Investors have leapt at the chance to buy into two glaucoma stocks, Aerie Pharmaceuticals and Ocular Therapeutix, on clinical trial updates that can at best only be described as mixed.
Both traded up sharply yesterday on what was admittedly an up day, with the market apparently happy to overlook flaws in each company’s plan to get its respective glaucoma treatment to market. That said, the enthusiasm seemed to have been rewarded today when Novartis bought a private glaucoma device maker, showing that big pharma still has appetite for this space.
The Swiss firm’s interest centres on Transcend Medical, whose takeover it has effected via the Alcon unit, following in the footsteps of Allergan’s acquisition of the ocular stent developer AqueSys last year (Novartis hopes Transcend buy will relieve the pressure on Alcon, February 18, 2016).
Aerie and Ocular, meanwhile, are relative newcomers to this space, having completed IPOs in October 2013 and July 2014 respectively. Both have been punished heavily in the biotech market downturn of the past six months.
This is despite Aerie getting its act together with the glaucoma project Rhopressa: after this flunked the Rocket-1 study the efficacy endpoint in Rocket-2 was changed, and this second trial went on to read out positive (Aerie goes airborne as trial revision breeds win, September 17, 2015).
Now, apparently, comes more good news from Rocket-2, which in addition to hitting 30-day non-inferiority to generic timolol had to show safety at 12-months in at least 100 patients. After market close yesterday Aerie reported what it termed positive safety in the first 118 patients to complete 12 months’ treatment.
Aerie traded up 6% yesterday, and opened up another 19% this morning. However, on closer inspection the data actually seem to show a worrying increase in safety concerns, while efficacy is broadly maintained, versus that seen at 90 days.
Back in September Aerie reported eye redness as the main drawback in the Rhopressa arm of Rocket-2. Now, in addition to eye redness, come conunctival haemorrhage, corneal deposits, blurry vision and – perhaps most worryingly – loss of vision clarity; these adverse events occurred in 5-23% of patients.
This might all be acceptable as part of a risk/benefit profile that includes much improved efficacy; but all the Rhopressa clinical programme is demonstrating is that the project is no worse at lowering intraocular pressure (IOP) than timolol, a generic drug. Investors piling in today ignore the elephant in the room at their peril.
No such worries for Ocular, apparently, which surged 39% yesterday on news that its sustained-release travoprost, OTX-TP, would not even have to be compared against timolol in phase III. Instead a placebo arm would do, according to feedback from a meeting with the US FDA.
This might be great for raising the odds of a positive result, and indeed for potential approval – in the absence of adverse events – but it is unclear how Ocular might secure reimbursement for a drug that at the end of the day risks being seen as no better than a cheap generic.
Travoprost itself is already available generically. Meanwhile, Aerie is separately developing the active ingredient in Rhopressa, netarsudil mesylate, in combination with Pfizer’s Xalatan as Roclatan. Rhopressa is positioned for mild glaucoma (IOP of 20-25mmHg), while Roclatan is intended for patients with IOPs up to 36mmHg.
Aerie yesterday said filing Rhopressa was “on target” for the third quarter; it had previously targeted the mid-year, but investors seem happy for now to ignore this slippage.
|Rocket-2||756 glaucoma pts. 30-day efficacy read out Sep 2015. 12-mth safety data in 118 pts presented Feb 2016.||NCT02207621|