According to the company, its announcement represents the first time eyecare professionals have been able to stock a fortified or high-concentration compounded antibiotic formulation for the immediate treatment of patients in need.
Harrow today announced the availability, for in-office use of tobramycin 1.5% + vancomycin 5% (Fortisite) from its FDA‑registered and FDA‑inspected ImprimisRx 503B outsourcing facility.
According to the company, tobramycin 1.5% + vancomycin 5% formulations are patent-pending high-concentration, refrigeration-stable, fortified antibiotic formulations, in solution. The company added in its news release that the availability of tobramycin 1.5% + vancomycin 5% for in-office use represents the first time eyecare professionals have been able to stock a fortified or high-concentration compounded antibiotic formulation for the immediate treatment of patients in need.
ImprimisRx offers a tobramycin 1.5% + vancomycin 5% patient access program and a 100% replacement guarantee for any expired 503B tobramycin 1.5% + vancomycin 5% product, ensuring all prescribing U.S. eyecare professionals can continuously stock tobramycin 1.5% + vancomycin 5% formulations in their offices.
“The availability of Fortisite formulations will provide eyecare professionals with new and important tools in their pharmaceutical armamentarium as they consider how to treat potentially sight-threatening infections,” said Mark L. Baum, chairman and CEO of Harrow. “Until there is an FDA-approved product to meet these needs, Fortisite formulations have the potential to become the standard of care for ophthalmology and optometry practices across the country.”
The company also noted that eyecare professionals can order tobramycin 1.5% + vancomycin 5% online or call ImprimisRx Customer Care at 1-844-446-6979.
“Because Fortisite is now available for in-office use from our FDA-registered 503B outsourcing facility, each bottle must strictly adhere to rigorous analytical testing protocols that are not required for locally regulated 503A compounding pharmacies,” Baum added.
Several ophthalmologists are spotlighting the importance of having fortified antibiotics readily available for the management of certain serious eye infections.
“Every ophthalmologist who has an anterior segment practice should have Fortisite available in their refrigerator for that ounce of protection you need on that Friday afternoon for that patient that comes in with infection that you say, ‘what do I do next?’” said Eric Donnenfeld, MD, clinical professor in the Department of Ophthalmology at New York University Grossman School of Medicine, New York, and founding partner of Ophthalmic Consultants of Long Island in Garden City, New York. “To have this available from Harrow’s ImprimisRx [division] is a really nice thing to have.”
Brian Shafer, MD, a cataract, refractive, cornea, and glaucoma surgeon with Chester County Eye Care, called the move a “game changer.”
The commercial availability of Fortisite is truly a game changer in the management of certain serious infectious eye diseases,” he said in the news release. “Gone are the days of sending patients to compounding pharmacies hours away. Now, we can provide patients with the care they need and deserve directly from the office refrigerator.”
Terrence P. O’Brien, MD, distinguished professor of ophthalmology at Bascom Palmer Eye Institute, pointed out in the news release that topical broad-spectrum ophthalmic antibacterial agents are a key therapy for severe, sight-threatening ocular infections.
‘Finally, a reliable source for stable, commercially available, shelf-ready potent formulations for immediate application is changing traditional access and reliability challenges while allowing more rapid achievement of microbicidal concentrations in ocular tissues for potentially enhancing treatment response,” he said.
Compounded medications are not reviewed by the FDA for safety or efficacy. ImprimisRx does not compound copies of commercially available products.