AbbVie has announced that NICE has issued a final appraisal document recommending the dexamethasone intravitreal implant – also known as Ozurdex – as a treatment option within the NHS, for adults with visual impairment caused by diabetic macular oedema (DMO).

It is specifically aimed at individuals whose condition has not responded well enough to non-corticosteroid therapy. Until now, use of Ozurdex within the NHS has only been available to these patients if they had an artificial lens. The recommendation from NICE, however, extends use of the implant to include those with a natural lens and means that suitable patients will now have access to an additional treatment beyond non-cortiocosteroid therapy.

DMO is a complication of diabetes that affects approximately 7% of 3.5 million people with the condition in England. It is also one of the leading causes of preventable sight loss in the UK. Current non-corticosteroid therapies for DMO include laser therapy and anti-vascular endothelial growth factor (anti-VEGF) injections.

“The availability of an additional treatment, which can help patients with diabetic macular oedema retain vision, is very welcome news,” explained Cathy Yelf, chief executive of the Macular Society. “The potential it offers for fewer injections and hospital visits for those currently receiving but not responding to anti-VEGF injections, could also make a difference to the lives of those living with DMO, and their families.”

Verona Pharma has announced its top-line phase 3 ENHANCE-2 trial results evaluating nebulised ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

The trial has successfully met its primary endpoint, as well as secondary endpoints, demonstrating improvements in lung function and a significantly reduced risk of COPD exacerbations.

Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4, combining bronchodilator and anti-inflammatory activities in a single compound.
The study, which involved over 700 participants, showed statistically significant and clinically meaningful improvements with ensifentrine. This included gender, age, smoking status, COPD severity, background medication, chronic bronchitis and FEV1 reversibility subgroups.

Subjects receiving ensifentrine also demonstrated a 42% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks compared to those receiving placebo. Furthermore, treatment with the therapy significantly decreased the risk of a moderate or severe exacerbation as measured by time to first exacerbation when compared with placebo.

David Zaccardelli, Verona’s chief executive officer, concluded: “We are very pleased by the successful outcome of our ENHANCE-2 study and remain committed to bringing ensifentrine to COPD patients as quickly as possible. We want to thank all the patients and investigators for their participation in the trial to advance ensifentrine as a potential new therapy for the treatment of COPD.”

Advanced Accelerator Applications – a Novartis company – has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation in Britain for Pluvicto.

The therapy – also known as lutetium vipivotide tetraxetan – treats adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.

It follows the positive scientific opinion issued in April 2022 by the MHRA for the Early Access to Medicines Scheme.

Radioligand therapy (RLT) is an emerging treatment approach that may offer an alternative treatment option for some cancer patients. RLT is administered via the bloodstream and delivers targeted radiation to cancer cells in the body, with the goal of limiting damage to surrounding tissue.

Steve Allen, acting chair of Tackle Prostate Cancer, reflected: “Far too many people are still dying each year from prostate cancer. Tragically, those diagnosed with metastatic prostate cancer will only have about a one in two chance of surviving five years. The announcement of marketing authorisation for lutetium treatment is another positive milestone for eligible patients and their families.”