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The new Trump administration’s directive that federal employees return to the office full time will drive away skilled professionals who are protecting the aviation system from terrorist threats, a former Transportation Security Administration official warned Friday.
Douglas Brittin, who headed the TSA’s air cargo division a decade ago, said in a letter to the House Homeland Security Committee that the the mandate to phase out remote work without sufficient planning or accommodation will lead to “significant attrition, including the loss of irreplaceable institutional knowledge and expertise” and undermine the agency’s ability to recruit and retain specialized personnel.
A self-inflicted brain drain would hurt current air cargo security programs, such as third-party canine inspections, as well standard security screening processes and adoption of new screening technologies for passenger checkpoints and cargo, that the TSA is working to upgrade and improve with the Airforwarders Association and other industry stakeholders, Brittin said.
“Losing experienced personnel during these important initiatives will jeopardize their success and, by extension, our national security,” he said.
Aviation remains a high-profile target for terrorists and rogue nations. Air cargo security recently came under scrutiny after Western intelligence agencies alleged Russia’s military intelligence unit was behind a plot to smuggle booby-trapped incendiary devices onto DHL Express cargo jets in Europe last summer. The packages caught fire on the ground at DHL’s air facility in Leipzig, Germany, and a logistics hub in Birmingham, United Kingdom. U.S. and European security officials say they believe the parcel bombs were a test run for future attacks against U.S.-bound aircraft.
Skilled professionals experienced at security operations, planning and risk mitigation are needed to address such threats to cargo and passenger security, Brittin stressed.
He urged Chairman Mark Green, R-Tenn., and ranking member Bennie Thompson, D-Miss., to press the administration to extend the return-to-office deadline by six months for key divisions such as air cargo and canine inspections so the TSA can retain talent and ensure program continuity.
President Trump last week signed an executive order instructing agencies to stop remote work practices and directing workers to return to their desks. A subsequent directive from the Office of Personnel Management provides details on how agency heads are to implement the return to in-person work. Trump campaigned on a platform of increasing federal workforce efficiency and accountability. According to the administration, telework has resulted in empty offices, diminished performance and challenges in supervision and training.
Many federal workers disagree that they aren’t working hard or doing quality work for taxpayers.
The previous rules allowed subject-matter experts to build careers on flexible work arrangements and TSA to recruit and retain specialized personnel, according to Brittin.
He added that the recent relocation of TSA’s headquarters from Arlington, Virginia — across the Potomac River from downtown Washington, D.C. — to Springfield, Virginia, makes it more difficult to house an influx of workers. “The new facility lacks the capacity to accommodate the volume of personnel currently teleworking, making the return-to-office transition logistically impractical and likely to create an untenable work environment,” Brittin said.
Homeland Security advisory committees put on freeze
The security situation, he added, is also undermined by the recent departure of the Air Cargo Division director and the vacancy left by Trump’s firing of TSA Administrator David Pekoske. The deputy administrator’s position at TSA is also vacant.
Ben Currier served as executive director of TSA’s air cargo security division until his abrupt departure three weeks ago to take a position at the Department of Defense. His successor has yet to be named.
Meanwhile, the Department of Homeland Security has effectively suspended the operation of key federal advisory committees involved in aviation and cross-border freight security. Private-sector members of the Aviation Security Advisory Committee (ASAC) and the Commercial Operations Advisory Committee (COAC), which supports Customs and Border Protection, were advised in a Jan. 20 memo from then-DHS Acting Secretary Benjamine Huffman that the department is revoking membership in all advisory committees as part of a “commitment to eliminating the misuse of resources and ensuring that DHS activities prioritize our national security.” The Federal Railroad Administration also has an advisory committee.
The ASAC was mandated by Congress in 1988 after the PanAm 103 bombing. Congress also established COAC.
The decision on the TSA’s advisory body “eliminates a vital platform for collaboration between government and industry stakeholders, undermining efforts to safeguard the flying public and protect our nation’s commerce,” the Airforwarders Association said in a statement. “Disbanding this committee at such a critical time weakens our collective ability to respond to evolving threats. We urge the President and his administration to reconsider this decision immediately and reinstate ASAC as an essential advisory body.”
Marianne Rowden, CEO of the E-Merchants Trade Council, said via email that by cancelling current membership, “the Trump Administration may be evaluating the mission of advisory committees and whether they match the priorities that the President has set for each agency while gauging the resources to staff the advisory committees.”
