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April 14, 2013

Compounding Pharmacy Safety

The recent voluntary recall of Avastin and other sterile products by Clinical Specialties, a compounding pharmacy in Georgia, serves as a reminder that assurance of sterile conditions is essential when utilizing the services of such a pharmacy. Jim Rehovsky, R.Ph.,Vice President, Ophthalmology and ASC for Avella Specialty Pharmacy, a leader in the arena of compounding pharmacies, said, "The industry-leading accreditation board, PCAB (Pharmacy Compounding Accreditation Board) is paramount to assuring healthcare providers and patients that the pharmacy they choose is committed to compounding quality. Selecting a PCAB-accredited pharmacy establishes confidence that staff are properly equipped, trained, and validated by an outside source to prepare sterile compounds." A further discussion on the topic of safety in compounding pharmacies can be found in the March 2013 issue of Retinal Physician¹ which can be found here http://www.retinalphysician.com/articleviewer.aspx?articleID=108035 ¹ Lenier S, How an Outbreak Changed Compounding Pharmacies: The Ophthalmic Side Effects - Compounders, accrediting agencies, regulators, and doctors have revisited their practices. Retinal Physician, March 2013.

Radiation Therapy for AMD

Three companies have been developing methods of treating Age-related Macular Degeneration (AMD) with radiation. One of those companies, NeoVista, has recently ceased operations, after failing to meet their primary endpoint in top-line results of both the CABERNET and MERLOT trials. NeoVista had been using an internal radiation approach of epiretinal brachytherapy. Oraya Therapeutics uses an external approach of stereotactic radiotherapy, utilizing a precisely targeted, low-dose x-ray as its radiation source. The therapy targets the fovea and monitors, manages, and tracks eye motion, so that if the eye moves out of position at any point during the therapy, the treatment basically shuts off until it can be realigned. One thing that is suspected to have been problematic in the NeoVista approach was getting the precise dose of radiation to the proper place. According to Oraya's CEO Jim Taylor, the Oraya method doesn't have that limitation. He said, "We use a robotic source delivery externally, precisely because we needed to be very certain about the distance from the source to the target, and we have a beam shape in three dimensions that actually provides for some patient and lesion variability." He also pointed out that by using a non-invasive, non-surgical approach, they're able to avoid complications of cataract formation, and reducing the half-life of drugs used in potential future injections due to removal of vitreous in the eye. Oraya is now initiating commercial sites and treatments in the U.K. and Switzerland, and further expansion in Europe is planned for later in 2013. Oraya's website can be found at http://www.orayainc.com/. Salutaris Medical Devices, Inc., is developing a minimally invasive procedure that can be performed in an outpatient or physician office setting in approximately 15 minutes. Their technology delivers a single-use brachytherapy procedure that can be performed in conjunction with standard anti-VEGF therapy. This technology uses a sub-Tenon episcleral approach to delivering brachytherapy that avoids the need for vitreous surgery, and the intraocular space is never violated. The application of radiation is delivered extraocularly, and the episcleral placement allows for consistent, stable and repeatable control of the distance to the target tissue, the choroidal neovascular lesion. Utilizing this minimally invasive technology, the retina specialist can deliver precise, lesion-specific, localized tissue treatment. More information about Salutaris Medical Devices, Inc. can be found at www.SalutarisMD.com.

Biomechanics of Retinal Detachment

Researchers in Sweden have published an article in which they describe developing a method to study the biomechanical aspects of eye diseases such as retinal detachment.¹ Using an animal model they were able to study a stretched retinal explant compared to non-stretched, and conclude that their results "confirm that biomechanical tension is a vital factor in the maintenance of retinal tissue integrity." The abstract for the recently published article can be found here. http://www.iovs.org/content/54/3/1845.abstract ¹ Taylor L, Moran D, Arner K, Warrant E, Ghosh F. Stretch to See: Lateral Tension Strongly Determines Cell Survival in Long-Term Cultures of Adult Porcine Retina. Investigative Ophthalmology & Visual Science, 2013; 54 (3): 1845 DOI: 10.1167/iovs.12-11420

Retina Does Well in NEI Challenge

The field of retina is well represented among the winners of the National Eye Institute's Challenge to Identify Audacious Goals in Vision Research and Blindness. The challenge was designed to "stimulate innovation in establishing a national vision research agenda", according to the NEI website. Of the ten winners chosen, the following four have retina-specific applications: Rajesh Rao, Washington Univ. School of Medicine in St. Louis and The Retina Institute, St. Louis, MO An Audacious Goal: Reprogramming the Retina - To directly reprogram easy-to-isolate skin or blood cells to retinal cells using gene therapy and other techniques to enable repair strategies for degenerative retinal diseases. Jeffrey Stern, Capital Region Retina, PLLC, Albany, NY Endogenous Retinal Repair: Releasing our Inner Salamander - To repair the retina by activating stem cells residing within the eye, awakening reparative processes that occur naturally in amphibians and other animals but which lay dormant in human patients. Russell Van Gelder, University of Washington, Seattle, WA Reversing Retinal Blindness Using Small Molecules - To restore vision to patients with retinal diseases through the use of a photoswitch, a small molecule that is chemically modified to become active or inactive after exposure to certain wavelengths of light. Dennis Clegg, University of California, Santa Barbara, CA Regenerative Therapy for Retinal Disease - To treat degenerative retinal disease with an off-the-shelf tissue graft that could be implanted in the back of the eye to replace cells lost to disease. A complete list of winners can be found at http://www.nei.nih.gov/challenge/

Industry Info

Bausch & Lomb has announced changes to their RETISERT^® implant. According to an email the company sent out, "the suture tab, which was previously made of polyvinyl alcohol (PVA), is now made of silicone elastomer, resulting in a silicone-to-silicone bond. Additionally, this new suture tab contains embedded mesh for added strength." The email also states that this change does not affect the handling of the product, or the surgical procedure required to implant it. More information about RETISERT^® can be found at http://www.retisert.com. Quantel Medical has received FDA approval for their new Vitra Multispot™ 532nm Pattern Scanning Laser, which was designed specifically for PRP treatments. This laser system combines advanced pattern scanning and solid-state green laser technologies in a compact portable platform. Quantel Medical's website can be found at www.quantel-medical.com.

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