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Opchat Magazine Industry NewsIndustry News, October to December 2020

Safilens blows out its first 20 birthday candles.
Tim Baker Joins Snowbird Finance
H2 Equity Partners (H2) has agreed to acquire pan European ophthalmology group Optegra from Eight Roads Ventures.
Retinal-imaging breakthrough to swiftly detect eye diseases
Cantor-Nissel now back at full power following the ups and downs of this year’s pandemic
Lumenis Launches Digital Duet SLT-YAG Platform
FMO Updates Members on big changes ahead for 2021
News of new Viral Treatment Trial for Covid-19 hospitalised patients
Repeat of Thealoz® Duo eye drops TV Campaign
Haag-Streit UK Announces Launch of the MR Q and MR Q Supine Laser Systems in the UK
The Ups and The Downs of the Covid-19 Hunt for a vaccination
1 October 2020 VAT changes for Opticians, more of a simplification than radical change
Read archived Industry News from July to September 2020

Safilens blows out its first 20 birthday candles.

December 2020

Twenty years of research, development and sales vitality have positioned the Italian company among the top players in the contact lens arena in Italy and ensure it an ever-increasing share of the international market.

Safilens celebrating 20 years
Established in early 2001, in partnership with the Safilo Group, in the spring of 2012 the company was acquired by Bruno Farmaceutici S.p.A., a merger designed to offer patients unique lens solutions that combined performance and comfort. Based on research, technology and the development of contact lenses, the merger leveraged innovation as the means of acquiring visibility in domestic and international markets.

A first 20 years made up of milestones. In 2005, Safilens patented the first contact lenses with hyaluronic acid release, the Safe-Gel line of contacts, and then solutions, which – thanks to the burgeoning interest elicited – paved the way to international markets, and to FDA approval in the United States.

In 2011, the highly advanced fusion technology™ was introduced that incorporates a co-polymer made of Tamarind-Seed Polysaccharides (TSP) and hyaluronic acid (HA) – the two natural polymers most used in the treatment of dry eye – into the contacts, thus ensuring optimal eye hydration and lubrication during their use.

The essence of this corporate blending of pharmaceuticals and contact lens technology was expressed in the Open 30 Project, the first Safilens silicone lens based on the patented fusion technology™.

These contact lenses offer one of the most advanced monthly contact lens management systems currently available in the marketplace. And, they were developed along with the company’s Open Reload solution and patented Sonic Wave Generator that ensures a thoroughly clean, disinfected and regenerated lens every day for the utmost in hygiene and wearer safety.

In 2015, Safilens developed and introduced the EDOF afocal lens design – initially in the daily fusion 1day presbyo version, and then in the weekly and monthly products – an easy, effective and immediate boon for presbyopes. The same concept was then employed in the less-stress-accommodation version for the use of video terminals and excessive proximal activity, making Safilens the first company in the world to introduce a fourth segment in the daily contact lens market.

“Research and development of Safilens products originates, as always, with close observation of lifestyles, continuous feedback from opticians, constant updating on materials, design and active ingredients, and with the desire to provide medical devices that improve the wearer’s experience and quality of life,” explained Safilens General Manager, Daniele Bazzocchi.

2020 was a noteworthy year, rife with challenges that – due to the global Coronavirus public health crisis – necessitated that Safilens management rise to the call to swiftly adapt its production and sales to support optical shops.

Enter the Len$Coin: a reloadable prepaid card that allows the purchase of a number of Safilens products at advantageous terms and conditions without quantity limitations on individual products, and can be used several times with transactions deducted from the total available.

In a year that had devastating effects on the world’s social, economic and healthcare systems, Safilens also engaged in solidarity activities for the common good. From March 22nd to April 15th, it promoted an initiative to benefit law enforcement, healthcare workers and emergency responders.

Participating optical shops distributed two-month’s-worth of daily contact lenses gratis to members of these groups engaged on the front lines in the battle against the COVID-19 pandemic. More than 300 partner shops across Italy provided over 10,000 packages of contact lenses for myopathy/hyperopia, astigmatism and presbyopia valued at nearly €280,000.

