Kala Pharmaceuticals might not be a name on everybody’s lips. But the private eye specialist is expecting three phase III readouts this year which, if successful, could trigger interest from bigger ophthalmology players such as Allergan or Shire.
The first pivotal data with Kala’s lead project, KPI-121, should come in the second quarter in patients who have undergone cataract surgery. But it is the more lucrative indication of dry eye disease, with two phase III trials due to report in the second half of the year, that could catapult Kala into the big time.
Even so, the group’s chief executive, Mark Iwicki, tells EP Vantage: “We are fully prepared to take it forward and launch it ourselves.” He points to his background launching various products during 20 years at Merck & Co and Novartis.
It is hard to imagine Kala turning down a serious offer, however, and Mr Iwicki concedes: “Things happen with companies like ours.”
Shire and Allergan already have dry eye products in the form of Xiidra and Restasis respectively. But Shire and Allergan’s drugs are used for chronic dry eye therapy, while Kala hopes to position KPI-121 – a nanoparticle formulation of the steroid loteprednol etabonate – as an option for earlier-stage patients.
Xiidra and Restasis are typically used “for the more severe or continual sufferers – someone who’s reached a point where they suffer every day”, according to the chief executive. Meanwhile, KPI-121 “can be used across the severity spectrum, but we envision it being used early in the development of the disease as people start to get three or four flares a year.”
In addition, KPI-121 could be given alongside Xiidra or Restasis as a treatment for flare-ups. “This is a little bit like the rescue inhaler for dry eye,” says Mr Iwicki.
He believes that there is room for both approaches and, rather than being concerned about competition, adds that the recent Xiidra launch “is doing well at expanding the market”. Around 54 million people in the US suffer from dry eye disease, and around 16 million are seeking treatment, analysts estimate.
Xiidra and Restasis are forecast to bring in $1.3bn and $849m respectively by 2022, according to EvalautePharma consensus forecasts. “Those products treat around 15-20% of the market,” Mr Iwicki says. “We can go after the entire market. Our preliminary estimates are that we should have a product that is capable of being a billion-dollar drug.”
To have a shot at this incredibly ambitious target, KPI-121 will first need to improve on mixed phase II data: a 150-patient trial hit on the primary sign endpoint of bulbar conjunctival hyperaemia, but missed on the primary symptom endpoint of ocular discomfort.
The two ongoing phase III dry eye studies are evaluating the same endpoints in 900 patients apiece, and Kala will hope for a more emphatic result.
The group plans to seek FDA approval via the relatively undemanding 505(b)(2) pathway. Loteprednol etabonate is already used for eye inflammation, but Kala’s nanoparticle formulation is designed to deliver around four times the amount of drug than traditional formulations, hopefully resulting in better efficacy.
After a $68m series C round last year the company has enough cash to get it through the NDA filings for both post-surgical inflammation and dry eye disease, Mr Iwicki says. “Right now we’re well funded through, let’s say, early to mid-2018.”
Further into the future, Kala has a preclinical tyrosine kinase inhibitor that “could be used for things like wet age-related macular degeneration or diabetic macular oedema... that hasn’t been decided yet”.
And Mr Iwicki believes the group’s mucus-penetrating particle technology might also have utility outside ophthalmology. “We designed these particles to flow through mucous membranes – that could be cervical or vaginal tract, or it could be lung.”
However, as a smaller player, Kala remains focused on the eye for now. “But we’re always talking and thinking about opportunities to license the technology for other diseases or tissue areas,” Mr Iwicki concludes.
|Indication||Trial ID||Data due|
|Post-surgical inflammation||NCT02793817||Q2 2017|
|Dry eye||NCT02813265||H2 2017|
|Dry eye||NCT02819284||H2 2017|