In a recent development, the Trump administration’s decision to reverse telework policies for aviation security employees has raised concerns about the potential impact on the safety and security of air travel. According to a former TSA official, this move undermines the effectiveness of security measures in place to protect passengers and prevent potential threats.
Telework has been a longstanding practice within the Transportation Security Administration (TSA), allowing employees to work remotely and maintain a flexible schedule. This flexibility has been instrumental in ensuring that security personnel are able to respond quickly to changing threats and maintain a high level of vigilance at airports across the country.
However, the Trump administration’s decision to eliminate telework options for TSA employees has been met with criticism from security experts and industry professionals. According to the former TSA official, this reversal will disrupt the continuity of operations and reduce the overall effectiveness of security measures at airports.
In a statement, the former official emphasized the importance of maintaining a strong telework program for aviation security personnel, highlighting the crucial role that remote work plays in ensuring the safety and security of air travel. The decision to eliminate telework options, he argued, will only serve to weaken security protocols and put passengers at risk.
As the debate over telework policies continues, it is clear that the Trump administration’s reversal has significant implications for aviation security. Industry experts are calling for a reconsideration of this decision in order to ensure the continued safety and security of air travel.
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In a rare public rebuke, a senior Taliban figure has called on the group’s leadership to end the ban on education for women and girls in Afghanistan.
Afghan foreign ministry political deputy Sher Abbas Stanikzai made the remarks in a speech on Saturday in south-eastern Afghanistan’s Khost province.
He told an audience at a religious school ceremony there was no reason to deny education to women and girls, “just as there was no justification for it in the past and there shouldn’t be one at all”.
The Taliban has banned women from higher education at institutions like Kabul University. (Reuters: Sayed Hassib)
Mr Stanikzai asserted the ongoing prohibition against female education had no religious justification.
“We are committing an injustice against 20 million people out of a population of 40 million, depriving them of all their rights,” Mr Stanikzai said in a video shared by his official account on social media.
“This is not in Islamic law, but our personal choice or nature.”
Comments dismissed as bid to ‘rebrand’ Taliban
Mr Stanikzai was once the head of the Taliban team in talks that led to the complete withdrawal of foreign troops from Afghanistan.
It is not the first time he has said that women and girls deserve an education.
He made similar remarks in September 2022, a year after schools closed for girls and months before the introduction of a university ban.
Activists have warned that true progress can only come when there is the full restoration of women’s rights in Afghanistan. (AP: Ebrahim Noroozi/File)
“We call on the leadership again to open the doors of education,” he said, marking the first call for a change in policy and a direct appeal to Taliban leader Hibatullah Akhundzada.
However, Afghan women’s rights advocates warned against viewing it as a turning point.
Zubaida Akbar, an activist with the women’s human rights organisation Femena, said the remarks were likely a strategic move to bolster credibility for the Taliban internationally.
“The Taliban deputy’s remarks about there being no excuse for the education bans on Afghan women and girls reflects desperation,” Ms Akbar told the ABC.
“They think making these statements is a strategic move to rebrand themselves as progressive.”
Deputy Foreign Minister Sher Mohammad Abbas Stanikzai is often criticised by his peers for advocating for women’s rights. (Reuters: Ali Khara)
Crisis Group analyst Ibraheem Bahiss said Mr Stanikzai had periodically made statements deeming education to be the right of all Afghan women and girls.
“However, this latest statement seems to go further in the sense that he is publicly calling for a change in policy and questioned the legitimacy of the current approach,” Mr Bahiss said.
Susan Hutchinson, executive director of the NGO Azadi-e Zan (Free Woman), who has helped several women’s rights defenders from Afghanistan, said Mr Stanikzai’s comments alone are not enough to lead to a lift in the ban.
“Mr Stanikzai is one of the more progressive of the Taliban leaders and is often criticised by his peers for his stand on women’s freedoms,” Ms Hutchinson explained.
“The lack of educational access is a serious issue for the Afghan economy and overall welfare of the country,” she added.
Pressure on Taliban regime over denial of women’s rights
No country recognises the Taliban as the legitimate rulers of Afghanistan, but countries like Russia have been building ties with them.
India has also been developing relations with Afghan authorities.
Nobel Peace laureate Malala Yousafzai has called on the international community to speak out against the Taliban’s ban on women and girls’ education.
In Dubai this month, a meeting between India’s top diplomat, Vikram Mistri, and Foreign Minister Amir Khan Muttaqi showed their deepening cooperation.
The United Nations has said that recognition of the Taliban government is almost impossible while bans on female education and employment remain in place and women can’t go out in public without a male guardian.
