1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Allergan Crosses The Last Frontier in Ophthalmology

Ophthalmology companies have long recognized that many people will pay for the benefit of being able to see without wearing glasses. The success of LASIK laser surgery has borne this out, but that market is maturing. Presbyopia, the disorder that causes people to need reading glasses as they get older, isn't helped by laser surgery. It can, however, be helped by intraocular lenses. With Allergan's recent CE approval of an intraocular lens for presbyopia, ophthalmology companies see a new market to capitalize on.

Ophthalmology companies have long recognized that an enormous number of consumers will pay out-of-pocket for the benefit of being able to see without wearing glasses. The success of LASIK (laser-assisted in situ keratomileusis) has born this out. In the US, 2 million patients pay an average of $2,000 per eye to correct nearsightedness, and to some degree, farsightedness, in a procedure that uses lasers to flatten or steepen cornea. But the population of patients most willing and able to pay for options that give them freedom from spectacles, middle-aged presbyopics, currently has no refractive surgery option.

Presbyopia, the disorder that results in the need for reading glasses as people age, isn't helped by laser surgery, since...

Welcome to Medtech Insight

Create an account to read this article

Already a subscriber?

More from Regulation

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 
• By Amanda Maxwell

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 
• By Natasha Barrow

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

More from Policy & Regulation

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

From Imitation To Action: Johns Hopkins Robot Autonomously Performs Key Step In Gallbladder Surgery

 
• By Marion Webb

Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 
• By Malcolm Spicer

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.