Peer-Reviewed Study of Dropless Cataract Surgery Shows 'Measurable Benefits' Compared to Drops
Journal of Clinical Ophthalmology reports 'strong patient preference' for Imprimis Pharmaceuticals' Dropless Therapy® formulation
SAN DIEGO, July 22, 2016 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company dedicated to making drugs affordable again through its Branded Compounding™ business model, today announced that positive results of a clinical study comparing the efficacy of its injected triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (Tri-Moxi-Vanc) Dropless Therapy® formulation to drops commonly prescribed after cataract surgery now appear in the July issue of the Journal of Clinical Ophthalmology.
In this prospective, randomized, subject-masked contralateral eye study, 25 subjects with uncomplicated cataract received either Tri-Moxi-Vanc intraocular solution injected transzonularly into the vitreous or a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (Pred-Moxi-Ketor) for 1 week, followed by prednisolone acetate and ketorolac tromethamine (Pred-Ketor) for 2 to 4 weeks. Each patient received the opposite treatment for the second eye surgery. In the following month, Tri-Moxi-Vanc and drops produced no statistically significant difference in intraocular pressure immediately (P=0.81) or over time (P=0.74), central macular thickness at 1 week and 1 month (P=0.18), central corneal thickness (P=0.92), or reported pain (P=0.67). Both groups expressed similar satisfaction with surgery, but patients who received Tri-Moxi-Vanc preferred the overall experience (P=0.01).
"I have seen the measurable benefits of Dropless Cataract Surgery for my patients. This study takes the very important step of calculating those benefits," said lead author Bret L. Fisher, MD, of Eye Center of North Florida. "The results were very gratifying. We demonstrated in a carefully designed and controlled clinical trial that not only does Dropless Therapy produce results equivalent to drops, but it also earns a very strong patient preference over even the most convenient form of compounded eye drops available."
"The exciting results of this peer-reviewed study in the Journal of Clinical Ophthalmology reinforce the positive outcomes surgeons have reported in over 200,000 cataract procedures using Dropless Therapy," explained Mark L. Baum, CEO of Imprimis. "This is an important step toward advancing Dropless Cataract Surgery into the standard of care for millions of patients who undergo this surgery every year. Imprimis will continue to bolster adoption of this innovative ophthalmic pharmaceutical among surgeons who wish to improve the patient experience, eliminate their own concerns about compliance and reduce payer and out-of-pocket costs."
A recent study sponsored by Cataract Surgeons for Improved Eyecare (CSIE) (www.improvedeyecare.org) shows over the next 10 years, cataract surgery with Dropless Therapy could save more than more than $7 billion in Medicare and Medicaid costs, $1.4 billion in patient copayments and $124 million in state Medicaid payments. CSIE, a national membership association of ophthalmic peers who advocate for patient access to high-quality care, is currently petitioning for new CMS rules for Dropless Therapy reimbursement.
ABOUT IMPRIMIS' DROPLESS THERAPY
Imprimis' Dropless Therapy consists of compounded antibiotic and steroid formulations, Tri-Moxi and Tri-Moxi-Vanc, available in single, injectable intraocular doses administered by physicians following ocular surgery. Dropless Therapy may substantially reduce or eliminate the need for patient-administered eye drops following surgery, thereby largely eliminating patient non-compliance and dosing errors associated with post-operative care regiments. Dropless Therapy can simplify the post-operative care process, provide safeguards against bacterial infection and inflammation and decrease overall costs. The sterile ophthalmic formulations are enabled by the company's patent-pending SSP Technology®, which allows for active pharmaceutical ingredients that ordinarily do not mix to solubilize into a predictable, well-distributed, micronized particle suspension. The drug formulations are optimized for isotonicity and pH most compatible for ophthalmic use, either as injectable or topical therapies. Every batch is tested for sterility prior to distribution and a complimentary copy of the test report is included with each prescription. More information is available at www.GoDropless.com.
ABOUT IMPRIMIS PHARMACEUTICALS
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a pharmaceutical company dedicated to making drugs affordable again through its Branded Compounding™ business model. The company is focused on patient outcomes and affordability and offers high quality lower-cost custom compounded drugs in all 50 states. Headquartered in San Diego, California, Imprimis owns and operates four dispensing facilities located in California, Texas, New Jersey and Pennsylvania. For more information about Imprimis, please visit the corporate website at www.ImprimisPharma.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 its formulations; risks related to its 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 its formulations; our ability to obtain intellectual property protection for its assets; its ability to accurately estimate its 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 its 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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/peer-reviewed-study-of-dropless-cataract-surgery-shows-measurable-benefits-compared-to-drops-300302616.html
SOURCE Imprimis Pharmaceuticals, Inc.