John Saharek is the president of ImprimisRx, a wholly owned subsidiary of Harrow Health based in Carlsbad, Calif. The company is an ophthalmic-focused pharmaceutical business that is expanding its portfolio with segment-specific branded products. Mr. Saharek has more than 30 years of experience working in the health-care industry, including the last 20 years focused in the ophthalmic segment.

Ophthalmology Management: Why did you decide to add branded pharmaceuticals to the ImprimisRx portfolio?

John Saharek: We entered the market in 2014 with affordable, high-quality compounded pharmaceuticals but never believed that compounding would be where we would stop. Last year, we began to sell DEXYCU and prescription Avenova, and in the last 7 months, we have acquired AMP-100, MAQ-100 and four branded products from Novartis. These products will all be made available from our expanding New Jersey operation, including our FDA-registered outsourcing and distribution facility and our mail-order pharmacy.

OM: Can you tell us more about the branded pharmaceuticals ImprimisRx has recently added for the US market?

JS: The most exciting addition to the ImprimisRx portfolio, AMP-100, was acquired from Sintetica S.A. in June 2021. AMP-100 is a patented topical intraoperative anesthetic pain medication that we believe will be a great product for use with the 4 million cataract procedures — and almost 6 million intravitreal injection procedures — performed annually in the United States. The NDA for AMP-100 was filed with the FDA in December 2021, and we hope to have an approved product by late 2022.

Additionally, we acquired, from Wakamoto Pharmaceuticals, MAQ-100, an injectable triamcinolone approved in Japan since 2010, for which we intend to seek US market approval. We plan to file the NDA for MAQ-100 during 2022, which would make it a 2023 product once approved.

Also, in December, Harrow Health acquired the exclusive US commercialization rights of four FDA-approved ophthalmic medicines from Novartis: IOPIDINE 1% and 0.5% (apraclonidine hydrochloride), MAXITROL (neomycin and polymyxin B sulfate and dexamethasone) 3.5mg/10,000 units/0.1% and MOXEZA 0.5% (moxifloxacin hydrochloride). ImprimisRx initially plans to sell, market and distribute these products through traditional channels.

In December 2021, ImprimisRx also took over the US sales and marketing activities for DEXYCU (dexamethasone intraocular suspension) 9%. This was a result of an expansion of an existing partnership that was formed with EyePoint Pharmaceuticals in 2020. DEXYCU currently has pass-through reimbursement through the end of 2022.

OM: How has ImprimisRx streamlined the ordering and delivery of products?

JS: The model we have built over the last 8 years — a company that can distribute directly to both doctors and patients using technology platforms that make it very simple to do business with us — has worked well for our customers. We produce drugs for hundreds of thousands of ophthalmic surgical procedures each month. In addition, we help tens of thousands of patients with chronic therapies every month.

ImprimisRx dispenses its products from our 503B FDA-registered outsourcing facility (which allows us to send products in bulk shipments to ASCs, hospitals and clinics) and our 503A patient-specific pharmacy that serves thousands of ophthalmic health-care professionals and their patients every month.

OM: How has COVID-19 impacted your business?

JS: COVID-19 had a serious impact on the business from mid-March 2020 until mid-June 2020 when many states were restricting elective procedures, which cataract and LASIK fall into. As states opened back up, we were able to bounce back quickly as ASCs started to reopen and never looked back. Last July was a record month for the company, and we have been breaking many records since that time with products shipped to all 50 states and Puerto Rico. OM