LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia
LENZ Therapeutics (Nasdaq: LENZ) has submitted a New Drug Application (NDA) to the FDA for LNZ100, an aceclidine-based eye drop designed to improve near vision in people with presbyopia. The submission is supported by positive data from the pivotal Phase 3 CLARITY study, which demonstrated statistically significant improvements in near vision without compromising distance vision.
Key highlights:
- Presbyopia affects an estimated 1.8 billion people globally and 128 million in the US
- LNZ100 achieved all primary and secondary near vision improvement endpoints
- The treatment was well-tolerated with no serious treatment-related adverse events
- The FDA has a 60-day filing review period to determine if the NDA is complete and acceptable for review
LENZ Therapeutics (Nasdaq: LENZ) ha presentato una Richiesta di Nuovo Farmaco (NDA) alla FDA per LNZ100, un collirio a base di aceclidina progettato per migliorare la visione da vicino nelle persone affette da presbiopia. La presentazione è sostenuta da dati positivi provenienti dallo studio pivotale Phase 3 CLARITY, che ha dimostrato miglioramenti statisticamente significativi nella visione da vicino senza compromettere la visione da lontano.
Punti salienti:
- La presbiopia colpisce circa 1,8 miliardi di persone in tutto il mondo e 128 milioni negli Stati Uniti
- LNZ100 ha raggiunto tutti gli endpoint primari e secondari per il miglioramento della visione da vicino
- Il trattamento è stato ben tollerato, senza eventi avversi seri correlati al trattamento
- La FDA ha un periodo di revisione di 60 giorni per determinare se l'NDA è completo e accettabile per la revisione
LENZ Therapeutics (Nasdaq: LENZ) ha presentado una Solicitud de Nuevo Medicamento (NDA) a la FDA para LNZ100, una gota ocular a base de aceclidina diseñada para mejorar la visión cercana en personas con presbicia. La presentación está respaldada por datos positivos del estudio pivotal Phase 3 CLARITY, que demostró mejoras estadísticamente significativas en la visión cercana sin comprometer la visión de lejos.
Aspectos destacados:
- La presbicia afecta a aproximadamente 1.8 mil millones de personas en todo el mundo y a 128 millones en los EE. UU.
- LNZ100 alcanzó todos los puntos finales primarios y secundarios de mejora de la visión cercana
- El tratamiento fue bien tolerado, sin eventos adversos graves relacionados con el tratamiento
- La FDA tiene un periodo de revisión de 60 días para determinar si la NDA es completa y aceptable para su revisión
LENZ Therapeutics (Nasdaq: LENZ)는 LNZ100에 대한 신약 신청서(NDA)를 FDA에 제출했습니다. 이 약물은 노안(presbyopia) 환자의 근거리 시력을 개선하기 위해 설계된 아세클리딘 기반의 눈 방울입니다. 이번 신청은 근거리 시력에서의 통계적으로 유의미한 개선을 보인 주요 Phase 3 CLARITY 연구의 긍정적인 데이터를 기반으로 하고 있습니다.
주요 하이라이트:
- 노안은 전 세계 약 18억 명과 미국에서 1억 2800만 명에게 영향을 미칩니다.
- LNZ100는 근거리 시력 개선을 위한 모든 주요 및 보조 목표를 달성했습니다.
- 치료는 잘 견디며 치료와 관련된 심각한 부작용이 없었습니다.
- FDA는 NDA가 검토를 위한 완전하고 수용 가능한지 여부를 결정하기 위해 60일의 심사 기간을 갖습니다.
LENZ Therapeutics (Nasdaq: LENZ) a soumis une Demande de Nouveau Médicament (NDA) à la FDA pour LNZ100, un collyre à base d'aceclidine conçu pour améliorer la vision de près chez les personnes atteintes de presbytie. La soumission est soutenue par des données positives provenant de l'étude pivot Phase 3 CLARITY, qui a démontré des améliorations statistiquement significatives de la vision de près sans compromettre la vision de loin.
Points clés :
- La presbytie touche environ 1,8 milliard de personnes dans le monde et 128 millions aux États-Unis.
- LNZ100 a atteint tous les points de terminaison primaires et secondaires de l'amélioration de la vision de près.
- Le traitement a été bien toléré, sans événements indésirables graves liés au traitement.
- La FDA dispose d'un délai de révision de 60 jours pour déterminer si la NDA est complète et acceptable pour examen.