Nobel Peace Prize laureate Malala Yousafzai this month told a conference hosted by the Organisation of Islamic Cooperation and the Muslim World League that Islamic leaders should challenge the Taliban on women and girls’ education.
Ms Akbar highlighted the broader repression under the Taliban including banning women from work, singing or being heard in public.
“Access to education is not meaningful progress if women cannot freely move, speak, or participate in public life,” Ms Akbar said.
She called on the international community to remain vigilant against attempts to use partial reforms to win legitimacy.
“The Taliban negotiator’s statements appear to be a calculated effort to present an image of reform within their ranks.”
Some activists warn that the Taliban’s statements may be a calculated effort to present an image of reform. (Save the Children: Holly Robertson)
A statement on behalf of Ambassador Wahidullah Waissi of the Islamic Republic of Afghanistan in Canberra to the ABC echoed these sentiments.
“Restoring girls’ access to education — an essential and fundamental human right —requires more than superficial policy changes or public discourse; it demands a transformative shift in attitudes to undo the deep damage caused by their oppressive actions,” said the statement.
Since the Taliban’s forced takeover in August 2021, the Embassy of the Islamic Republic of Afghanistan in Canberra has continued to fulfill its diplomatic responsibilities under the Vienna Convention on Diplomatic Relations of 1961, operating independently of Taliban influence.
The Taliban has increasing added restrictions on women since taking power. (Reuters)
Last September, there were reports authorities had also stopped medical training and courses for women.
In Afghanistan, women and girls can only be treated by female doctors and health professionals.
Authorities have yet to confirm the medical training ban.
ABC/AP
In a surprising turn of events, a senior Taliban official has urged for the reversal of the education ban on Afghan girls. This comes as a welcomed change from the group’s strict policies that have oppressed women and girls for years.
The official, whose identity has not been disclosed, emphasized the importance of education for all Afghan citizens, regardless of gender. They stated that education is a fundamental human right and should not be denied to anyone.
This statement has sparked hope among many in Afghanistan, especially parents and activists who have been fighting for girls’ education for years. It remains to be seen how this will be implemented on the ground, but it is a step in the right direction towards gender equality and empowerment.
It is encouraging to see a shift in mindset within the Taliban leadership, and hopefully, this will lead to positive changes for Afghan girls and women in the future. Let’s continue to advocate for equal opportunities for all, regardless of gender.
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Taliban official calls for end to education ban on Afghan girls
Senior Taliban leader advocates for reversal of girls’ education prohibition
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Senior Taliban member pushes for change in policy on girls’ schooling
Taliban official urges lifting of ban on education for Afghan girls
Reversing the ban: Senior Taliban leader’s plea for girls’ education in Afghanistan
Senior Taliban official calls for reevaluation of policy on girls’ schooling
Afghan girls’ education rights advocated by senior Taliban figure
Taliban leader speaks out against ban on education for Afghan girls
Senior Taliban official demands action on girls’ education ban in Afghanistan
Akero Therapeutics (NASDAQ: AKRO) has announced significant topline results from its Phase 2b SYMMETRY study evaluating efruxifermin (EFX) in patients with compensated cirrhosis due to MASH. The study demonstrated statistically significant reversal of cirrhosis at Week 96:
– Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group showed ≥1 stage improvement in fibrosis with no worsening of MASH, compared to 15% for placebo (24% effect size).
– In the Intent to Treat analysis, 29% of the 50mg EFX group demonstrated improvement, compared to 12% for placebo (17% effect size).
The study revealed stronger results in patients not taking GLP-1 at baseline, with 45% showing cirrhosis reversal in the 50mg group versus 17% for placebo. EFX was generally well-tolerated, with most adverse events being grade 1 or 2 gastrointestinal issues.
Akero Therapeutics (NASDAQ: AKRO) ha annunciato risultati preliminari significativi dal suo studio di Fase 2b SYMMETRY che valuta efruxifermin (EFX) in pazienti con cirrosi compensata dovuta a MASH. Lo studio ha dimostrato una significativa inversione della cirrosi alla Settimana 96:
– Tra i pazienti con biopsie alla baseline e alla settimana 96, il 39% del gruppo EFX a 50mg ha mostrato un miglioramento di almeno 1 stadio nella fibrosi senza deterioramento della MASH, rispetto al 15% per il placebo (dimensione dell’effetto del 24%).
– Nell’analisi Intent to Treat, il 29% del gruppo EFX a 50mg ha dimostrato miglioramenti, rispetto al 12% per il placebo (dimensione dell’effetto del 17%).
