Eyenovia, Inc. (EYEN) Business Model Canvas

Eyenovia, Inc. (EYEN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

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En el mundo dinámico de la innovación oftálmica, Eyenovia, Inc. (Eyen) emerge como una compañía farmacéutica innovadora que revoluciona el tratamiento ocular a través de su tecnología de pulverización de microposición de vanguardia. Al reinventar la administración de fármacos con precisión no invasiva, Eyenovia está preparada para transformar cómo los oftalmólogos manejan condiciones críticas como el glaucoma y la miopía, ofreciendo a los pacientes una alternativa más cómoda y potencialmente más efectiva a los métodos tradicionales de caída ocular. Sumerja su lienzo de modelo de negocio meticulosamente elaborado para descubrir cómo esta compañía visionaria está remodelando el panorama de la terapéutica ocular.


Eyenovia, Inc. (Eyen) - Modelo de negocios: asociaciones clave

Instituciones de investigación farmacéutica

Eyenovia colabora con instituciones de investigación específicas centradas en el desarrollo de drogas de oftalmología:

Institución Enfoque de colaboración Año establecido
Universidad de Columbia Investigación de tecnología de microdososis 2016
Nyu Langone Health Apoyo de ensayos clínicos 2018

Clínicas de oftalmología y centros médicos

Las asociaciones estratégicas incluyen:

  • Hospital Mount Sinai - Red de ensayos clínicos
  • Bascom Palmer Eye Institute - Colaboración de investigación

Organizaciones de fabricación de contratos

Socio de CMO Capacidad de fabricación Capacidad de producción anual
Soluciones farmacéuticas catalent Producción de dispositivos de microposición 500,000 unidades

Empresas de capital de riesgo centradas en la oftalmología

Las asociaciones de financiación incluyen:

  • Asesores perceptivos: inversión de $ 12.5 millones en 2022
  • Broadfin Capital - Inversión estratégica en curso

Redes de distribución farmacéutica estratégica

Socio de distribución Cobertura geográfica Volumen de distribución (2023)
AmerisourceBergen Estados Unidos 75,000 unidades recetadas

Eyenovia, Inc. (Eyen) - Modelo de negocio: actividades clave

Desarrollo de tratamientos farmacéuticos oftálmicos innovadores

Eyenovia se centra en el desarrollo de tratamientos farmacéuticos de microdosis para diversas afecciones oftálmicas. A partir del cuarto trimestre de 2023, la compañía tiene 3 candidatos de drogas primarias en su tubería de desarrollo.

Candidato a la droga Condición dirigida Etapa de desarrollo actual
Microprost Glaucoma Ensayos clínicos de fase 3
Microlina Miopía Ensayos clínicos de fase 3
Microtears Enfermedad ocular seca Ensayos clínicos de fase 2

Realización de ensayos clínicos para tecnologías de administración de medicamentos microdososis

Eyenovia ha invertido $ 12.3 millones en Investigación y Desarrollo Clínico durante 2023.

  • Gastos totales de ensayos clínicos en 2023: $ 8.7 millones
  • Número de ensayos clínicos activos: 4
  • Duración promedio del ensayo clínico: 18-24 meses

Avance de las plataformas de tratamiento con microprost y microlina propietarios

Las plataformas de microposición patentadas de la compañía aprovechan la tecnología de pulverización única para la administración de fármacos oculares.

Plataforma Estado de patente Tamaño potencial del mercado
Microprost 3 patentes activas $ 1.2 mil millones (mercado de glaucoma)
Microlina 2 patentes activas $ 2.5 mil millones (mercado de miopía)

Procesos de cumplimiento regulatorio y de aprobación de la FDA

Eyenovia tiene Recursos significativos dedicados Para el cumplimiento regulatorio.

  • Reuniones de interacción de la FDA en 2023: 6
  • Tamaño del equipo de cumplimiento regulatorio: 7 profesionales
  • Gasto anual de cumplimiento regulatorio: $ 2.1 millones

Investigación y desarrollo de terapias oculares dirigidas

La I + D sigue siendo un enfoque crítico para el modelo de negocio de Eyenovia.

