Eyenovia Provides Update on Phase 3 CHAPERONE Study
Eyenovia (NASDAQ: EYEN) announced that its Phase 3 CHAPERONE study evaluating low-dose atropine in the Optejet platform for pediatric progressive myopia is not meeting its primary endpoint. The independent Data Review Committee found no significant difference in myopia progression between treatment arms (0.01% and 0.1% atropine) and placebo among 252 evaluable patients. The primary endpoint targeted less than 0.5 diopter progression in visual acuity over three years. While safety analysis showed all dosages were well-tolerated, the company plans to terminate the study and is considering strategic options including business combination, reverse merger, or asset sales.
Eyenovia (NASDAQ: EYEN) ha annunciato che il suo studio di Fase 3 CHAPERONE, che valuta l'atropina a basso dosaggio sulla piattaforma Optejet per la miopia progressiva pediatrica, non ha raggiunto il suo obiettivo primario. Il Comitato Indipendente di Revisione dei Dati non ha riscontrato differenze significative nella progressione della miopia tra i gruppi di trattamento (atropina allo 0,01% e 0,1%) e il placebo, su 252 pazienti valutabili. L'obiettivo primario mirava a una progressione della vista di meno di 0,5 diottrie nel corso di tre anni. Sebbene l'analisi di sicurezza abbia mostrato che tutti i dosaggi sono stati ben tollerati, l'azienda prevede di terminare lo studio e sta considerando opzioni strategiche che includono una combinazione aziendale, una fusione inversa o la vendita di attivi.
Eyenovia (NASDAQ: EYEN) anunció que su estudio de Fase 3 CHAPERONE, que evalúa la atropina en baja dosis en la plataforma Optejet para la miopía progresiva pediátrica, no está cumpliendo con su objetivo primario. El Comité Independiente de Revisión de Datos no encontró diferencias significativas en la progresión de la miopía entre los grupos de tratamiento (atropina al 0.01% y 0.1%) y el placebo entre 252 pacientes evaluables. El objetivo primario buscaba menos de 0.5 dioptrías de progresión en la agudeza visual durante tres años. Aunque el análisis de seguridad mostró que todas las dosis fueron bien toleradas, la empresa planea terminar el estudio y está considerando opciones estratégicas que incluyen combinación empresarial, fusión inversa o ventas de activos.
Eyenovia (NASDAQ: EYEN)는 소아 진행성 근시를 위한 Optejet 플랫폼에서 저용량 아트로핀을 평가하는 3상 CHAPERONE 연구가 주요 목표를 충족하지 못했다고 발표했습니다. 독립 데이터 검토 위원회는 252명의 평가 가능한 환자 중에서 치료군(0.01% 및 0.1% 아트로핀)과 플라시보 사이에 근시 진행의 유의미한 차이를 발견하지 못했습니다. 주요 목표는 3년 동안 시력에서 0.5 디옵터 이하의 진행을 목표로 했습니다. 모든 용량이 잘 견딜 수 있음을 보여 준 안전성 분석은 있었습니다. 그러나 회사는 연구를 종료할 계획이며, 사업 결합, 역합병 또는 자산 매각 등을 포함한 전략적 옵션을 고려하고 있습니다.
Eyenovia (NASDAQ: EYEN) a annoncé que son étude de phase 3 CHAPERONE évaluant l'atropine à faible dose sur la plateforme Optejet pour la myopie progressive pédiatrique n'atteint pas son objectif principal. Le Comité de Révision des Données indépendant n'a trouvé aucune différence significative dans la progression de la myopie entre les groupes de traitement (atropine à 0,01 % et 0,1 %) et le placebo parmi 252 patients évaluables. L'objectif principal visait une progression de l'acuité visuelle de moins de 0,5 dioptrie sur trois ans. Bien que l'analyse de sécurité ait montré que tous les dosages étaient bien tolérés, l'entreprise prévoit de terminer l'étude et envisage des options stratégiques telles qu'une combinaison d'entreprises, une fusion inversée ou la vente d'actifs.