In early 2020, Safilens further expanded its internationalization efforts by partnering with the Dutch company, Oté. As the result of a mutually advantageous working relationship begun 10 years ago between their respective R&D departments for the development of innovative products, the partnership aims to combine the two companies’ manufacturing experience and sales structures through the formulation of new contact lens solutions and ensures the distribution of Oté products in Italy by Safilens and the inclusion of Oté’s solution portfolio in the product line of every company.

Thus, Safilens strengthens its position in international markets, where its products are distributed in 35 countries, thanks in part to the Safilens UK subsidiaries and Safilens Adria for the Balkans.

What does 2021 have in store for us?

The launch of a groundbreaking new product that goes well beyond the simply corrective function of the lens; it embodies the Safilens mission and its dynamic, independent and innovative DNA.

Tim Baker Joins Snowbird Finance

December 2020

Tim Baker newly appointed at Snowbird Finance
Tim Baker Joins Snowbird Finance from Shawbrook Bank to drive Treatment Finance into Optical Markets.

Snowbird Finance is delighted to announce that Tim Baker has joined the team as National Sales Manager to grow and increase Snowbird Finance’s patient finance offering under the brand of “Treatment Finance”.

Treatment Finance is a simple and affordable way for patients to spread the cost of their spectacle purchase and optical procedures or treatments including dry eye or Lasik, whilst ensuring your business experiences an uplift in revenue and profit. Flexible monthly payment options give patients the opportunity to proceed immediately with the treatment or purchase they want or need, without any delay.

Tim brings with him a wealth of knowledge and experience in retail and consumer finance spanning over 20 years. Tim will be driving the growth of the Treatment Finance programme for Snowbird across multiple medical verticals including optical dental, aesthetic, cosmetic, and veterinary, as well as strategically growing other markets out of the medical space.

In his previous role as National Sales Manager at Shawbrook Bank Tim was responsible, for developing the dental sector, as well as growing general retail finance in areas such as furniture, hi-fi and home improvements. Tim has also worked with many of the key players within the retail finance arena including Omni Capital, V12 Retail Finance and Black Horse Finance.

Tim Baker Commenting on the appointment “Joining Snowbird Finance was a natural decision for me when Shawbrook Bank withdrew from the medical finance sector, as I had always recognised Snowbird Finance’s commitment to dentistry. The company is also the fastest growing firm in the sector and has been building very rapidly on its well-known equipment finance and loan facilities available to the dental profession.”

Managing Director, Simon Freeman commented “We are delighted to welcome Tim to the company and utilising his extensive skills, knowledge and experience to drive demand. In addition, he has a deep insight into the FCA regulation and regulatory requirements available to dental practices. We are extremely confident that Tim will enhance the strategic vision of the business and will effectively deliver our finance solutions and products to practices and businesses across the UK.
To reach Tim directly, please call 07500 191912.

Snowbird Finance are long term supporters of your free Opchat News.

H2 Equity Partners (H2) has agreed to acquire pan European ophthalmology group Optegra from Eight Roads Ventures.

November 2020

Financial details of the transaction have not been disclosed but subject to regulatory approval, the deal is expected to complete early in 2021.

Eight Roads – a proprietary investment arm of investment house Fidelity – has backed Optegra since it was established in 2007 with a single site in Guildford, Surrey.

The company now operates 23 facilities across the UK, Czech Republic and Poland. Seven of these are in the UK, including its £12m flagship hospital in central London.

As well as the provision of critical eye care services, including cataract surgery and AMD, to the NHS, Optegra offers a wide range of vision correction services and holds ‘top three’ market positions in each of the geographies where it operates.

H2 said it would work closely with the existing management team led by CEO Dr Peter Byloos, who joined the firm in 2017, to deliver an ‘ambitious growth strategy’.

The deal represents the ninth investment for H2 Equity Partners Fund V, which was launched in February 2017 to invest in the UK, Ireland and the Benelux.

(Report by LaingBuisson)

Retinal-imaging breakthrough to swiftly detect eye diseases

November 2020

• New scanner in development to acquire light signal data at least 100 times quicker than OCT
• Eye diseases that lead to blindness require good quality images at an early stage
• Because the eye is constantly moving, OCT images suffer from blurring and often only partial pictures possible
• New patented 'switch' moves from 'bundle' to 'bundle' of 120 reference points in nanoseconds
• Builds ultra-fast image while keeping traditional OCT sensitivity

Glaucoma, cataracts or macular degeneration will be quicker and easier to diagnose thanks to a new scanner being developed to capture real-time and artefact-free eye images.
European researchers are developing a new real-time scanner that will create a full image of a moving eye without any blurring.