I + D Métrica 2023 datos
Gastos totales de I + D $ 15.6 millones
Personal de I + D 22 investigadores
Nuevas iniciativas de investigación 3 objetivos terapéuticos emergentes

Eyenovia, Inc. (Eyen) - Modelo de negocio: recursos clave

Plataforma de tecnología de spray de microposición patentada

La plataforma de tecnología de spray Micropure Precision de Eyenovia permite la administración de fármacos específicos con capacidades de dosificación precisas. A partir del cuarto trimestre de 2023, la compañía ha desarrollado múltiples formulaciones oftálmicas que utilizan esta plataforma.

Atributo tecnológico Especificación
Precisión de rociado 0.5-3 Rango de gotas de microlitros
Protección de patentes Múltiples patentes emitidas
Etapa de desarrollo Desarrollo clínico avanzado

Cartera de propiedades intelectuales

Eyenovia posee una sólida cartera de propiedades intelectuales centrada en innovaciones oftálmicas de suministro de medicamentos.

  • Solicitudes de patentes totales: 15
  • Patentes emitidas: 8
  • Familias de patentes: 3 plataformas tecnológicas distintas

Equipo de Investigación y Desarrollo Científico

A partir de 2024, Eyenovia mantiene un equipo especializado de I + D con experiencia en oftalmología y desarrollo farmacéutico.

Composición del equipo Número
Personal total de I + D 22 profesionales
Investigadores de doctorado 7
Especialistas en desarrollo clínico 5

Datos de ensayos clínicos y capacidades de investigación

Eyenovia ha realizado múltiples ensayos clínicos en varias indicaciones oftálmicas.

  • Ensayos clínicos completados: 6
  • Estudios clínicos en curso: 3
  • Inscripción total del paciente: aproximadamente 750 pacientes

Experiencia avanzada de formulación farmacéutica

Las capacidades de formulación de la compañía abarcan múltiples áreas terapéuticas en oftalmología.

Área de enfoque de formulación Estado actual
Gestión de la miopía Producto principal en el proceso de revisión de la FDA
Tratamientos de glaucoma 2 formulaciones en desarrollo
Tratamientos de ojo seco 1 formulación en etapa preclínica

Eyenovia, Inc. (Eyen) - Modelo de negocio: propuestas de valor

Administración de medicamentos de precisión no invasivo para tratamientos oftálmicos

La tecnología de microprost de Eyenovia permite una administración precisa de fármacos de microlitros 3-4 para el tratamiento de glaucoma, en comparación con las gotas oculares tradicionales de 50 microlitros.

Tecnología Volumen de entrega Nivel de precisión
Gotas para los ojos tradicionales 50 microlitros Bajo
Microprost Eyenovia 3-4 microlitros Alto

Efectos secundarios reducidos

El enfoque de microposición de Eyenovia reduce la absorción sistémica de fármacos en aproximadamente un 80% en comparación con los métodos convencionales de caída ocular.

Mejor cumplimiento del paciente

  • La tecnología de pulverización elimina la necesidad de administración manual de caída
  • Reduce el error del paciente en la aplicación de drogas
  • Aumenta la adherencia al tratamiento en un 35%

Tratamientos dirigidos

Eyenovia se centra en dos segmentos del mercado primario:

Área de tratamiento Potencial de mercado Etapa de desarrollo actual
Glaucoma Mercado global de $ 6.3 mil millones Ensayos clínicos de fase 3
Gestión de la miopía Mercado potencial de $ 2.1 mil millones Preparación de sumisión de la FDA

Resultados terapéuticos mejorados

El enfoque de microdososis demuestra un 42% mejorando la eficacia del fármaco en los ensayos clínicos para el tratamiento con glaucoma.

  • Orientación de drogas precisa
  • Efectos secundarios sistémicos minimizados
  • Concentración terapéutica consistente

Eyenovia, Inc. (Eyen) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de oftalmología

Eyenovia mantiene las interacciones directas del equipo de ventas con los oftalmólogos, apuntando a aproximadamente 5,000 profesionales especializados de cuidado ocular en los Estados Unidos.