Lo studio ha rivelato risultati più forti nei pazienti che non assumevano GLP-1 alla baseline, con il 45% che mostrava inversione della cirrosi nel gruppo a 50mg rispetto al 17% per il placebo. L’EFX è stato generalmente ben tollerato, con la maggior parte degli eventi avversi che si sono manifestati come problemi gastrointestinali di grado 1 o 2.
Akero Therapeutics (NASDAQ: AKRO) ha anunciado resultados preliminares significativos de su estudio de Fase 2b SYMMETRY, que evalúa el efruxifermin (EFX) en pacientes con cirrosis compensada debida a MASH. El estudio demostró una reversión estadísticamente significativa de la cirrosis a la Semana 96:
– Entre los pacientes con biopsias en la línea base y en la semana 96, el 39% del grupo EFX de 50mg mostró una mejora de al menos 1 estadio en la fibrosis sin empeoramiento de MASH, en comparación con el 15% para el placebo (tamaño del efecto del 24%).
– En el análisis por intención de tratar, el 29% del grupo EFX de 50mg demostró mejora, en comparación con el 12% para el placebo (tamaño del efecto del 17%).
El estudio reveló resultados más sólidos en pacientes que no tomaban GLP-1 en la línea base, con un 45% mostrando reversión de la cirrosis en el grupo de 50mg frente al 17% para el placebo. El EFX fue generalmente bien tolerado, con la mayoría de los efectos adversos siendo problemas gastrointestinales de grado 1 o 2.
Akero Therapeutics (NASDAQ: AKRO)는 MASH로 인한 보상성 간경변증 환자를 대상으로 efruxifermin (EFX)의 2b 상기 SYMMETRY 연구에서 중요한 상위 결과를 발표했습니다. 이 연구는 96주에서 간경변증의 통계적으로 유의미한 역전을 보여주었습니다:
– 기저선 및 96주 생검이 있는 환자 중에서 50mg EFX 그룹의 39%가 MASH의 악화 없이 섬유화의 ≥1단계 개선을 보였으며, 이는 위약의 15%보다 높습니다 (효과 크기 24%).
– 치료 의도 분석에서는 50mg EFX 그룹의 29%가 개선을 보여주어, 위약의 12%에 비해 (효과 크기 17%) 개선되었습니다.
이 연구는 기저선에서 GLP-1을 복용하지 않은 환자에서 더 강한 결과를 보였으며, 50mg 그룹에서 간경변증이 역전된 비율은 45%, 위약군은 17%였습니다. EFX는 일반적으로 잘 견디며, 대부분의 이상반응은 1도 또는 2도의 위장 문제로 나타났습니다.
Akero Therapeutics (NASDAQ: AKRO) a annoncé des résultats préliminaires significatifs de son étude de Phase 2b SYMMETRY évaluant l’efruxifermin (EFX) chez des patients atteints de cirrhose compensée due à MASH. L’étude a montré une inversion statistiquement significative de la cirrhose à la Semaine 96 :
– Parmi les patients ayant subi des biopsies à la base et à la semaine 96, 39% du groupe EFX à 50mg ont montré une amélioration d’au moins 1 stade dans la fibrose sans aggravation de MASH, par rapport à 15% pour le placebo (taille de l’effet de 24%).
– Dans l’analyse des intentions de traitement, 29% du groupe EFX à 50mg ont démontré une amélioration, par rapport à 12% pour le placebo (taille de l’effet de 17%).
L’étude a révélé des résultats plus solides chez les patients ne prenant pas de GLP-1 à la base, avec 45% montrant une inversion de la cirrhose dans le groupe à 50mg contre 17% pour le placebo. L’EFX a généralement été bien toléré, la plupart des effets indésirables étant des problèmes gastro-intestinaux de grade 1 ou 2.
Akero Therapeutics (NASDAQ: AKRO) hat bedeutende vorläufige Ergebnisse aus seiner Phase-2b-Studie SYMMETRY veröffentlicht, die efruxifermin (EFX) bei Patienten mit kompensierter Zirrhose aufgrund von MASH bewertet. Die Studie zeigte eine statistisch signifikante Umkehrung der Zirrhose in Woche 96:
– Unter den Patienten mit Biopsien zu Beginn und in Woche 96 zeigten 39% der EFX-Gruppe mit 50mg eine Verbesserung um mindestens 1 Stadium in der Fibrose, ohne eine Verschlechterung von MASH im Vergleich zu 15% für das Placebo (Effektgröße von 24%).