Teaming up with photonics innovation hub ACTPHAST 4R the scientists at Vrije Universiteit (VU) Amsterdam are progressing their scanner concept to a demonstrator stage to acquire data faster than existing optical imaging technologies.

Some degenerative eye conditions like glaucoma, diabetic retinopathy, macular holes, and retinal diseases can progress to blindness if they are not diagnosed in their early stages due to missed opportunities from poor image quality or motion artefacts.

Eye specialists currently use an imaging technique called Optical Coherence Tomography (OCT), a non-invasive test that uses light to build up an image of the retina by capturing cross-sectional ‘slices’.

However, because the eye is constantly moving, the images suffer from blurring and often only partial pictures are possible. OCT technology has never been fast enough to take a full image of a moving eye without blurring or expecting the patient to sit incredibly still.

Assistant Professor Imran Avci The lead researcher on this breakthrough development, Assistant Professor Imran Avci (left) from the Department of Physics and Astronomy at VU Amsterdam, said: “Diagnoses of eye diseases that could lead to blindness require good quality images at an early stage.

“Eye abnormalities can be so very subtle in the early phase that standard OCT can miss these tiny changes. Because our eyes are constantly moving to refresh the visual input, even at a microscopic level, it makes eye imaging very difficult without having blurred images.

“Our scanner is different: with the data acquired fast enough, the overall goal is to have a real-time imaging system. The rapid switch will enable us to perform real-time high quality moving footage, or a ‘video’ of your eye.”

Light Bundles

The scanner works by acquiring data from the light signal at rapid speeds by ‘bundling’ groups of information together.

“Our new scanner will acquire the light signal data at least hundred times quicker than OCT systems that exist today.

“Taking 100 to 120 reference points, our scanner 'bundles' them together, acquiring 20 arms at a time. However, it is our patented 'switch' that moves from bundle to bundle in nanoseconds that gives us the ability to quickly acquire the images in real-time."

A Standard OCT works by collecting data from a single sample arm, which is acquired mechanically using a scanner. The final image is formed by combining these individual images during post-processing.

“Processing each sample arm means existing technology is not fast enough to handle constant eye movement.

“We can speed up the traditional OCT imaging system while keeping its sensitivity at a reasonable value. Our imaging speed improves while the signal to noise ratio is not sacrificed too much. The faster speed makes it possible to image dynamic situations or fast-moving parts of the body, like the eye.

“The OCT we have today uses a process called ‘eye-tracking’ which can be tricky and involves many elements to do it right. However, if we can manage to create an image before the eye moves (in 5-10 sec or so) then there is no need for tracking schemes,” said Dr Avci.

ACTPHAST for Researchers

Working with ACTPHAST 4R - an EU innovation hub designed to give researchers working in academia throughout Europe access to top-level expertise and technologies in photonics to produce demonstrators for their scientific breakthroughs, similar to the supports provided by the separate ACTPHAST 4.0 innovation hub for European companies, especially for SMEs – Dr Avci’s team has been able to access the right technical and business coaching expertise to advance the scanner concept towards an actual product.

ACTPHAST 4R Coordinator, Prof Hugo Thienpont of the Brussels Photonics Team (B-PHOT) at Vrije Universiteit Brussel (VUB) said: “Researchers like Dr Avci do not have easy access to the relevant cutting-edge photonics expertise and technologies within their own universities or even their own regions.

“The ACTPHAST 4R support is crucial to bridging the gap between concept and demonstrator. Only an innovation hub like ACTPHAST 4R can provide the unique cross-border connections for bridging the innovation valley of death and accelerated TRL advancement.

“At this early stage for researchers, it means turning their scientific concepts into practical demonstrators which are cutting-edge and industrially relevant.
If the demonstrator is successful, then they can look at commercialisation options such as licensing or a spin-out company from the university, and taking it to the next stage of a working prototype”.

