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Honouring the preservative-free mantra

Ophthalmic products are a significant contributor to AFT Pharmaceuticals’ bottom line. Combined with an unmet need for preservative-free products, the company is highly motivated to expand its pipeline, says CEO and founder DR HARTLEY ATKINSON.

Since its inception in 1997, New Zealand-born company AFT Pharmaceuticals has established itself as one of the major players in the Australasian pharmaceutical market, often perceived as punching above its weight against the offshore multinationals.

An example is its eyecare portfolio of preservative-free eye drops, which has elevated the company into the number two spot in the eye lubricants segment – with 25% market share – and pharmacy data showing its HYLO-Forte eye drop is the best-selling product by value.

AFT was famously started by Dr Hartley Atkinson and his wife Marree out of their family garage in Auckland 24 years ago. While it now counts itself among the multinationals with 98 employees and subsidiaries in Auckland, Sydney, Kuala Lumpur, Singapore and Ireland, Atkinson says it remains nimble enough to swiftly respond to consumer trends and overseas innovations.

The company’s eyecare portfolio is no exception, with a full pipeline containing new therapies for glaucoma and bacterial eye infections, as well as a ciclosporin for dry eye. Importantly, they fit with the company’s preservative-free approach, which is its differentiator in response to evidence that preservatives – often benzalkonium chloride – can aggravate the eye.

The ASX and NZX-listed company’s current ophthalmic portfolio is distributed to Australian optometrists and ophthalmologists by Melbourne-based supplier Good Optical Services. It has now grown to seven products out of 65 proprietary and licensed drugs in Australia, accounting for around 25% of the company’s overall revenue.

“Most companies have found the past 12 months challenging given the current ongoing pandemic, but we were pleased last year to grow sales again by finishing the 2021 financial year with $113 million in revenue, up from $105 million,” Atkinson says.

“I think if it hadn’t been for the pandemic, we would have had greater growth. We see good potential to keep growing, especially our Australian market, to well over $100 million (currently $68 million), and the eyecare products continuing to be a quarter of that. Some companies arguably have a broader [ophthalmic] range, but we have decided to focus our portfolio and make preservative-free our mantra.”

An expanding portfolio

Until now, AFT’s ophthalmic portfolio has largely focused on products for a complete dry eye care regime, with heat packs, wipes and lubricants. However, the range is set to take on another dimension in 2022.

The first of these will be a product called Ocuzo, which is a chloramphenicol 5mg/mL pharmacist-only preservative-free 10mL eye drop that will launch in the first quarter. It’s an antibiotic for bacterial eye infections. Bacterial conjunctivitis is an infection involving the mucous membrane of the surface of the eye. There is a comparative product already available, but it’s not preservative-free, indicating a significant unmet need for patients, Atkinson says.

“We have registered Ocuzo and are preparing for the launch at the moment, so watch this space,” he says.

AFT’s Australian revenue rose 11% to $68 million in FY21, with ophthalmic products accounting for around a quarter.

“It’s a significant market with around 600,000 packs of chloramphenicol sold in Australia annually for minor ocular bacterial infections. The thinking behind this was if you have an already irritated eye from a bacterial infection, it would be an advantage to have a preservative-free version where you are not looking to cause any additional irritation from a preservative.”

The other major launch slated for next year features two prescription glaucoma therapies under the umbrella brand Vizo PF. The first to launch will be dual agent dorzolamide + timolol variant, which will become the market’s only preservative-free version. The company is current evaluating the launch date for a bimatoprost 300 micrograms/mL solo agent eye drop for which there are already other preservative-free options, however these aren’t available in a multidose bottle.

“Once again, it’s the same logic, a disease like glaucoma is a long-term condition that doesn’t go away. Eyecare professionals have told us they would like the option of a preservative-free product because some patients do have some irritation from preservatives in current treatments,” Atkinson explains.

Since last speaking with Insight a year ago, AFT has introduced NovaTears + Omega-3, a line extension of the popular NovaTears eye drop for evaporative dry eye and meibomian gland dysfunction, that itself arrived in 2018 from the German firm Novaliq.