– In der Analyse der Behandlungsabsicht demonstrierten 29% der EFX-Gruppe mit 50mg eine Verbesserung im Vergleich zu 12% für das Placebo (Effektgröße von 17%).
Die Studie ergab stärkere Ergebnisse bei Patienten, die zu Beginn kein GLP-1 einnahmen, wobei 45% in der EFX-Gruppe eine Umkehrung der Zirrhose zeigten im Vergleich zu 17% für das Placebo. EFX wurde im Allgemeinen gut vertragen, wobei die meisten unerwünschten Ereignisse Grad 1 oder 2 gastrointestinale Probleme waren.
Positive
Statistically significant reversal of cirrhosis in 39% of 50mg EFX group (p=0.009)
More than doubling of effect size from weeks 36 to 96 in 50mg group (10% to 24%)
45% cirrhosis reversal rate in non-GLP-1 patients with 50mg EFX
Favorable safety profile with no drug-related serious adverse events
Negative
Presence of gastrointestinal adverse events (diarrhea, nausea)
Lower efficacy in ITT analysis (29%) compared to completer analysis (39%)
Insights
The SYMMETRY trial results represent a potential watershed moment in MASH treatment. The 39% cirrhosis reversal rate in the 50mg EFX group (p=0.009) is unprecedented in the field of liver disease therapeutics. Even the more conservative ITT analysis showed a 29% response rate (p=0.031), maintaining statistical significance.
Several aspects make these results particularly compelling:
The doubling of effect size from weeks 36 to 96 (10% to 24%) suggests increasing benefits with longer treatment duration – critical for a chronic condition like MASH
The subgroup analysis excluding GLP-1 users showed an even more robust 45% response rate, differentiating EFX’s mechanism from popular weight-loss drugs
The biomarker data strongly supports the histological findings – particularly the 0.53-point reduction in ELF score and 24% reduction in liver stiffness for the 50mg group
The safety profile appears manageable, with primarily Grade 1-2 gastrointestinal events and no treatment-related serious adverse events. This favorable benefit-risk profile is important for a drug targeting chronic use in a large patient population.
These results are particularly significant given that compensated cirrhosis represents the most severe form of MASH before decompensation, where mortality risk increases dramatically. The ability to reverse cirrhosis could fundamentally alter the disease trajectory for these high-risk patients.
The SYMMETRY results position EFX as a potential first-in-class therapy for MASH cirrhosis, addressing a critical unmet need in a market with no approved treatments. The robust efficacy data, particularly in cirrhosis reversal, could support premium pricing and favorable reimbursement decisions.
Key market implications:
First-mover advantage in the high-value cirrhotic MASH segment, where patients face significant mortality risk
Differentiated positioning from GLP-1s, supported by superior efficacy in non-GLP-1 users (45% response rate)
Strong safety profile supporting chronic use, critical for market adoption and payer acceptance
Multiple supportive biomarkers that could facilitate real-world monitoring of treatment response
The data’s strength could support broad label claims and favorable positioning in treatment guidelines. The demonstrated benefits in cirrhosis reversal could justify premium pricing, particularly given the high costs associated with liver transplantation and complications of advanced liver disease.
Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group (p=0.009) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 24% effect size over placebo at 15%
By ITT analysis, with all missing week 96 biopsies treated as failures, 29% of the 50mg EFX group (p=0.031) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 17% effect size over placebo at 12%
Investor webcast at 8:00 am ET Monday, January 27, 2025
SOUTH SAN FRANCISCO, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today released preliminary topline week 96 results from SYMMETRY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH). Among patients with baseline and week 96 biopsies (n=134), 39% of patients treated with 50mg EFX (n=46) (p=0.009) experienced reversal of cirrhosis with no worsening of MASH, compared to 15% for placebo (n=47). In the Intent to Treat (ITT) population (n=181), with all missing week 96 biopsies treated as failures, 29% of patients in the 50mg EFX group (n=63) (p=0.031) experienced reversal of cirrhosis with no worsening of MASH, compared to approximately 12% in the placebo group (n=61).
With more than a doubling of effect size from weeks 36 to 96 in the 50mg group (from 10% to 24%), the SYMMETRY study underscores the benefit of longer EFX treatment for patients with compensated cirrhosis (F4).
In a subgroup of patients with baseline and week 96 biopsies who were not taking GLP-1 at baseline (n=97), 45% in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH (n=29) (p=0.009) compared to 17% for placebo (n=36), suggesting that the observed reversal of cirrhosis was not attributable to GLP-1 therapy.
