Imprimis Pharmaceuticals has created subsidiary focused on dry eye disease. The offshoot, Surface Pharmaceuticals, plans to develop three formulations in ophthalmology indications fought over by companies including Allergan and Shire.
San Diego, California-based Imprimis is a pharmacy that provides proprietary compounded formulations. This line of work has led Imprimis to identify compounded drugs it thinks have a shot at winning approval under the FDA’s 505(b)(2) pathway and going on to claim market share. Surface is the manifestation of this thinking.
The spinoff starts life with three candidates and aspirations to develop them in five indications. One of the candidates, SURF-100, uses the immunosuppressant mycophenolic acid as its active ingredient. Another, SURF-200 or SURF-201 depending on the indication targeted, is based on the steroid betamethasone.
These two candidates both combine their active ingredients with Klarity, a topical ophthalmic gel or solution technology Imprimis picked up the rights to in April. Surface thinks combining Klarity with mycophenolic acid will result in a formulation capable of challenging Allergan’s Restasis and Shire’s Xiidra for the chronic dry eye disease market.
The betamethasone formulations are aimed at patients with episodic dry eye disease and post-cataract-surgery pain and inflammation.
Surface’s third candidate consists of low-dose doxycycline—a tetracycline antibiotic—and omega-3. The combination is based on the belief that omega-3 supplements may prevent symptoms of dry eye disease and that adding the fatty acids to the antibiotic sometimes used as second-line treatments of the disease may therefore improve outcomes.
The scientific and business rationales behind the candidates remain uncertain and unproven. But Surface thinks it can start to address some of the uncertainties relatively quickly and cheaply. The startup thinks it can have phase 2 data in all of the indications by the first half of 2020, with most of the readouts coming in 2019.
At $3.4 million to $5.5 million, the development of SURF-100 is forecast to be the biggest line item. Surface’s ability to make that investment rests on its ongoing fundraising efforts. Imprimis wants Surface to be funded outside of its operation. At the last count, the compounding pharmacy had $4.2 million in cash.
The creation of Surface comes four months after Imprimis’ first spinoff, Eton Pharmaceuticals, put together a $20 million series A.
Imprimis’ business development activities have taken place against a backdrop of difficulties for its core business. The FDA hit Imprimis with a warning letter in August after inspectors found fibrous material thought to be wood in a product compounded by the pharmacy. Inspectors also blasted Imprimis for having inadequate cleaning procedures and cross-contamination controls.
The FDA issued a separate warning in August after a patient died following administration of a curcumin emulsion compounded by Imprimis.
Shares in the company are down almost 40% over the past year.