Allergan

FDA approves first eye drop to treat presbyopia

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Allergan, an AbbVie company, announced the FDA approval of the eye drop, Vuity, for the treatment of presbyopia.

The approval for the pilocarpine HCl ophthalmic solution 1.25% was granted Oct. 28, according to the FDA’s website.

“”We are proud to offer Vuity as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia,” Michael Severino, MD, Abbvie vice chairman and president, said in a press release from the company.

This daily prescription eye drop takes effect in as little as 15 minutes and can last up to 6 hours, the company said in the release, improving near and intermediate vision without affecting distance vision.

The pilocarpine is delivered with pHast technology, which allows the solution to rapidly adjust to the tear film’s pH, according to the release.

The company said the FDA approval is based on data from two phase 3 clinical studies, GEMINI 1 and GEMINI 2. Both studies saw statistical significance in improvement of at least three lines in near vision in low light conditions without losing more than one line of distance vision on day 30 at hour 3.

No serious adverse events were seen in either study. The most common were headache and ocular redness in more than 5% of subjects.

PERSPECTIVE

John A. Hovanesian, MD, FACS)

John A. Hovanesian, MD, FACS

Approval of Allergan’s Vuity eye drop for treating presbyopia ushers in a new era of pharmaceutical treatments for refractive error. With several other presbyopia drops in trials, clinicians will soon have choices for helping patients avoid reading glasses. Furthermore, several drops are also seeking approval for halting progressive myopia in young patients. No longer are corrective lenses and surgery the only choices for improving eyesight.

‘Needle risk’ over beauty treatments.

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A health watchdog is concerned that people having beauty treatments like Botox could be at risk of infection from dirty needles.

The National Institute for Health and Care Excellence says growing numbers of people are injecting tanning agents, dermal fillers and Botox at home and in salons, and some are lax about hygiene.

Sharing needles can spread blood-borne diseases like HIV and hepatitis C.

Nice is updating its advice for England and Wales accordingly.

The guidelines, which are out for public consultation, aim to encourage people to use sterile needle and syringe programmes to stem the spread of infections.

Sharps bins

Most blood-borne diseases occur among people who inject drugs like heroin and anabolic steroids.

But NICE says people seeking out cosmetic fixes are also at risk.

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The dangers of sharing needles in cosmetic injectables are so great that any practitioner who does this should be considered guilty of a criminal offence and nothing less”

President of BAAPS Rajiv Grover

A spokeswoman said: “We are seeing an increasing issue with drugs that are used for vanity purposes.”

This includes the anti-wrinkle treatment Botox, dermal fillers and tanning agents.

Prof Mike Kelly, Director of the NICE Centre for Public Health Excellence, said: “Since we last published our guidance on needle and syringe programmes in 2009, we’ve seen an increase in the use of performance-and-image-enhancing drugs such as anabolic steroids, Botox, tanning agents and the use of dermal fillers like collagen.

“We’ve also heard anecdotal evidence that more teenagers are injecting these performance-and-image-enhancing drugs too.

“We’re updating our guidance – and our public consultation on the draft update is an important part of this process – to make sure all of these groups of people are considered in the planning and delivery of needle and syringe programmes.”

One of the recommendations proposed in the new guidelines is that local councils consider providing sharps boxes for people to dispose of used needles and syringes.

Rajiv Grover, consultant plastic surgeon and president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said: “Due to the lack of regulation in the cosmetic sector it is impossible to know how many patients could be at risk of blood borne diseases from needle sharing with either Botox or fillers.

“These should be considered medical procedures and BAAPS has campaigned for over a decade to have this field of non-surgical cosmetic treatments tightly regulated. The dangers of sharing needles in cosmetic injectables are so great that any practitioner who does this should be considered guilty of a criminal offence and nothing less.”

Allergan, a healthcare company that provides Botox, said that Botox is a prescription-only medicine which should only be administered by a trained and qualified medical healthcare professional.

“These treatments should be carried out by appropriately trained and qualified medical practitioners, who have high levels of expertise in full-face anatomy and can provide sufficient aftercare and redress for the patient in the event of an adverse event,” said a spokesman.