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Opchat Magazine Industry NewsIndustry News, October to December 2020







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


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:

4. 
Changes
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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