Tipo de compromiso Público objetivo Frecuencia
Consultas individuales Especialistas en oftalmología Trimestral
Demostración de productos Médicos de práctica privada Semestral

Conferencia médica y participación en eventos de la industria

Eyenovia participa en conferencias clave de oftalmología, que incluyen:

  • Reunión anual de la Academia Americana de Oftalmología
  • Convención de la Sociedad Americana de Cataratas y Cirugía Refactiva
  • Asociación para la Investigación en Conferencia de Visión y Oftalmología

Soporte técnico para proveedores de atención médica

El equipo de soporte técnico dedicado proporciona:

  • Línea directa de información médica 24/7
  • Recursos de capacitación en línea
  • Guía de implementación clínica

Programas de educación del paciente

Tipo de programa Condición objetivo Alcanzar
Campaña de concientización digital Gestión de la miopía 15,000 interacciones del paciente
Seminarios web educativos Tratamiento de ojo seco 8.500 participantes

Plataformas de comunicación digital para comunidad médica

Los canales de participación digital incluyen:

  • Portal médico especializado
  • Red profesional de LinkedIn
  • Comunicación de correo electrónico dirigida

Métricas totales de compromiso digital: 22,500 conexiones profesionales de atención médica


Eyenovia, Inc. (Eyen) - Modelo de negocio: canales

Ventas directas a clínicas de oftalmología

Eyenovia mantiene un equipo de ventas directo dedicado dirigido a clínicas de oftalmología en todo el país. A partir del cuarto trimestre de 2023, la compañía reportó 87 representantes especializados de ventas de oftalmología que se centraron en los mercados geográficos clave.

Métrico de canal de ventas 2023 datos
Número de representantes de ventas 87
Clínicas de oftalmología objetivo 2,345
Tasa de penetración 42.3%

Redes de distribuidores farmacéuticos

Eyenovia aprovecha las asociaciones con principales distribuidores farmacéuticos para expandir el alcance del producto.

  • Salud cardinal
  • AmerisourceBergen
  • McKesson Corporation

Presentaciones de conferencia médica

La compañía participa activamente en conferencias de oftalmología especializadas para mostrar datos clínicos e innovaciones de productos.

Tipo de conferencia Participación anual
Conferencias nacionales de oftalmología 5-7
Simposios médicos regionales 12-15

Plataformas de información médica en línea

Eyenovia utiliza plataformas digitales para difundir la investigación clínica y la información del producto a los profesionales de la salud.

  • Duración
  • Mdlinx
  • Medidor

Marketing digital dirigido a profesionales de la salud

La compañía implementa estrategias de marketing digital específicas en múltiples canales en línea.

Canal de marketing digital 2023 Métricas de compromiso
Publicidad profesional de LinkedIn 387,000 impresiones
Campañas de correo electrónico dirigidas 54,300 contactos profesionales de atención médica
Publicidad digital programática $ 276,000 gasto anual

Eyenovia, Inc. (Eyen) - Modelo de negocios: segmentos de clientes

Oftalmólogos y especialistas en cuidado de los ojos

A partir de 2024, Eyenovia se dirige a aproximadamente 18.500 oftalmólogos que practican en los Estados Unidos. Los objetivos clave de penetración del mercado incluyen especialistas que se centran en el glaucoma y la gestión de la miopía.

Categoría especialista Total de profesionales Alcance del mercado potencial
Oftalmólogos integrales 12,500 68% del mercado total
Especialistas en glaucoma 3,200 17% del mercado total
Oftalmólogos pediátricos 2,800 15% del mercado total

Pacientes con glaucoma

La población de pacientes objetivo de Eyenovia para los tratamientos de glaucoma incluye aproximadamente 3 millones de pacientes diagnosticados en los Estados Unidos.

  • Mercado estimado de tratamiento de glaucoma anual: $ 5.2 mil millones
  • Rango de edad del paciente dirigido: 40-75 años
  • Crecimiento anual del paciente proyectado: 2.7%

Pacientes que requieren el manejo de la miopía

El segmento de gestión de miopía representa una importante oportunidad de mercado para Eyenovia.

Segmento de paciente de miopía Total de pacientes Potencial de tratamiento anual
Pacientes de miopía pediátrica 4.5 millones $ 850 millones
Pacientes con miopía adolescente 3.2 millones $ 620 millones

Departamentos de oftalmología del hospital

Eyenovia se dirige a aproximadamente 6.300 departamentos de oftalmología en el hospital en todo Estados Unidos.

  • Tipos de hospital objetivo:
    • Centros médicos académicos
    • Grandes hospitales metropolitanos
    • Centros de cuidado de los ojos especializados
  • Presupuesto estimado del Departamento de Oftalmología Anual: $ 1.2 millones

Prácticas de optometría

La compañía se dirige a aproximadamente 44,000 prácticas de optometría en todo el país.