Dr. Avci said: “ACTPHAST 4R has been essential in helping us develop our product because it has de-risked the investment we have to make. ACTPHAST 4R has given us access to the right know-how and equipment to overcome critical photonics challenges, including the invaluable opportunities for hands-on training at the facilities of the top competence centres in the key photonics technologies for our application.

They make a huge difference to small research teams like ours”.

Specialising in the deployment of cutting-edge photonics technologies, ACTPHAST 4R gives researchers in academic institutes all over Europe the chance to turn their breakthrough scientific concepts into fully-functioning industrially-relevant demonstrators.

“As a ‘one-stop-shop’ solution for researchers innovating in photonics, ACTPHAST 4R provided rapid access to the technical specialists and cutting-edge technologies in photonics that the team needed in order to further develop the product, and also substantially funded the innovation work. The application process via the ACTPHAST 4R website was quick and easy too”.

ACTPHAST 4R operates a continuous open call for researchers who wish to apply for innovation support.

Cantor-Nissel now back at full power following the ups and downs of this year’s pandemic

November 2020

David Cantor
Now fully staffed with the need to ramp up increased production to take over the production of CooperVision’s highly successful prescribed lens, Zero 6, Cantor-Nissel look forward to further advances in specialist contact lens production.

A little about this admired company.

At Cantor-Nissel the emphasis has always been on special prescription lenses and this was aided by the acquisition of G. Nissel & Co in the year 2000. This added scleral lenses and artificial eyes to the portfolio as well as specialised animation work and the company name was changed to Cantor and Nissel Ltd, to reflect the product range of two of the oldest contact lens laboratories.

The prosthetic range of lenses was expanded by adding an extensive selection of tinted lenses to all specifications, the printed Cantor Prosthetic lens, as well as the hand painted Nissel Custom lens - international film work then followed.

Since November the company has acquired the right to produce the Zero6, whose supply was suspended by CooperVision. This daily worn lens has been a staple choice for many thousand patients fitted by contact lens practitioners throughout Europe.

Karen Hughes
Lauren Overy
Its continued supply will allow them to continue comfortable wearing, having been prescribed and recommended as a lens required for those with additional needs in regime or in its superb range of fitting and power parameters.

Its supply through Cantor-Nissel will also afford the control of supply through “Practitioner Only delivery” safeguarding patient and practitioner alike.

Contact Lenses worn daily and cleaned with much improved cleaners are yet another weapon in the armoury of eco-warriors reducing over 700 lenses being disposed often incorrectly.

New products are always being developed, the latest being an advanced mini scleral in high Dk RGP material and a high water content soft keratoconus lens, these are both expected to be launched in 2021.

The company provides the full gamut of professional advisors and key players within its organisation including its Professional Service team and its Quality Assurance and R&D teams.

Alongside 50 other incredible team members at both our Brackley & Hemel Hempstead premises, we are dedicated to providing you with both exceptional service and products.

Find out more about Zero 6 Here

1 David Cantor Chairman (Top Right)
2 The Professional Services Team headed by Karen Hughes (lower left) Professional Services Manager for ECPs and co-worker Lauren Overy (Lower right)

Lumenis Launches Digital Duet SLT-YAG Platform

November 2020

Digital Duet by Lumenis The Digital Duet, which Lumenis describes as the first digital SLT-YAG system on the market, improves glaucoma treatment and posterior capsulotomy with the introduction of advanced digital and connectivity capabilities—redefining the platform as a comprehensive solution for digital imaging, treatment and practice efficiency.

The Digital Duet streamlines workflow in the ophthalmology practice. Doctors can seamlessly generate reports and save data, images and video to the practice network and the electronic medical record, with no need for additional documentation or laser logs, according to Lumenis. The system facilitates quick, transparent communication with referring doctors, allowing practices to easily share reports and treatment documentation with the patient’s primary doctor.

Using the Digital Duet, physicians can capture digital images and video before, during and after treatment to improve diagnosis and documentation. Digital imaging also enriches education, whether a physician is showing pathology to patients or using the system’s live viewing capabilities to have multiple students watch procedures in real time.