Launched in November 2020, NovaTears+ Omega-3 combines perfluorohexyloctane and concentrated Omega-3 fatty acids of algae origin. It has been developed based on research suggesting deficiencies of Omega-3 tear film lipids may be a driver for chronic ocular surface inflammation in dry eye disease. Essential fatty acids (EFAs) – like Omega-3 – are required for healthy metabolic processes, but humans cannot produce these and must acquire them through supplementation or dietary sources.

“The majority of patients do have a degree of evaporative dry eye and the NovaTears products specially address that,” Atkinson says, noting the NovaTears products have been a major factor in propelling AFT into the number two position in the lubrication eyecare category.

“NovaTears + Omega-3 is looking at the patient with evaporative dry eye, but also degree of irritation, as well as redness of the eye and eye lid – and this is a reasonable-sized sub-category of dry eye.”

NovaTears + Omega-3 launched last year.

An added benefit of AFT’s products is its multi-dose containers, which the company says deliver accurate drop sizes to the eye, minimising drop wastage sometimes seen in unit dose products. Multi-dose containers – as opposed to single-use ampoules – also result in less plastic waste.

Atkinson says the company is launching a new packaging initiative in its dry eye products, but in a different way.

AFT’s dry eye portfolio is built around a “heat, clean and hydrate” message that emerged from the DEWS II work. This is reflected in its Opti-Soothe heat mask, Opti-Soothe eye lid wipes and eye drops comprising the two NovaTears products, HYLO-Forte and HYLO-Fresh.

Atkinson says eyecare professionals are increasingly promoting the importance of a holistic dry eye regime to patients. This has similarities to the dental profession that drastically improved oral hygiene over recent decades by promoting a preventative approach around brushing, flossing, fluoride and regular check-ups. To underpin this approach, AFT will be packaging a combination of its products so patients can purchase a complete dry eye regime in the one box. With most patients having the evaporative form of the disease, the company is beginning with NovaTears, combined with the Opti- Soothe heat mask, and Opti-Soothe wipes.

“We think this is an important add-on, having the eyecare pack containing a three-step plan, which is also easier than going to your optometrist and pharmacist and having to navigate your way around two to three items,” Atkinson says, noting there will be a cost saving for purchasing the bundled pack.

“By not being a huge company compared to some of our competitors, it means we can remain quite nimble – we find things that our customers tell us will be helpful and respond.”

A new ciclosporin

While AFT has reported success with the NovaTears range to date, its relationship with the manufacturer Novaliq may go deeper yet, with the company putting significant resources behind a ciclosporin eye drop, currently in the clinical development phase.

The therapy is called CyclASol, which is a topical anti-inflammatory and immunomodulating ophthalmic drug solution, containing 0.1% cyclosporine A for dry eye. The formulation contains the company’s EyeSol technology that also underpins the NovaTears products.

As a result, Novaliq says the drug increases residual time on the ocular surface and enables a high bio-availability in the target tissues to exploit the potential of cyclosporine A. It has also touted fast onset of action within two weeks.

“Certainly, the NovaTears base is particularly good at dissolving lipid soluble molecules that are not easily dissolved in an aqueous media,” Atkinson says.

“Combining this with a ciclosporin is an interesting prospect. There is already impressive clinical data available and it looks robust in terms of the end points. This is something we are also working on for the Australian market and could be really exciting long term.”

The CyclASol program is in late-stage development with three completed clinical trials, Novaliq reported.

Other initiatives

Elsewhere, AFT has used its eyecare business to contribute to charitable causes in Australia and across the world. Closest to home were the 2020/21 bushfires in Western Australia where firefighters from Murdoch Fire Station in Perth were donated HYLO-Fresh and HYLO-Forte eye drops and NovaTears to relieve irritation from the heat and smoke.

Each year the company also seeks to reduce health inequalities in developing nations. Typical beneficiaries are the AusViet Charity Foundation and Eyes4Everest.

With AusViet, in Phu Tho, Vietnam, in August 2019 AFT provided 500 boxes of HYLO-Fresh and 200 boxes of Cromo-Fresh allergy drops.

For Eyes4Everest, a charity delivering eyecare to Himalayan communities founded in 2013 by Sydney optometrist Mr Shaun Chang, AFT has previously donated 50 boxes of HYLO-Forte drops for a population that suffers from a high prevalence of dry eye syndrome.

Although efforts have been hampered due to the pandemic, Atkinson says it’s important the company continues to have a social impact.

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