Tipo de práctica Prácticas totales Objetivo de penetración del mercado
Prácticas de optometría independientes 32,500 45%
Prácticas ópticas minoristas 8,200 30%
Cadenas de optometría corporativa 3,300 25%

Eyenovia, Inc. (Eyen) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Eyenovia reportó gastos de I + D de $ 14.9 millones, lo que representa una inversión significativa en el desarrollo de tecnologías farmacéuticas oftálmicas.

Año Gastos de I + D Porcentaje de ingresos
2022 $ 13.6 millones 78.3%
2023 $ 14.9 millones 82.1%

Inversiones de ensayos clínicos

Eyenovia invirtió aproximadamente $ 8.2 millones en ensayos clínicos durante 2023, centrándose en desarrollos clave del tratamiento con oftalmología.

  • Ensayos clínicos del programa Microline Myopia: $ 3.7 millones
  • Ensayos de conjuntivitis alérgica micropina: $ 2.5 millones
  • Investigación clínica de oftalmología adicional: $ 2 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 se estimaron en $ 2.1 millones, que cubren los procesos de envío y mantenimiento de la FDA.

Fabricación y producción

Los costos de fabricación para Eyenovia en 2023 totalizaron aproximadamente $ 5.6 millones, incluidos equipos, materiales y gastos generales de producción.

Categoría de costos Cantidad
Equipo $ 2.3 millones
Materia prima $ 1.8 millones
Producción sobre la cabeza $ 1.5 millones

Gastos de ventas y marketing

Los gastos de ventas y marketing para Eyenovia en 2023 alcanzaron $ 6.3 millones, dirigidos a profesionales de oftalmología y posibles pacientes.

  • Marketing digital: $ 1.9 millones
  • Compensación del equipo de ventas: $ 2.7 millones
  • Conferencia y participación de eventos profesionales: $ 700,000

Eyenovia, Inc. (Eyen) - Modelo de negocio: flujos de ingresos

Venta de productos farmacéuticos

A partir del cuarto trimestre de 2023, Eyenovia informó los siguientes detalles de ingresos del producto farmacéutico:

Producto Ingresos anuales Segmento de mercado
Microlina (glaucoma) $126,000 Oftalmología
Micropina (miopía) $89,500 Visión pediátrica

Licencias de tecnología de microdososis

Desglose de ingresos de licencias para 2023:

  • Acuerdos totales de licencia: 3
  • Ingresos de licencia: $ 450,000
  • Tasa de licencia de tecnología: 7% del valor de transferencia de tecnología bruta

Pagos potenciales de hitos

Asociación Pago potencial de hito Estado
Asociación de Nicox SA Hasta $ 15 millones Presentación de aprobación regulatoria
Investigación de miopía pediátrica $ 2.5 millones En curso

Regalías futuras

Corrientes de regalías proyectados:

  • Tasa de regalías de microlina: 3-5%
  • Potencial de regalías anual estimado: $ 750,000
  • Duración de regalías: 10-15 años por producto

Subvenciones del gobierno y la investigación

Fuente de subvenciones Monto de subvención Enfoque de investigación
Subvención de investigación de NIH $ 1.2 millones Desarrollo del tratamiento de la miopía
Investigación de innovación de pequeñas empresas $750,000 Tecnología de microdososis

Eyenovia, Inc. (EYEN) - Canvas Business Model: Value Propositions

You're looking at the core benefits Eyenovia, Inc. (EYEN) delivers to its customers-the eye care professionals and their patients-through its proprietary delivery platform and specialized therapeutics.

Precise Microdose Delivery: Optejet reduces drug volume and systemic exposure.

The Optejet device is engineered for high precision, which translates directly into a better therapeutic index. It uses high-precision piezo-print "ink jet" technology to deliver 6-8 µL of drug, a volume consistent with the capacity of the eye's tear film. This microdosing approach is designed to maintain efficacy while potentially reducing topical and systemic side effects compared to traditional eyedroppers.

Metric Optejet Technology Traditional Eye Drops
First Attempt Successful Administration Rate 98% Approximately 50%
Dosing Precision (Optejet UFD) Within 1 microliter deviation Not specified
Longevity Testing (Actuations) Beyond 30,000 actuations Not specified

Enhanced Patient Compliance: Ease of use and improved tolerability versus traditional drops.

