Glaucoma marks the next horizon for AFT Pharmaceuticals, as it seeks to solidify its position as a leader in the ophthalmic eye drop market with preservative-free-only products, CEO HARTLEY ATKINSON says.
The Australian ophthalmic market continues to be a happy hunting ground for New Zealand-based AFT Pharmaceuticals, with the company poised to build on its rapid success in the dry eye space with an expansion in prescription glaucoma therapies later in 2022.
The NZX and ASX-listed firm has continued its annual trend of posting a record operating revenue, with its latest FY22 figures reaching $130 million, up 15% on the previous year. Australia continues to be its largest market, accounting for around 60% of sales, growing by 12.3% to $76.7 million.
Founder and CEO Dr Hartley Atkinson says the company’s eyecare portfolio has gone from strength-to-strength in Australia, with AFT enjoying a niche in offering licensed preservative-free ophthalmics. Well-established dry eye products, including the HYLO range, NovaTears, and Opti-Soothe heat and eyelid wipes – supplied by Good Optical Services – have continued their growth trajectory and, as such, AFT has retained the number two position in the lubricating eyecare category in Australia and the number one selling product (HYLO-Forte).
AFT’s overall Australia FY22 revenue growth has largely been driven by new launches, with the most notable eyecare products being its preservative-free treatment for eye infections, Ocuzo, and a new Opti-Soothe 3-in-1 eyecare treatment kit for dry eye.
Atkinson says the company has also been “pleasantly surprised” with the performance of NovaTears + Omega-3, a line extension of the popular NovaTears eye drop introduced only two years ago that combines perfluorohexyloctane and concentrated Omega-3 fatty acids of algae origin.
“That product has done better than we expected and quite a few of our customers have seen the benefit and point-of-difference created by having Omega-3 included in the formulation, as opposed to a strategy of taking fish oil supplements,” he says.
“One of the advantages of the NovaTears base (EyeSol) is that you can dissolve compounds that are not water soluble, where most eye drops are relying on something like an emulsion, which can cause blurring. So it’s a unique formulation in that respect.”
Ocuzo, AFT’s chloramphenicol 5mg/mL pharmacist-only 10mL eye drop launched in the first quarter of 2022, is also making in-roads as the only preservative-free option in its category, with an addressable market of 600,000 units per year.
“That’s a significant market; chloramphenicol eyedrops traditionally contain preservatives so we saw an opportunity with preservative-free, because when you’ve got an eye infection, you wouldn’t want to be putting anything else extra that might cause irritation,” Atkinson adds.
“Overall, we are seeing good growth in our eyecare portfolio. We’re in seven therapeutic areas in Australia, and ophthalmology is our largest chunk of revenue. We want to keep growing it, which is why we are expanding in glaucoma therapies.”
Glaucoma therapy to be PBS-listed
While much of the focus has been on AFT’s dry eye and chloramphenicol range, the company is set to make its well-documented foray into glaucoma later this year.
The company currently has three approved preservative-free versions of well-established glaucoma therapies licenced from Europe, which it will market under the umbrella brand Vizo PF.
The first to launch this December will be Vizo-PF Dorzolatim dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop solution multi-dose. Its main comparator is currently Cosopt.
The company is currently evaluating the launch date for a Vizo-PF Bimatoprost 300 microgram/mL (comparator Lumigan PF), which has been recommended for PBS listing. AFT also has approval for Vizo-PF Bimatotim 0.3/5 bimatoprost 300 microgram/mL and timolol (as maleate) 5 mg/mL.
With respect to Vizo-PF Dorzolatim, the Therapeutic Goods Administration has approved this for elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.
“This is a classic glaucoma product that’s been approved in the Australian market. We’ve applied for a PBS listing, and we’re looking to launch that on 1 December. The opportunity we saw is that although there are some glaucoma products that are preservative-free, they’re generally in single dose ampoules, which are fiddly to use and cause environmental waste, so we saw this as a better option,” Atkinson says.
“Like dry eye, glaucoma is a long-term condition that unfortunately doesn’t suddenly resolve overnight. So having a preservative-free product that avoids irritation and that is easy to use in a multidose container seems to be a useful angle for patients and the Australian market.”
The Pharmaceutical Benefits Advisory Committee (PBAC) recommended Vizo-PF Dorzolatim for PBS-listing at its March 2022 meeting. In its submission, AFT estimated it would substitute for 5% market share in the first year of listing (5,000 to < 10,000 prescriptions), increasing to approximately 25% by year six (30,000 to < 40,000 prescriptions).
On the horizon
Hartley says AFT’s Australian operations – which has increased to 40 people – are expanding, as the company sets a goal to crack $100 million in revenue in the country.
He anticipates that will happen in 2023/24, largely thanks to the fact AFT did not let the pandemic slow the growth of expanding its licensed portfolio, which currently account for 75-80% of its entire range.
“We continue to see considerable opportunities to accelerate growth and have significantly increased both our in-licensing and product R&D pipeline activities where we are also now looking into eyecare. We also believe the gradual move worldwide to living with COVID and our ability to now travel across borders to meet with both existing and new customers will allow a gradual return to a more normal trading environment,” Atkinson says.
“Our pure drug development business develops products for global markets. We’re selling into about 58 countries around the world at the moment, and we are trying to build that over the next couple of years to around 100.”
While he can’t comment at length, Atkinson is also watching with interest as German ophthalmic product manufacturer Novaliq applies to the US Food and Drug Administration for a new cyclosporin ophthalmic solution for dry eye disease. Novaliq is the producer of the NovaTears range, supplied by AFT in Australia and New Zealand, and the cyclosporine product, called CyclASol, uses the same pioneering water-free technology EyeSol.
CyclASol has reportedly demonstrated in two independent adequate and well-controlled, multicentre studies (ESSENCE-1 and ESSENCE-2) clinically meaningful and statistically significant improvements in the indication.
Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining (tCFS) score favouring CyclASol in both studies at days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement of ≥3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies.
Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints.
Head-to-head data versus Restasis (cyclosporin) from a phase 2 study suggest that CyclASol has a stronger and faster therapeutic effect on the ocular surface, Novaliq reported.
“This is the first submission of a novel product category of water-free topical drug therapies utilising EyeSol as a drug carrier,” Novaliq CEO Mr Christian Roesky says.
“CyclASol is a first-of-a-kind drug therapy and aims to expand treatment success for patients with dry eye disease and their eyecare professionals. If approved by the FDA, CyclASol addresses important unmet medical needs in dry eye disease through its ocular surface healing effect combined with high comfort of administration.”
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