The Digital Duet also offers state-of-the-art optics for optimal visibility of the trabecular meshwork and anterior segment. The system’s SmartV titratable on-axis/off-axis illumination improves visualization during capsulotomy and iridotomy and enhances illumination of vitreous opacities. In addition, the Digital Duet’s highly accurate super-Gaussian beam profile delivers photodisruptive effect with less energy and time, for lower optical breakdown.

“The Digital Duet’s digital imaging capabilities are allowing me to document pathologies. Also, I can now share images with my patients to help them understand their conditions and feel comfortable with therapy,” Nathan M. Radcliffe, MD, of the New York Eye and Ear Infirmary, said in a company news release. “It’s exciting to get these totally new capabilities in a system with the enhanced energy control, visualization and precision I need to achieve the outcomes I want for patients with glaucoma.”

For practices that treat retinal conditions, Lumenis also offers the unique Digital Trio configuration. This all-in-one solution includes an integrated state-of-the-art Smart532 photocoagular with SmartPulse subthreshold capabilities to ensure higher efficacy with less collateral damage.

“As the creator and leader in SLT-YAG systems, Lumenis is excited to continue our drive for innovation with the introduction of the next-generation Digital Duet,” said Lumenis CEO Tzipi Ozer-Armon. “With the Digital Duet, our company has reimagined laser therapy as a comprehensive platform with seamless digital imaging, state-of-the-art procedures, and streamlined communication. It’s a perfect reflection of our commitment to improve patients’ health through cutting-edge solutions.”

FMO Updates Members on big changes ahead for 2021

October 2020

On Thursday 22 October the FMO held their General Members’ Meeting during which Chairman Stuart Burn informed members of the exciting changes ahead to help create a reinvigorated and strengthened FMO from 2021.

Current and Honorary Life Members were invited to the virtual meeting which saw one of the largest meeting attendances in recent years.

Full information was given on two recent events which were both facilitated to help FMO members; the sale of Optrafair and subsequent collaboration with Media 10 and the marketing for sale of the office base in London.

Nathan Garnett of Media 10 gave a presentation on plans ahead of 100% Optical, due to take place in May.

Nathan revealed he and the Stuart were already developing ideas on what FMO would be adding to the exhibition. He also unveiled full plans for the May show and reiterated how much he was looking forward to working with the FMO.

There was a hugely informative presentation given by Ann Blackmore on the complex issue of the new post-Brexit rules for the Medical Devices Regulation, coming into effect on 1 January 2021.

FMO will be updating members on all aspects of this in the coming weeks and months.

Stuart then discussed with members the many changes that would be taking place from the end of this year.

The FMO Board would be looking at new member benefits, with input from members welcomed via an online survey.

There would be a potential focus on gathering marketing intelligence and statistics, creating a national optical survey, developing a CET portal as well as many other new benefits.

Said FMO Chair Stuart Burn ‘We are steering the FMO into a new and exciting direction where membership for suppliers becomes more compelling as we seek to provide new benefits befitting of todays commercial environment. This will go hand in hand with greater direct contact with ECP’s to help educate, inform and promote our organsiation.’

Dr. Andy Hepworth, FMO Vice-Chair added ‘There is still very much the FMO is able to offer our members; MDR support, optical education & market intelligence are just a handful to begin with’.

News of new Viral Treatment Trial for Covid-19 hospitalised patients

October 2020

30 Technology announces first patients enrolled in UK clinical trial (NOCoV2) for the treatment of COVID-19

Thirty Respiratory Ltd (“30 Technology”) announced today that the first patients have been enrolled in the multicentre Phase 2/3 NOCoV2 trial of its leading antiviral product, RESP301, as a treatment for patients hospitalised with COVID-19. The aims of the study are to provide an effective treatment for infection from SARS-CoV-2, the virus responsible for COVID-19, and prevent hospitalised patients from needing intensive care and assisted ventilation.

Dr Mohammed Munavvar, Consultant Chest Physician/Interventional Pulmonologist at Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK, treated one of the first patients; he said, “This is a very innovative treatment for COVID-19 and we are really pleased with the way the patient has responded. We are actively recruiting patients to the study. This novel, easy-to-administer therapy has come at a good time to deal with the second wave of the pandemic.”

Patients are given a proprietary inhaled medicine (RESP301), delivered as a fine particle mist via a portable handheld nebuliser, which reaches into the lungs and releases nitric oxide (NO) at the site of virus infection and lung inflammation.