“Until today, we’ve not had the prospect of an effective treatment for compensated cirrhosis due to MASH, which is associated with high rates of short-term morbidity and mortality,” said Mazen Nourredin, M.D., Professor of Medicine and Transplant Hepatologist at Houston Methodist Hospital, and principal investigator for the SYMMETRY study. “Now we have reason to be optimistic about the future potential of EFX as a much-needed treatment for cirrhosis, if approved. I’m so happy for my patients and patients all around the world.”
Summary of Week 96 Reversal of Cirrhosis Endpoint
Primary Analysis (N=134)1
ITT Analysis (N=181)2
Histology Endpoint3 (Proportion of Patients)
Placebo (N=47)
28mg (N=41)
50mg (N=46)
Placebo (N=61)
28mg (N=57)
50mg (N=63)
≥1 stage fibrosis improvement without worsening MASH (%)
15
29
39 **
12
21
29 *
1 All patients with baseline and week 96 biopsies 2 The 47 randomized and dosed patients who had missing biopsies at week 96 are treated as failures in the ITT analysis (without imputation) 3 Biopsies scored independently by two pathologists; third available to adjudicate (which was not required) * p<0.05, ** p<0.01, versus placebo (Cochran-Mantel-Haenszel test (CMH))
“We believe today’s first-ever public report of reversal of cirrhosis due to MASH, whether by completer or ITT analysis, sets EFX apart from other approved or investigational treatments in the MASH landscape as a compound with transformational potential,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “We look forward to continuing evaluation of 50mg EFX in our ongoing Phase 3 SYNCHRONY Outcomes study in patients with compensated cirrhosis due to MASH.”
The reversal of cirrhosis, as quantified by a consensus of two histopathologists, is supported by improvements in noninvasive measures of liver fibrosis and injury.
Summary of Week 96 Changes in Key Noninvasive Measures of Liver Fibrosis and Injury
Measure
(LS Mean Change From Baseline to Week 96)
Placebo (n=49)
28mg (n=40-41)
50mg (n=47)
ELF Score
+0.22
-0.34 ***
-0.53 ***
Liver Stiffness (%) (FibroScan)
-8
-18
-24 *
ALT (U/L)
-6.8
-10.5
-11.1
AST (U/L)
-1.6
-8.1
-11.2 **
* p<0.05, *** p<0.001, versus placebo (MMRM)
EFX was reported to be generally well-tolerated. There were no deaths on EFX, but one death in the placebo arm due to pneumonia. None of the Serious Adverse Events were determined to be related to study drug. Across both EFX groups, the most frequent adverse events (AEs) were grade 1 or 2, gastrointestinal in origin (diarrhea, nausea, and increased appetite) and transient in nature.
Conference Call / Webcast Details Akero will host a conference call and webcast with slide presentation at 8:00 a.m. ET today. The live webcast will be available on the Events & Presentations page of Akero’s website, with the recording and presentation available immediately following the event.
About Cirrhosis Due to MASH Cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis) is a life-threatening disease with high risk of liver failure, cancer and eventually death. By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, which is the fastest growing cause of liver transplants and liver cancer in the United States and Europe.
About the SYMMETRY Study The Phase 2b SYMMETRY study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH. The study enrolled a total of 182 patients, randomized to receive once-weekly subcutaneous dosing of 28mg or 50mg EFX, or placebo for 36 weeks, 181 of whom received at least one study dose. The primary efficacy endpoint for the study was the proportion of patients who achieve at least one-stage fibrosis improvement without worsening of MASH at week 36. Week 96 secondary measures included ≥1 stage fibrosis improvement and no worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, glycemic control, and lipoproteins, as well as safety and tolerability measures.
About EFX Efruxifermin (EFX), Akero’s lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
About Akero Therapeutics Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero’s lead product candidate, EFX, is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic MASH (F2-F3 fibrosis), SYNCHRONY Outcomes in patients with compensated cirrhosis due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (Metabolic Dysfunction Associated Steatotic Liver Disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and X for more information.
Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero’s business plans and objectives, including future plans or expectations for EFX and ongoing clinical studies, the therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; and the future potential of EFX following the preliminary topline week 96 results of Akero’s Phase 2b SYMMETRY study, which are subject to audit and verification procedures and additional data that could result in material changes in the final data. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include:; the success, cost, and timing of Akero’s product candidate development activities and planned clinical trials; Akero’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in Akero’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero’s other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
What were the main results of Akero’s (AKRO) SYMMETRY Phase 2b study at Week 96?