Eyenovia (NASDAQ: EYEN) gab bekannt, dass die Phase-3-Studie CHAPERONE zur Bewertung von niedrig dosiertem Atropin auf der Optejet-Plattform für pädiatrische progressive Myopie ihren primären Endpunkt nicht erreicht hat. Das unabhängige Datenbewertungskomitee fand keinen signifikanten Unterschied in der Myopieprogression zwischen den Behandlungsgruppen (0,01 % und 0,1 % Atropin) und dem Placebo unter 252 auswertbaren Patienten. Der primäre Endpunkt zielte auf eine Progression der Sehschärfe von weniger als 0,5 Dioptrien über drei Jahre ab. Obwohl die Sicherheitsanalyse ergab, dass alle Dosierungen gut vertragen wurden, plant das Unternehmen, die Studie zu beenden und erwägt strategische Optionen, darunter Unternehmenszusammenschlüsse, Reverse-Mergers oder den Verkauf von Vermögenswerten.
- All dosages demonstrated good safety profile with mild and infrequent adverse events
- Phase 3 CHAPERONE study failed to meet primary efficacy endpoint
- No significant difference in myopia progression between treatment and placebo groups
- Company forced to terminate the study prematurely
- Strategic alternatives being considered including potential sale or merger
Insights
The failure of the CHAPERONE Phase 3 study represents a significant setback for Eyenovia's pediatric myopia program. The trial's inability to demonstrate efficacy in either treatment arm (0.01% and 0.1% atropine) compared to placebo is particularly concerning, as it undermines the potential commercial viability of their Optejet platform for this indication.
The company's immediate pivot to exploring strategic alternatives, including potential business combinations or asset sales, signals serious concerns about their future direction. With a relatively small market cap of
This is a critical negative development that substantially impacts Eyenovia's investment thesis and future prospects. The failure of CHAPERONE, a key Phase 3 program, will likely result in significant near-term stock pressure and raises questions about the company's cash runway and strategic viability. The mention of exploring "business combination, reverse merger, asset sales" suggests management is considering fundamental corporate restructuring options.
Investors should carefully monitor the company's cash position and burn rate, as pipeline setbacks often lead to increased financing needs at potentially unfavorable terms. The strategic review process typically creates heightened market uncertainty and volatility in share price.
A review of study data by an independent Data Review Committee found that CHAPERONE is not meeting its primary three-year efficacy endpoint
Company to discontinue study, review full data set, and evaluate next steps for the program
NEW YORK, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced that a review of the CHAPERONE data by an independent Data Review Committee (DRC) found that the trial is not meeting its primary endpoint of a less than 0.5 diopter progression in visual acuity over three years. CHAPERONE is Eyenovia’s Phase 3 study evaluating its proprietary drug-device combination of low-dose atropine in the Company’s Optejet dispensing platform as a potential treatment for pediatric progressive myopia.
The DRC reviewed the safety and efficacy data from 252 evaluable patients. The DRC found that the rate of myopia progression was not significantly different between the two active treatment arms (
“We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “We plan to terminate the study, review the data more thoroughly, and evaluate next steps. On behalf of the entire company, I would like to express my sincere appreciation to the children, parents, caregivers and healthcare professionals who participated in this trial, as well as all the Eyenovia team members for their exceptional work on this program.”
In light of the results of this review, the Company is considering a variety of steps to maximize value to all stakeholders, to reduce expenses and to evaluate its strategic options, which may include a business combination, reverse merger, asset sales or a combination of those alternatives. Further information will be made available once the evaluation of strategic options has been completed.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing and commercializing products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is targeted at chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension,
Forward-Looking Statements
Except for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including regulatory submissions, estimated market opportunities for our product candidates and platform technology, the impact of the Gen-2 Optejet device, and the timing for availability and sales growth of our approved products. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.
In addition, such statements could be affected by risks and uncertainties related to, among other things: the availability of sufficient financial resources to make payments on its debt obligations to Avenue Capital and to continue the clinical development and commercialization of our products, as to which no assurance can be given; risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products and product candidates; and our competitive position.
Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.
| Eyenovia Contact: Eyenovia, Inc. Andy Jones Chief Financial Officer ajones@eyenovia.com | Eyenovia Investor Contact: Eric Ribner LifeSci Advisors, LLC eric@lifesciadvisors.com (646) 751-4363 |
FAQ
What were the results of Eyenovia's Phase 3 CHAPERONE study for myopia?
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