With its new FDA approval for Upneeq, Osmotica Pharmaceuticals faces the task of marketing a reformulated nasal spray to millions of people with droopy eyelid, many of whom don't even know it's considered a disorder, much less a treatable one.
And not only that—it'll be trying to do that during a pandemic, and with a business model that's far from typical. Osmotica will start selling the drug directly to patients next month, bypassing wholesalers and pharmacies as it partners with a cadre of high-subscribing eye doctors to help build enthusiasm for the treatment.
An eye drop with the same active ingredient as nasal spray Afrin, oxymetazoline hydrochloride, Upneeq won its FDA green light last week as a first-ever treatment for adults with acquired blepharoptosis, or droopy eyelid. Oxymetazoline is an alpha adrenoceptor agonist believed to target Mueller's muscle, which raises the upper eyelid.
Until now, ptosis patients have had two treatment options: surgery or off-label use of other eye medications. Osmotica believes there are millions of eligible patients in the U.S. alone, many still undiagnosed. Aside from common complaints about the cosmetic effect, patients suffer from a more limited field of vision. Risk of developing the condition spikes with age, and eye surgeries for conditions such as glaucoma and cataracts can also trigger it.
The FDA approval was based on two phase 3 trials. In Osmotica's initial, 140-participant study, Upneeq patients saw bigger improvements in vision than placebo patients did, as measured by the Leicester Peripheral Field Test, a standard assessment of visual range. Reported side effects were minimal, with dry eye making up the bulk of patient reactions.
To get its direct-to-patient sales going, Osmotica has set up a new subsidiary, SVL Pharmaceuticals, and targeted 650 high-prescribing eye doctors for the initial rollout, management said during a Thursday conference call. Despite the pandemic, the 80-person sales team will call on the eye specialists in person as the company aims to expand the group to 2,500 or so by year-end.
To get the ball rolling, the company will offer a 15-day trial supply of Upneeq, bundled with literature on the condition and drug in eye clinics tapped for the initial rollout. Osmotica's also planning a patient awareness campaign to potentially push those who are undiagnosed—or who've decided against surgery—to check out Upneeq.
Current pricing plans peg a 30-day course at $90 to $120, or about $3 to $4 for each daily dose, and the company will offer a 25% to 35% discount to customers who opt in for a three-month supply. With Upneeq, there's no limit to duration of treatment, unlike oxymetazoline-based nasal decongestants, the company said.
Osmotica declined to make any firm sales projections. Given the drug's potential as an aesthetic product, however, Jefferies analysts think Upneeq's peak sales could eclipse its previous estimate of $250 million. Plus, Upneeq's appeal as a nonsurgical option during the pandemic, when patients may not be able to schedule elective procedures, could drive sales despite COVID-19, Jefferies and SVB Leerink analysts said.
The company is also on the hunt for a marketing partner outside the U.S. CEO Brian Markison said Osmotica is edging closer to a deal, but wouldn't offer more details.