TGA Archives - Insight

Eye disease AI screening system TGA-approved

Staff Writer — Mon, 25 Apr 2022 23:34:07 +0000

A spotlight will be shone on issues like artificial intelligence, gene therapy and bioengineered corneas.

The Therapeutic Goods Administration (TGA) has approved a new AI software system that can screen for three major eye diseases in primary care settings. The iPredict System was cleared for Australian use
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Low-dose atropine EIKANCE secures first myopia TGA approval

Staff Writer — Thu, 17 Mar 2022 23:40:17 +0000

Eikance 0.01% atropine was approved by the TGA in September 2021.

The Therapeutic Goods Administration (TGA) has approved EIKANCE 0.01%, Australia’s first low-dose atropine eye drop for myopia progression in children and young teenagers. The eye drop therapy – with
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Prednefrin Forte supply to be reinstated in February 2022

Myles Hume — Fri, 28 Jan 2022 02:30:41 +0000

The evidence is sound that HA is a lubricant with desired properties and performance, Martin Robinson says.

Allergan has confirmed Prednefrin Forte (prednisolone acetate and phenylephrine hydrochloride) eye drops (10mL) will be available once again across Australian pharmacies in February 2022. Due to manufacturing
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Tasmanian centre joins race for CRISPR blindness cures

Myles Hume — Fri, 12 Nov 2021 04:54:33 +0000

A derelict water tank has been refitted to house the proposed Ophthalmic Gene Therapy Centre in Hobart.

In 2016, at his home RANZCO scientific branch meeting in Tasmania, preeminent ophthalmic genetics expert Professor Alex Hewitt presented on the transformative impact of CRISPR/Cas9 gene editing
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Glaukos announces TGA approval of late-stage glaucoma implant

Myles Hume — Wed, 09 Jun 2021 22:36:40 +0000

Glaukos has exclusive commercialisation and development rights for the MicroShunt in Australia.

Glaukos has secured Australian regulatory approval for the Preserflo MicroShunt, offering late-stage glaucoma patients a more elegant surgical alternative to conventional filtration procedures. The ophthalmic
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Prednefrin Forte shortage – TGA approves alternative product

Myles Hume — Tue, 01 Jun 2021 22:31:40 +0000

The company was alleged to manufacture eye drugs in multi-use bottles, without an adequate preservative.

Allergan has secured regulatory approval for an alternative product to address a Prednefrin Forte shortage in Australia. The company confirmed to Insight it had received a Read More

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Prednefrin Forte shortage: supplier working towards providing alternative

Myles Hume — Tue, 27 Apr 2021 22:58:27 +0000

Four cases of enucleation and four deaths are alleged to have occurred from the contaminated drops.

The Therapeutic Goods Administration (TGA) has confirmed a shortage of Prednefrin Forte 10mL eye drops in Australia, which isn’t expected to be available until January next year, but its supplier
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Clinical trial results reinforce potential new treatment for DME

rhiannon bowman — Thu, 17 Dec 2020 01:11:54 +0000

Novartis is working with regulatory authorities to bring Beovu to DME patients.

Novartis has announced positive findings from its the Phase 3 trial assessing the efficacy and safety of Beovu (brolucizumab) to treat diabetic macular edema (DME). KESTREL is the second pivotal Phase
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TGA approves Luxturna gene therapy

Myles Hume — Tue, 25 Aug 2020 23:29:58 +0000

Novartis secured Australian regulatory approval for the gene therapy on 5 August.

In a historical development for the eye health sector, the Therapeutics Goods Administration (TGA) has approved the country’s first true gene therapy, indicated for a rare form of inherited retinal disease
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TGA approves ‘breakthrough’ B+L contact lens

Myles Hume — Mon, 24 Aug 2020 03:39:15 +0000

The TGA took just two weeks to approve the contact lens.

Bausch + Lomb has obtained regulatory approval to supply its new Ultra One Day daily disposable silicone hydrogel (SiHy daily) contact lenses in Australia. The new lens design was recently cleared by the
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