investigational sites, the study consists of four treatment arms (three different sirolimus doses administered with subconjunctival injection and placebo).
In addition to the DIAMOND trial, MacuSight is presently initiating Phase 2 studies of sirolimus in wet age-related macular degeneration (wet AMD). This portion of the development program consists of two separate studies -- one with sirolimus as a monotherapy and one with the compound as part of a combination therapy. Furthermore, sirolimus' broad biological activities provide MacuSight with the opportunity to explore a role for the compound in additional ophthalmic areas of need. Accordingly, the company also plans to study sirolimus for indications such as dry eye and non-exudative age-related macular degeneration (i.e., dry AMD).
MacuSight has completed two Phase 1 clinical trials of its sirolimus product candidate in patients with wet AMD and DME. Findings from both studies demonstrated the product to be safe and well-tolerated in all doses tested with two different routes of administration (subconjunctival injection and intravitreal injection). In addition, investigators from both studies noted improvements in visual acuity consistent with anatomical changes following a single administration of sirolimus. Importantly, these findings were similar for patients receiving sirolimus via either intravitreal injections or less-invasive, more convenient subconjunctival injections. These promising results for sirolimus delivered with subconjunctival injection provide the first evidence for the potential of treating retinal disease without direct injection into the back of the eye.
MacuSight is a privately-held pharmaceutical company focused on developing innovative therapeutics for the treatment of severe ocular diseases and conditions. The company is dedicated to preserving patients' vision by identifying known, highly-potent and broad-acting small molecule drug compounds that may possess efficacy in treating and/or preventing diseases or conditions of the eye. As part of its unique product development philosophy, MacuSight also concentrates on the optimal delivery of these compounds into the eye. By combining its compounds with innovative delivery approaches, the company strives to optimize the efficacy, safety, convenience and cost-effectiveness of its product candidates.
The company's lead development program is centered on advancing sirolimus (rapamycin) as a potential next-generation therapeutic for the treatment of diabetic macular edema (DME), a manifestation of diabetic retinopathy, and the treatment and prevention of wet age-related macular degeneration (wet AMD).
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