LENZ Therapeutics (Nasdaq: LENZ) hat einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) bei der FDA für LNZ100 eingereicht, einen aceclidinbasierten Augentropfen, der entwickelt wurde, um die Nahsicht bei Menschen mit Presbyopie zu verbessern. Der Antrag wird durch positive Daten aus der entscheidenden Phase 3 CLARITY-Studie unterstützt, die statistisch signifikante Verbesserungen der Nahsicht ohne Beeinträchtigung der Fernsicht nachwies.
Wichtige Höhepunkte:
- Presbyopie betrifft schätzungsweise 1,8 Milliarden Menschen weltweit und 128 Millionen in den USA.
- LNZ100 hat alle primären und sekundären Endpunkte zur Verbesserung der Nahsicht erreicht.
- Die Therapie wurde gut vertragen, ohne schwerwiegende behandlungsbedingte unerwünschte Ereignisse.
- Die FDA hat eine Überprüfungsfrist von 60 Tagen, um festzustellen, ob die NDA vollständig und akzeptabel für die Prüfung ist.
- Submission of New Drug Application (NDA) to FDA for LNZ100
- Positive results from Phase 3 CLARITY study supporting NDA submission
- LNZ100 achieved all primary and secondary near vision improvement endpoints
- No serious treatment-related adverse events observed in over 30,000 treatment days
- Potential to be best-in-class pupil-selective and long-acting therapeutic option for presbyopia
- None.
Insights
The NDA submission for LNZ100 marks a significant milestone in the treatment of presbyopia. The positive Phase 3 CLARITY study results demonstrate LNZ100's potential as a best-in-class therapy. Key points:
- Achieved all primary and secondary near vision improvement endpoints
- Statistically significant three-lines or greater improvement in BCDVA at near
- No loss in distance visual acuity
- Well-tolerated with no serious treatment-related adverse events
If approved, LNZ100 could address a vast market of
LENZ Therapeutics' NDA submission for LNZ100 is a pivotal development with significant market implications. Key financial considerations:
- Large addressable market:
1.8 billion people globally,128 million in the US - Potential first-mover advantage: If approved, LNZ100 could capture substantial market share
- Revenue potential: Success could translate to substantial future earnings
- R&D investment validation: Positive Phase 3 results justify development costs
Investors should monitor the 60-day FDA filing review closely. Approval could significantly boost LENZ's stock value, while rejection might lead to a sharp decline. The company's financial health and ability to commercialize LNZ100 effectively will be important factors to watch.
The presbyopia treatment market is poised for disruption with LENZ's LNZ100. Key market insights:
- Unmet need: Current treatments often compromise distance vision or have short duration
- Competitive landscape: LNZ100's pupil-selective, long-acting properties could differentiate it
- Market size:
1.8 billion global,128 million US patients indicate massive potential - Patient preference: Non-invasive eye drop solution likely to be favored over surgical options
If approved, LNZ100 could rapidly gain market share. However, successful commercialization will depend on pricing strategy, reimbursement policies and effective marketing to both healthcare providers and patients. The company's ability to scale production and distribution will be important for capitalizing on this opportunity.
SAN DIEGO, Aug. 12, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that the Company has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic solution) for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States.
“The submission of our NDA for LNZ100 is a significant milestone for LENZ and is a testament to the tremendous focus, execution and collaboration of our team,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “We believe LNZ100 has the potential to be best-in-class as a pupil-selective and long-acting therapeutic option for the treatment of presbyopia. We look forward to working alongside the FDA through this review process.”
The NDA submission is supported by positive data from the pivotal Phase 3 CLARITY study of LNZ100 for the treatment of presbyopia. In the Phase 3 CLARITY study LNZ100 achieved all primary and secondary near vision improvement endpoints with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one line or more in distance visual acuity, demonstrating LNZ100 was well tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days monitored in the CLARITY study.
The FDA has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review.
About LENZ Therapeutics
LENZ Therapeutics is a late clinical-stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve vision in patients with presbyopia. LENZ’s product candidate, LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day.” LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the review and potential approval of our NDA by FDA for the potential regulatory approval and commercialization of LNZ100, if approved; the size of the market opportunity for LNZ100; the beneficial characteristics of LNZ100 and its expected impact on presbyopes; and expectations regarding shareholder value creation. These statements are based on numerous assumptions concerning the development of LENZ’s product candidates and target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in our Form 10-Q filed with the SEC on May 8, 2024, and our subsequent filings with the SEC. We cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Contacts:
Dan Chevallard
LENZ Therapeutics, Inc.
IR@LENZ-Tx.com
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