Allergan’s decision to purchase dry eye device company Oculeve last year has been neatly repaid by success in two pivotal trials of the intranasal neurostimulation technology it acquired in the deal. An FDA filing is expected this year.
With its bestselling dry eye drug Restasis forecast to come under threat from Shire’s lifitegrast Allergan has been working hard to retain its dominance in this area, and the group ought to start to see a return on its $125m outlay for Oculeve fairly soon. Just how much of a return depends on how many patients can be persuaded to stick a neurostimulator up their nose several times a day.
The Oculeve product, also known as OD-01, is a hand-held device that is inserted into the nostril to electrically stimulate the nerves serving the lacrimal gland, causing the patient to produce tears. Stimulating a patient to produce natural tears is better than having them use eye drops, the company says, as drops can have safety issues resulting from the potential contact between the tear bottle and the ocular surface.
The two trials OCUN-009 and -010, assessed the ability of the Oculeve device to increase tear production in acute and chronic settings, respectively.
In OCUN-009, 48 patients used the handheld neurostimulator intranasally, as it is intended to be used. As controls, the same patients used the same device extranasally, and separately used an intranasal sham device. The patients were divided into six groups, each of which used the treatment and the two controls in a different order over the course of a single day.
Allergan says the trial met its primary endpoint, with the Oculeve product increasing tear production over baseline during intranasal treatment, as measured by Schirmer score, compared with both controls.
The OCUN-010 study was much longer term, with 97 patients using the device for six months. The primary efficacy endpoint, increase from baseline in tear production at day 180, as measured by Schirmer score, was met. Secondary endpoints of increase from baseline in tear production at days 0, 7, 30 and 90 were also met.
All device-related adverse events were mild, Allergan said, and no patients discontinued treatment due to side-effects.
The company will submit a PMA application to the FDA in the second half, meaning that approval could come some time in 2017.
Citi analysts say that while there is a market for alternatives to eye drops – both artificial tears and Allergan’s Restasis, which works by stimulating tear production pharmacologically – it is unclear how the device will fit into the changing dry eye treatment landscape.
One possibility is that the device could be used as an induction therapy for Restasis among treatment-naïve patients. Currently steroids are used off-label, but long-term or intermittent use is limited as they can increase intraocular pressure.
If the neurostimulator is approved, patient acceptance seems likely to be the main barrier to adoption. Allergan did not spend a fortune on Oculeve; at $125m the deal was worth just 0.1% of Allergan’s market cap at the time (Allergan stimulates pipeline with two deals in two days, July 7, 2015). Even so, it will want something to show for it, and with positive clinical data under its belt its task is now one of persuasion.
|Trial name||Design||Trial ID|
|OCUN-009||48 patients, one-day trial, two controls||NCT02680158|
|OCUN-010||97 patients, six-month trial, no control||NCT02526290|