OTE Staff Reports

home

authors

ote-staff-reports

Bausch + Lomb and Clearside Biomedical Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application for triamcinolone acetonide suprachoroidal injectable suspension (Xipere).

The agency determined that the filing is a Class 2 resubmission and assigned a Prescription Drug User Fee Act (PDUFA) action date of October 30, 2021, for the investigational therapy with a proposed indication of treatment of macular oedema associated with uveitis.

“If approved by the FDA, [triamcinolone acetonide suprachoroidal injectable suspension] would be the first therapy available utilising the suprachoroidal space for patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis,” said Yolande Barnard, vice president and general manager, US Pharmaceuticals, Bausch + Lomb, in a prepared statement.

“If approved, [this] would be our first commercial product and the first approved drug to be delivered into the suprachoroidal space (SCS),” added Clearside’s President and CEO George Lasezkay, PharmD, JD.

The novel treatment option is designed for suprachoroidal administration via Clearside’s proprietary SCS microinjector that provides access to the back of the eye, where sight-threatening disease often occurs.

An affiliate of Bausch Health acquired the exclusive license for the commercialisation and development of triamcinolone acetonide suprachoroidal injectable suspension in the United States and Canada in October 2019.

The Bausch Health affiliate also has exclusive options for the right to commercialise and develop the novel treatment option in the European Union, the United Kingdom, Australia and New Zealand, and/or South America and Mexico. Arctic Vision has the exclusive license for its commercialisation and development of in Greater China and South Korea. Triamcinolone acetonide suprachoroidal injectable suspension is not yet approved in any jurisdiction.

Articles

PDUFA action date of October 30, 2021, is assigned for investigational therapy with a proposed indication of treatment of macular edema associated with uveitis.

FDA accepts Bausch Health, Clearside Biomedical's resubmitted Xipere NDA 

In a strategic move by the company to align their name with their future, BELKIN Laser will now be known as 

. The Israel-based medical device company will continue to supply fast, accessible 

 laser treatment as well as reinforcing their focus on additional ophthalmic challenges.

BELKIN Vision made a splash in the glaucoma treatment industry with their fast, no-contact laser. While other glaucoma treatments—such as daily drops or invasive lasers—pose issues of poor patient adherence and significant time requirements, the 

 enhances intraocular fluid drainage in about a second via delivery of a single laser beam to the limbus.

"When we started the company in 2013, we always imagined that it would transport us to the stage we're at today. Now, on the cusp of commercialization, we anticipate a multitude of exciting future applications and wanted to ensure that our company name aligned with that vision. We're confident that BELKIN Vision perfectly reflects our future plans and will capture the hearts and minds of our future customers," said Daria Lemann Blumenthal, CEO of BELKIN Vision.

For more information, visit BELKIN Vision’s 

The glaucoma treatment company rebrands to align more closely with goals and direction of the company.

BELKIN Laser rebrands as BELKIN Vision

The Royal College of Surgeons of Edinburgh (RCSEd), a leading surgical college, announced the launch of its own Membership of the Royal College of Surgeons (MRCS) ophthalmology examination.

This new examination will be available in early 2022, and a Fellowship examination will follow later in the year.

“We would like to thank the ICO for the very positive relationship we have enjoyed over the last few years and wish them the best in their pursuit of improving standards in global Ophthalmology care,” said Professor Michael Griffin OBE, President of the RCSEd. “We are delighted to now have the opportunity to launch our very own MRCS Ophthalmology and look forward to adding a Fellowship examination next year, ensuring those in the profession will have a continued route into College membership.”

RCSEd was first incorporated as the Barber Surgeons of Edinburgh in 1505, and it has since grown to nearly 29,000 members from 100 countries worldwide, with 15,000 in the UK. As one of the oldest surgical corporations in the world, the College promotes the high standards in surgical and dental practice. The College is also home of the UK’s only Faculty of Surgical Trainers, which is open to anyone with interest in surgical training, regardless of College affiliation.

All ICO College Members—including the April intake of this year—are eligible for the full benefits and services the College offers.

A new MRCS ophthalmology examination will be offered to ICO College Members beginning in 2022.

Royal College of Surgeons of Edinburgh launches MRCS ophthalmology exam, Fellowship to follow

Johnson + Johnson Vision announced today it is kicking off the availability of its TECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the treatment of 

 allows for high-quality vision at both intermediate and far distances

 and is specifically engineered for rotational stability.

 The lens allows patients to achieve significantly improved intermediate vision, compared with a standard aspheric monofocal IOL, along with 20/20 distance vision.

According to Filomena Ribeiro, MD, PhD, FEBO, head director of ophthalmology at Hospital da Luz in Lisbon, Portugal, the haptic design and rotational stability of the TECNIS Eyhance Toric II IOL, has allowed her to offer her patients immediate improvements in their functional vision, while also correcting their astigmatism.

“Having implanted the TECNIS EyhanceToric II IOL, I can confidently say that this IOL is a game-changer in the monofocal category and in helping my patients get back to spending more time doing what they love,” she said in a statement.

Posterior corneal elevation: Is there a role for premium IOLs?

A survey of 17 leading European ophthalmologists found that their patients were satisfied with the lens.

 Meanwhile, more than 79% perceived their patients as being very satisfied with their intermediate and distance vision.

Additionally, 94% of those surveyed were very satisfied with the handling while implanting the lens, while nearly two thirds rated the overall performance of the lens as excellent compared to other toric IOLs.

 More than 80% also rated the rotational stability of the lens as excellent compared to other toric IOLs. All those surveyed said they were very likely to continue to use the lens in the future.

Ray tracing and IOL modelling in AMD patients

Erin McEachren, regional vice president, EMEA, Johnson + Johnson Surgical Vision, said the rollout offers the benefits of its most advanced monofocal IOL to cataract patients with astigmatism.

“It is an important first in Europe for the monofocal IOL category, as today most lenses in this category only correct vision to help patients with cataracts see things at a distance, and therefore do not improve the intermediate vision that is required for many important daily tasks,” McEachren said in a statement. “This is another breakthrough in meeting the ever-changing and evolving needs of our patients across Europe and the world.”

DOF2018CT4015 – Clinical evaluation of the TECNIS Eyhance Model ICB00 – 6-month clinical study. Sep 2018. Based on a clinical study, N=134 achieved mean 20/20 monocular pooled distance BCDVA.

TECNIS Eyhance Toric II IOL – Survey of 17 surgeons about experiences with DIU. May 2021. REF2021CT4156.

According to the company, more than 400 eyes of patients from 12 European countries have been fitted with the TECNIS Eyhance Toric II IOL, with surgeons surveyed noting that their patients are pleased with the results. 

Author | OTE Staff Reports

Articles

BELKIN Laser rebrands as BELKIN Vision

Royal College of Surgeons of Edinburgh launches MRCS ophthalmology exam, Fellowship to follow

Johnson + Johnson's TECNIS Eyhance Toric II IOL launches in Europe

FDA accepts Bausch Health, Clearside Biomedical's resubmitted Xipere NDA