The study showed 39% of patients in the 50mg EFX group achieved cirrhosis reversal compared to 15% for placebo, with a 24% effect size in patients with baseline and week 96 biopsies.
How did EFX perform in the Intent to Treat (ITT) analysis for AKRO’s SYMMETRY trial?
In the ITT analysis, 29% of patients in the 50mg EFX group showed cirrhosis reversal compared to 12% in placebo, representing a 17% effect size.
What were the safety results for EFX in Akero’s (AKRO) Phase 2b SYMMETRY study?
EFX was generally well-tolerated with no deaths and no drug-related serious adverse events. Most common side effects were grade 1 or 2 gastrointestinal issues.
How did non-GLP-1 patients respond to EFX treatment in AKRO’s SYMMETRY trial?
Non-GLP-1 patients showed better results, with 45% in the 50mg EFX group achieving cirrhosis reversal compared to 17% for placebo.
Exciting news has emerged from Akero Therapeutics as their experimental drug, EFX, has demonstrated a remarkable 39% reversal of cirrhosis in patients with non-alcoholic steatohepatitis (NASH) in a Phase 2b trial.
Cirrhosis, a late-stage liver disease characterized by scarring and loss of liver function, is a major complication of NASH, a condition often associated with obesity and metabolic syndrome. Currently, there are limited treatment options for NASH and cirrhosis, making Akero’s findings particularly promising.
The results of the trial, known as the MASH study, showed that patients treated with EFX experienced a significant reduction in liver fibrosis and improvement in liver function compared to those receiving a placebo. Additionally, EFX was well-tolerated by patients, with no serious adverse events reported.
These findings represent a significant breakthrough in the treatment of NASH and cirrhosis, offering hope to the millions of patients affected by these devastating conditions. Akero Therapeutics plans to continue studying EFX in larger clinical trials to further evaluate its efficacy and safety.
Stay tuned for more updates on this groundbreaking research from Akero Therapeutics and the potential impact of EFX on patients with NASH and cirrhosis.
Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group (p=0.009) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 24% effect size over placebo at 15%
By ITT analysis, with all missing week 96 biopsies treated as failures, 29% of the 50mg EFX group (p=0.031) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 17% effect size over placebo at 12%
Investor webcast at 8:00 am ET Monday, January 27, 2025
SOUTH SAN FRANCISCO, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today released preliminary topline week 96 results from SYMMETRY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH). Among patients with baseline and week 96 biopsies (n=134), 39% of patients treated with 50mg EFX (n=46) (p=0.009) experienced reversal of cirrhosis with no worsening of MASH, compared to 15% for placebo (n=47). In the Intent to Treat (ITT) population (n=181), with all missing week 96 biopsies treated as failures, 29% of patients in the 50mg EFX group (n=63) (p=0.031) experienced reversal of cirrhosis with no worsening of MASH, compared to approximately 12% in the placebo group (n=61).
With more than a doubling of effect size from weeks 36 to 96 in the 50mg group (from 10% to 24%), the SYMMETRY study underscores the benefit of longer EFX treatment for patients with compensated cirrhosis (F4).
In a subgroup of patients with baseline and week 96 biopsies who were not taking GLP-1 at baseline (n=97), 45% in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH (n=29) (p=0.009) compared to 17% for placebo (n=36), suggesting that the observed reversal of cirrhosis was not attributable to GLP-1 therapy.
“Until today, we’ve not had the prospect of an effective treatment for compensated cirrhosis due to MASH, which is associated with high rates of short-term morbidity and mortality,” said Mazen Nourredin, M.D., Professor of Medicine and Transplant Hepatologist at Houston Methodist Hospital, and principal investigator for the SYMMETRY study. “Now we have reason to be optimistic about the future potential of EFX as a much-needed treatment for cirrhosis, if approved. I’m so happy for my patients and patients all around the world.”
Summary of Week 96 Reversal of Cirrhosis Endpoint
Primary Analysis (N=134)1
ITT Analysis (N=181)2
Histology Endpoint3 (Proportion of Patients)
Placebo (N=47)
28mg (N=41)
50mg (N=46)
Placebo (N=61)
28mg (N=57)
50mg (N=63)
≥1 stage fibrosis improvement without worsening MASH (%)
15
29
39 **
12
21
29 *
1 All patients with baseline and week 96 biopsies 2 The 47 randomized and dosed patients who had missing biopsies at week 96 are treated as failures in the ITT analysis (without imputation) 3 Biopsies scored independently by two pathologists; third available to adjudicate (which was not required) * p<0.05, ** p<0.01, versus placebo (Cochran-Mantel-Haenszel test (CMH))
“We believe today’s first-ever public report of reversal of cirrhosis due to MASH, whether by completer or ITT analysis, sets EFX apart from other approved or investigational treatments in the MASH landscape as a compound with transformational potential,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “We look forward to continuing evaluation of 50mg EFX in our ongoing Phase 3 SYNCHRONY Outcomes study in patients with compensated cirrhosis due to MASH.”
