Fixed dose combination levofloxacin and dexamethasone eye drops approved by South Africa regulators

24 Nov 2021 --- The South Africa Health Products Regulatory Authority (SAHPRA) has issued a positive outcome for the fixed dose combination of levofloxacin and dexamethasone multidose eye drops.

The license and rights of the patented formula was granted to Italy-based NTC and Aspen Pharmacare Holdings, a South African specialty and branded pharmaceutical company. This covers the commercialization of the formula in South Africa and other African countries.

It is the first approved fixed combination of an ophthalmic quinolone antibiotic (levofloxacin) with an anti-inflammatory steroid (dexamethasone) eye drops solution indicated for the prevention and treatment of inflammation and the prevention of infection associated with cataract surgery in adults.

A new vision
NTC provides full technical and regulatory support to Aspen in the sale of its formula.

Riccardo Carbucicchio, president and CEO of NTC, says his company is excited to have achieved regulatory approval in half the time compared to standard timeframes.

NTC and Aspen have announced a positive outcome for the fixed dose combination of levofloxacin and dexamethasone multidose eye drops.“We trust that many patients undergoing cataract surgery will benefit from our innovation in South Africa.”

“Aspen is pleased to enter into a South African partnership with NTC to commercialize this novel combination for the prevention and treatment of eye inflammation and the prevention of infection associated with cataract surgery in adults,” adds Richelle Crots, Aspen Pharmacare Regional CEO, SA Commercial.

“This partnership will bolster Aspen’s vision of providing high quality, affordable products to patients. We are excited to have been offered the opportunity to launch this innovative product in the local ophthalmology market segment,” Crots notes.

This novel NTC fixed combination product has now been partnered and out-licensed by NTC across nearly 80 countries globally.

Eye health spotlighted
In light of the COVID-19 pandemic increasing consumers’ screen time, industry is rolling out innovations to address eye health.

In August, well-being supplements specialist Neurohacker Collective launched Qualia Vision, a “comprehensive nutritional defense” against digital eye strain, including Lutemax 2020 and MirtoSelect Bilberry.

Also in the space, PharmaLinea unveiled a line of preventative eye health supplements in consumer-friendly formats in May.

In September, OmniActive commercially launched Nutritears in the US, following its introduction in July. The combination of ingredients addresses occasional dry eyes and is formulated with lutein and zeaxanthin isomers, curcuminoids and vitamin D3.

Last month, US-based Unibar partnered with Josh Naturals in Germany to offer capZion in Europe, the first eye health capsanthin product to be made available in the continent in oral form.

Edited by Elizabeth Green

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