FDA Clearance of Lensar’s ALLY Adaptive Cataract Treatment System
In the last week, LENSAR, Inc. have announced their #FDA clearance for ALLY Adaptive Cataract Treatment System. This is the first FDA-cleared platform to enable cataract surgeons to complete femtosecond-laser assisted cataract surgery procedure in a single environment. ALLY is the first cataract surgery platform to provide ‘Adaptive Intelligence’ to determine cataract density, optimise fragmentation patterns as well as energy settings.
"ALLY is really going to be unique in many, many ways. The system is a fraction of the size of current femtosecond lasers. In fact, it’s just slightly larger than phacoemulsification systems are today in most of the facilities." Nick Curtis, CEO of Lensar. Phacoemulsification is the most commonly performed cataract technique, it is hoped femtosecond-laser assisted cataract surgery will overtake this.
The FDA clearance is for system’s femtosecond laser capabilities. It is in the first stage of its commercial release, first to a controlled targeted audience of surgeons in the third quarter of 2022. In 2023, Lensar intend to make ALLY widely available to cataract surgeons.
Myopia Drug Licencing Agreement Entered
Vyluma and Laboratoires Théa have entered a licencing agreement for the registration and commercialisation of childhood myopia drug NVK002 in Canada, Mexico and some South American countries, expanding the previous agreement for Europe and other select countries.
NVK002 is an investigational, preservative-free eye drop to use nightly and intended for slowing the progression of myopia in children ages 3 to 17. It is currently under late-stage clinical evaluation in the Childhood Atropine for Myopia Progression study being carried out in the US and Europe.
“Théa has been an acknowledged pioneer in preservative-free eye care treatments, and by expanding the scope of the agreement signed in 2021, more patients will now have access to this important new therapeutic.” Raul Trillo, MD, MBA and CCO Vyluma.
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Aldeyra Therapeutics Achieve Phase 3 Primary Endpoint for Dry Eye Disease Treatment
Aldeyra Therapeutics have announced the achievement of the primary endpoint in their Phase 3 TRANQUILITY-2 clinical trial of their investigational new drug Reproxalap. The drug was a superior vehicle for two prescribed end points – Schirmer test (the most common test for drug approval for fry eye disease) and ≥10 mm Schirmer test responder proportions after 1 day of dosing.
“I am extremely encouraged about the Schirmer test results and the other clinical sign endpoint data produced by reproxalap, highlighting the broad therapeutic benefit this therapy may bring to patients suffering from dry eye disease.” Cathleen McCabe, MD and Chief Medical Officer at Eye Health America.
A Type B Pre-NDA meeting is expected to be held with the FDA in the third quarter of 2022, followed by a potential NDA submission.
Rayner Acquires Stake in Surgical Instrument Company
Rayner have announced their acquisition of a stake in Belgian Manufacturer HASA Optix Belgium, a sustainable surgical instrument company.
"Partnering with Hasa Optix means that we can assist ophthalmologists with an additional part of the surgical procedure and further supports our mission of being focussed on providing the best visual outcomes for clinicians and patients.” Tim Clover, CEO Rayner.
Hasa Optix surgical instruments will be available from Rayner in selected countries later this year.
Imagine waking up, reaching out for your book, opening it at your bookmark and realising you can’t make out the words on the page. This is the reality for people with presbyopia. Presbyopia is the gradual loss of the eyes ability to focus on nearby objects due to the loss of elasticity of the eye’s natural lens.
Presbyopia affects over 120 million people in the US alone, and 2.1 billion people globally. Currently it can only be treated through the wearing of contact lenses of reading glasses. Fortunately, a new treatment is on its way to the market – Eyedrops. As a treatment, eyedrops are believed to offer more freedom to patients. We spoke to Marjan Farid, Director of Cornea, Cataract, and Refractive Surgery at the Gavin Herbert Eye Institute, UC-Irvine who believes these products could quickly become a core solution offered by optometrists as they easily be prescribed.
Eyedrops as an alternative treatment to contact lenses and reading glasses is an increasingly promising development. Allergan were first to post with their treatment Vuity. They received FDA approval of their eyedrops in October 2021, however being first to the market does not necessarily mean it is the most effective product. We at Vision Executives have kept a close eye on the development of presbyopia eyedrops from several other companies: Lenz Therapeutics, Eyenovia, Ocuphire Pharma and Orasis Pharmaceuticals. Their exciting developments can be found in our newest article – The Presbyopia Revolution If you wish to read the full article please click here
In the last 30 years, concerted effort has been made to improve eyecare systems globally, yet there remain significant challenges which World Health Organization believe need to be urgently addressed.
Approximately 2.2 billion people globally have a visual impairment, half of which is treatable or preventable. According to Sightsavers, the number of people who are blind could triple by 2050 if we don’t urgently act and fund eye care effectively.
The latest world report on vision seeks to stimulate action in countries to address the significant challenges to eyecare by proposing integrated people-centred eye care (IPEC) as an approach to health system strengthening. It will build the foundation for service delivery to address the needs of a country.
“Eye health is an often-forgotten element of health and wellbeing, and this has led to a mounting global crisis. The ‘Eye care in health systems: Guide for action’ is a vital step to addressing this" Sumrana Yasmin, Senior Global Technical Lead: Eye Health URE at SightSavers.
Some of the recommendations by WHO are to:
✅Make eye care an integral part of universal health coverage
✅Implement integrated people-centred eye care in health systems
✅Promote high-quality research
✅Monitor trends and evaluate progress
✅Raise awareness and engage and empower people and communities
It is hoped that with these recommendations, urgent resource, funding, and efforts, we can fight our way out of the growing eye health crisis.
Link to the full report: https://www.who.int/publications/i/item/9789241516570
🎉 Vision Executives will be closed for the 2nd & 3rd June to celebrate 70 years of Her Majesty’s service to the people of Great Britain 👑
We believe the queen has displayed many outstanding #leadership qualities throughout her reign. Here are some of the most notable:
1️⃣ She served in World War II having signed up to the Auxiliary Territorial Services at the age of 18 and worked as a mechanic and truck driver. Her service makes her the only current living head of state to have served in World War II, and the only female member of the royal family to have entered the military.
2️⃣ Queen Elizabeth has done more for charity than any other monarch in the history of the world. She has truly made an impact that deserves respect in the field of charity and philanthropy having supported in raising over 1.4 billion pounds and helped millions of people all over the world.
3️⃣ Queen Elizabeth has been synonymous with integrity, resilience and stability having served the commonwealth for 7 decades of her life and continuing to do so despite being over 90 years old.
James Pickering is our Managing Director and an eye care recruitment expert who has developed an extensive client base and candidate network. He regularly writes articles about industry developments and has received numerous recommendations from industry leaders. You can also connect with James on LinkedIn to stay up to date on the latest eye care news.