The reversal of cirrhosis, as quantified by a consensus of two histopathologists, is supported by improvements in noninvasive measures of liver fibrosis and injury.
Summary of Week 96 Changes in Key Noninvasive Measures of Liver Fibrosis and Injury
Measure
(LS Mean Change From Baseline to Week 96)
Placebo (n=49)
28mg (n=40-41)
50mg (n=47)
ELF Score
+0.22
-0.34 ***
-0.53 ***
Liver Stiffness (%) (FibroScan)
-8
-18
-24 *
ALT (U/L)
-6.8
-10.5
-11.1
AST (U/L)
-1.6
-8.1
-11.2 **
* p<0.05, *** p<0.001, versus placebo (MMRM)
EFX was reported to be generally well-tolerated. There were no deaths on EFX, but one death in the placebo arm due to pneumonia. None of the Serious Adverse Events were determined to be related to study drug. Across both EFX groups, the most frequent adverse events (AEs) were grade 1 or 2, gastrointestinal in origin (diarrhea, nausea, and increased appetite) and transient in nature.
Conference Call / Webcast Details Akero will host a conference call and webcast with slide presentation at 8:00 a.m. ET today. The live webcast will be available on the Events & Presentations page of Akero’s website, with the recording and presentation available immediately following the event.
About Cirrhosis Due to MASH Cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis) is a life-threatening disease with high risk of liver failure, cancer and eventually death. By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, which is the fastest growing cause of liver transplants and liver cancer in the United States and Europe.
About the SYMMETRY Study The Phase 2b SYMMETRY study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH. The study enrolled a total of 182 patients, randomized to receive once-weekly subcutaneous dosing of 28mg or 50mg EFX, or placebo for 36 weeks, 181 of whom received at least one study dose. The primary efficacy endpoint for the study was the proportion of patients who achieve at least one-stage fibrosis improvement without worsening of MASH at week 36. Week 96 secondary measures included ≥1 stage fibrosis improvement and no worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, glycemic control, and lipoproteins, as well as safety and tolerability measures.
About EFX Efruxifermin (EFX), Akero’s lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
About Akero Therapeutics Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero’s lead product candidate, EFX, is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic MASH (F2-F3 fibrosis), SYNCHRONY Outcomes in patients with compensated cirrhosis due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (Metabolic Dysfunction Associated Steatotic Liver Disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and X for more information.
Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero’s business plans and objectives, including future plans or expectations for EFX and ongoing clinical studies, the therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; and the future potential of EFX following the preliminary topline week 96 results of Akero’s Phase 2b SYMMETRY study, which are subject to audit and verification procedures and additional data that could result in material changes in the final data. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include:; the success, cost, and timing of Akero’s product candidate development activities and planned clinical trials; Akero’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in Akero’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero’s other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Akero Therapeutics, a biotechnology company focused on developing innovative treatments for serious metabolic diseases, has announced exciting preliminary topline results from its Phase 2b SYMMETRY study. The study evaluated the efficacy of Akero’s investigational drug in treating compensated cirrhosis (F4) due to metabolic dysfunction-associated fatty liver disease (MAFLD).
The results of the study showed a statistically significant reversal of compensated cirrhosis at Week 96, as demonstrated by both completer and intent-to-treat (ITT) analyses. This is a major milestone in the field of liver disease treatment, as compensated cirrhosis is a severe and irreversible stage of liver damage that can lead to life-threatening complications if left untreated.
“We are thrilled to see such promising results from our Phase 2b SYMMETRY study,” said John M. Taylor, CEO of Akero Therapeutics. “The reversal of compensated cirrhosis in patients with MAFLD is a significant achievement and represents a potential breakthrough in the treatment of this debilitating disease.”
These findings signal a potential new treatment option for patients with MAFLD and offer hope for those suffering from advanced liver disease. Akero Therapeutics plans to continue investigating the efficacy and safety of its drug in larger clinical trials, with the goal of bringing this promising therapy to patients in need.
Stay tuned for more updates on Akero Therapeutics and the progress of its investigational drug in the treatment of MAFLD.
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