NO is the body’s natural defence against virus infection,[1] but coronaviruses suppress the lung’s normal NO-stimulated innate immune response.[2] RESP301 replenishes the NO supply in the airways and boosts the innate immune response. It also attacks the virus directly and reduces host cell metabolism – a means by which the virus replicates in humans.[3] RESP301 has shown potent activity in the laboratory against the SARS-CoV-2 virus,[4] plus a range of other pathogenic respiratory viruses and bacteria.[5],[6],[7]

Professor Onn Min Kon, Professor of Respiratory Medicine at the National Heart and Lung Institute, Imperial College London, UK, and Principal Investigator for the NOCoV2 study, added, “We urgently need effective ways to treat this virus infection, and RESP301 is such an intuitive way of delivering nitric oxide. We are optimistic that this might be a real advance in combating this disease.”

The NOCoV2 study is treating patients in hospital with COVID-19 and aims to speed their recovery and prevent the progression to more severe forms of the disease.

Professor Chris Wood, Chief Medical Officer at 30 Technology, said, “RESP301 has shown such strong activity against COVID-19 [and influenza] that we are planning to test it in a broader patient population in primary and secondary care, including those with underlying lung disease and at risk of viral exacerbations. We are also planning prevention studies to treat groups of individuals in large communities, such as university campuses and workplaces.”

RESP301 is a liquid medication designed to release NO in a way that mimics the body’s physiological response to viral or bacterial contamination within the lungs. It is delivered to the airways as a fine particle mist via a handheld nebuliser. NO is produced widely in the human body and is our natural defence against invading organisms.1 In extensive laboratory testing, RESP301 has shown potent activity against a range of pathogenic respiratory bacteria and viruses, including SARS-CoV-2, the virus responsible for COVID-19.5-7 All the constituents in RESP301 have been thoroughly tested in humans and found to be well tolerated.[8]

The NOCoV2 clinical trial is a multicentre randomised study of a new antimicrobial medicine in patients hospitalised with COVID-19. It aims to improve the time to healing from the infection, reduce the risk of disease progression and prevent patients needing intensive care or assisted ventilation. Patients are randomised to receive either RESP301 plus standard of care or standard of care alone. The purpose is to assess the potential value of adding RESP301 to the existing treatment for the patient.

About 30 Technology
30 Technology is a privately owned biopharmaceutical company developing a proprietary NO-generating technology

Repeat of Thealoz® Duo eye drops TV Campaign

October 2020

Thealoz Drops TV Campaign
Thealoz® Duo eye drops,

Thea’s leading dry eye brand is repeating it’s successful TV advertising campaign.

The 20 second advert focuses on the symptoms dry eye sufferers experience, highlighting how Thealoz® Duo offers a unique combination of ingredients that are clinically proven* to relieve the symptoms of dry eye, without the need for preservatives.

The advert goes through the most common symptoms and why consumers need to consider a preservative free solution. The advert can be seen here

The TV ad kicks off wider Thealoz® Duo brand activity across social media and online.

Point of sale for Opticians and Pharmacies is available through the Thea Sales Team or by contacting the Thea order line.

The advert will be on air nationwide on ITV3 from October 19th for 6 weeks,.

The campaign is designed to support Thea’s pharmacy & optometry customers, who have had a tough year throughout the pandemic and also highlight dry eye to consumers on the run up to the winter season, which can often be particularly hard on your eyes.

Thea’s aim is to bring the most advanced formulations in eye care and unique preservative free products to patients.

Haag-Streit UK Announces Launch of the MR Q and MR Q Supine Laser Systems in the UK

October 2020

Haag-Streit UK (HS-UK) has announced the launch of the Meridian MR Q and MR Q supine YAG lasers in the UK.

Haag Streit Yag Laser

The MR Q is a fully-integrated YAG laser, which features the latest technology for posterior capsulotomy, pupillary membranectomy, and iridotomy.

The laser boasts outstanding usability, featuring a rapid start-up time and an easy-to-use touch-screen display, according to Haag-Streit UK. The user can choose between anterior and posterior offset on one screen, ensuring an efficient workflow. The analogue rotary knobs, such as laser power and aiming beam brightness, are located on both sides of the laser head to provide a comfortable working position for left and right-handed users.

Additionally, Haag-Streit UK has introduced the MR Q supine, a fully-integrated ophthalmic laser for supine use, designed for capsulotomy and iridotomy. This is the only laser system on the market which allows the treatment of patients who are unable to sit at a slit lamp and is ideal for paediatric and elderly patients, according to Haag-Streit UK .

The MR Q supine laser features an LCD display with simple navigation between selection buttons. Control buttons change and monitor system information and an authentication pin code is in place for safety. The ergonomic 0-210° inclinable Haag-Streit Surgical binoculars allow comfortable operation.

The Ups and The Downs of the Covid-19 Hunt for a vaccination

September 2020

We hear a lot about the 9 "phase 3" vaccination trials when they first enter that scenario and let us all hope that at least a few will succeed with the necessary ability to ramp up production. Here below is good and partially hope-calming news that it is struggle for all the best brains in the world to contend with at speed.

We publish news from First Word.

J&J’s COVID-19 Vaccine “Highly Immunogenic” in Early-Stage Testing

Interim phase 1/2a study results for Johnson & Johnson’s experimental COVID-19 vaccine JNJ-78436735 have been published online on the preprint server medRxiv, with researchers saying that a single dose was “well tolerated and highly immunogenic,” and that the findings warrant further development at the lower dose level of 5×1010 viral particles (vp). The release of the early-stage data follows Johnson & Johnson’s recent announcement that it was advancing the vaccine into a phase 3 study targeting enrollment of 60,000 volunteers to test a single-dose regimen versus placebo.

The company said it is also planning to run a parallel phase 3 trial of a two-dose regimen of JNJ-78436735 versus placebo later this year. “The [interim analysis] data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants,” Johnson & Johnson stated, adding that “immune responses were similar across the age groups studied, including older adults.”

Johnson & Johnson initiated the phase 1/2a placebo-controlled study of JNJ-78436735, also known as Ad26.COV2.S, at the end of July. The vaccine, a non-replicating adenovirus 26 vector expressing the stabilised pre-fusion spike (S) protein of SARS-CoV-2, was administered at a dose level of 5×1010 vp or 1×1011 vp per vaccination, either as a single dose or as a two-dose schedule spaced by 56 days in healthy adults.

Cohorts 1a and 1b included 402 participants from 18 to 55 years old, while cohort 3 enrolled 394 elderly participants over 65. The interim analyses were performed after the first dose of blinded safety data from cohorts 1a, 1b and 3, and group unblinded immunogenicity data from cohort 1a and 3.

Immune responses

SARS-CoV-2 neutralizing antibody titers were measured by wild-type virus neutralization assay (wtVNA). Researchers reported that after a single dose, the seroconversion rate in wtVNA at day 29 in cohort 1a already reached 92% with geometric mean titers (GMT) of 214, and 92% with GMTs of 243, for the lower and higher dose levels, respectively. Similar results were seen in the first 15 participants of cohort 3, where 100% seroconversion with GMTs of 196 were observed for the 5×1010 vp dose group, and 83% seroconversion with GMTs of 127 were seen at the 1×1011 vp dose level.

Seroconversion for S antibodies was observed in 99% of cohort 1a participants, with GMTs of 528 and 695 for the lower and higher doses, respectively, and in 100% of cohort 3 subjects, with GMTs of 507 and 248, respectively. Further, on day 14 post immunization, CD4+ Th1 immune responses were measured in 80% and 83% of a subset of participants in cohort 1a and 3, respectively, with no or very low Th2 responses. The researchers noted that CD8+ T cell responses were also “robust” in cohorts 1a and 3, at both dose levels.

Safety findings

As some participants have not yet received the planned second dose, the safety data included in this analysis were presented without disclosing the assignment of vaccine versus placebo.

In cohorts 1 and 3, solicited systemic adverse events were reported in 64% and 36% of participants, respectively. Fevers occurred in both cohorts 1 and 3 at rates of 19% and 4%, respectively, and were mostly mild or moderate, resolving within one to two days. The most frequent local adverse event (AE) was injection-site pain, while the most frequent solicited AEs were fatigue, headache and myalgia. No grade 4 AEs, either solicited or unsolicited, were reported in any cohort, and no one discontinued the study due to an AE.

There were two serious AEs, including one case of hypotension judged by the investigator not to be vaccine-related because of a past history of recurrent hypotension. Meanwhile, another participant with fever was hospitalized overnight because of suspicion of COVID-19, but the individual recovered within 12 hours, and the fever was subsequently judged by the investigator to be vaccine-related.

The researchers noted that while reactogenicity was acceptable in all groups, “there was a trend for higher reactogenicity with the higher vaccine dose and with younger age.”

And as a balance the Inovio’s COVID-19 Vaccine Candidate INO-4800 is hit by a FDA Partial Hold

Inovio Pharmaceuticals said that the FDA placed a partial clinical hold on a planned phase 2/3 study of its COVID-19 vaccine candidate INO-4800.

According to Inovio, the FDA has “additional questions” about the planned trial, including the CELLECTRA 2000 delivery device to be used in the study. The drugmaker noted that it is working to address the issues and plans to respond to the agency in October.

Unrelated to adverse events

Inovio noted that the FDA’s move is not due to the occurrence of any adverse events related to the ongoing phase 1 study of INO-4800, which is not impacted by the partial hold. Earlier this year, the company reported interim phase 1 data indicating that INO-4800 was “deemed safe and well-tolerated” through 8 weeks, but did not give any details about participants’ antibody response. Inovio later announced that the DNA vaccine was “effective” at protecting non-human primates from live virus challenge 13 weeks after the last vaccination, with results “mediated by memory T and B cell immune responses.”

FDA is increasingly erring to the side of caution.

Cantor analyst Charles Duncan suggested the delay creates a “management credibility challenge” for Inovio. He also said the FDA “appears increasingly cautious on COVID-19 vaccine programs,” pointing to recent reported plans by the agency to increase the number of severe cases of the disease needed to show efficacy, as well as the prudence with which it is handling a hold on AstraZeneca’s coronavirus vaccine trial, which has resumed in other countries, but not in the US.

1 October 2020 VAT changes for Opticians, more of a simplification than radical change

September 2020

Very little has changed since the original business briefing on VAT accounting for Optical and Hearing practices co-written by Shaun King (then,Ernst Young) and Bob Hutchinson (Past Chair FODO) on behalf of the profession.

Bob Hutchinson, (Eros Business Consulting Ltd) comments on these changes:

“In the processes with effect from October 1st there is little relative change to policy except that businesses will no longer be required to seek prior approval for a Full Cost Apportionment method before its use.”

It also clarifies the requirements for those using the “Separately Disclosed Charges “Method.
These (SDC ) appear unchanged still stressing the need for separate disclosure being imparted on the till receipt for the dispensing charge separate to the professional fee and the other items and that a  requirement to show information is conveyed to them. Which I assume means some form of notices around the practice.”

From the Policy paper:

From 1 October 2020, the processes will be simplified.

There is currently no uniform standard of evidence required from businesses to show that they are making separately disclosed charges. Businesses will be required only to hold a till slip or similar evidence to demonstrate that they are making two separate charges to the customer at the time of supply, and that this information is being conveyed to the customer.
Those using a method of apportionment will no longer have to seek prior approval from HMRC before operating a method. This will bring opticians and dispensers of hearing aids into line with other businesses that apportion VAT on their sales.

Read the full guidance.

Bob Hutchinson, who continues to provide advice and  liaison between optical business and local HMRC officers further commented,” Whilst the ability to commence an FCA methodology without prior approval is welcomed I strongly suggest that practices take advice and investigate a fair FCA rate for apportionment as proof that the figure used is considered fair and reasonable by an HMRC approved agent. This provides a solid argument should a local officer disagree with an apportion rate, be it for contact lenses, spectacles or hearing aid supply.”

“This initial process also allows for a system of de minimis checking and advice to be put into place and an understanding of the dangers of excessive exempt purchases being made. Excesses in Exempt VAT on purchases can be very expensive to a business losing the right to reclaim such VAT.
The additional clarity that this paper provides is a welcome steer for us as advisors but bears no real change to the requirements.”

Link to Eros Business Consulting Ltd

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