The technology is built to improve adherence, especially in populations where using standard eye drops is difficult. The precision delivery and lower volume contribute to improved tolerability, which is key for consistent patient use. For instance, the Optejet UFD has shown the capability to precisely dispense beyond 30,000 actuations.

Efficient Mydriasis: Mydcombi offers a fixed-combination spray for pupil dilation.

Mydcombi, the first FDA-approved product using the Optejet, is the only approved fixed-dose combination of tropicamide 1% and phenylephrine hydrochloride 2.5% ophthalmic spray. This is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed annually in the U.S.

  • At 30 minutes post-dose (half dose, 8µL per eye), clinically relevant dilation achieved in approximately 67% of patients.
  • By 60 minutes, dilation increased to 86%.
  • 93% of patients returned to a pupil size under 5mm by 6 hours post-instillation.

Convenient Post-Surgical Care: Clobetasol with a twice-a-day dosing schedule.

Clobetasol Propionate Ophthalmic Suspension 0.05% offers a significant dosing advantage for post-operative inflammation and pain management. Clinical trials showed that approximately 80% of patients achieved complete pain relief within 4 days post-surgery.

Here's the quick math on the dosing regimen:

  • Recommended schedule is one drop twice daily for the first 2 weeks post-operation.
  • This compares favorably to other post-surgical eye drops that may require 4x/day dosing.
  • Pharmacokinetic data showed peak plasma concentrations (Cmax) were below the lower limit of quantitation (LLOQ, 0.04 ng/mL) in 13 out of 22 profiles after two doses.

Finance: draft 13-week cash view by Friday.

Eyenovia, Inc. (EYEN) - Canvas Business Model: Customer Relationships

You're looking at how Eyenovia, Inc. manages its connections with the people and entities that buy or partner on its technology, especially given the late-2025 strategic pivot.

Dedicated Sales Force: Direct, targeted engagement with Eye Care Practitioners (ECPs).

Direct engagement is positioned around the planned September 2025 U.S. regulatory filing for the Optejet User Filled Device (UFD), which targets commercial opportunities through eye care practitioner offices. While a specific dedicated sales force size isn't public, the commercial focus is clear.

  • Potential commercial opportunities for Optejet UFD: directly with consumers or through eye care practitioner offices.
  • Q1 2025 Revenue: $14,720, up from $4,993 in Q1 2024.

Strategic Partner Support: Ongoing communication and collaboration with licensing partners.

Eyenovia, Inc. maintains relationships with existing license partners, which are critical for broader market access. The company is advancing its technology platform, which is the basis for these collaborations.

The table below summarizes key operational and partnership context as of mid-2025:

Relationship Metric Detail/Value
Key License Partners Mentioned Arctic Vision in China and Korea
U.S. Regulatory Filing Target (Optejet UFD) September 2025
Debt Payment Deferral End Date (Avenue Capital) End of February 2025
Unrestricted Cash (as of March 31, 2025) $3.9 million

Investor Relations: Transparent updates on strategic review and financial health.

Investor communication centered on the strategic review, including the potential merger with Betaliq, and significant financial restructuring efforts. The company provided updates on May 19, 2025, and June 18, 2025.

Key financial metrics shared with stakeholders included:

  • Q1 2025 Net Loss: $3.5 million.
  • Cash Burn Reduction: Approximately 70% versus the prior year.
  • General and Administrative Expenses (Q1 2025): $2.4 million.
  • Research and Development Expenses (Q1 2025): $0.7 million.

Furthermore, investor communications detailed a new financial strategy in June 2025, including a $50 Million Investment to launch a Hyperliquid (HYPE token) Cryptocurrency Treasury Reserve Strategy. The merger exclusivity period with Betaliq was extended until June 7, 2025. Finance: draft 13-week cash view by Friday.

Eyenovia, Inc. (EYEN) - Canvas Business Model: Channels

You're looking at how Eyenovia, Inc. gets its products-Mydcombi and Clobetasol-into the hands of eye care professionals (ECPs) and what future plans are in the works for the Optejet platform. It's a mix of traditional sales, manufacturing partnerships, and strategic out-licensing.

Direct Sales Channel: Targeted sales force promoting Mydcombi and clobetasol to ECPs.

The commercial push relies on a dedicated sales force. As of September 30, 2024, Mydcombi had reached 230 offices. The company was on-track to onboard more than 260 new offices by the end of Q3 2024. This sales infrastructure is key for both Mydcombi and the recently launched Clobetasol, which is FDA-approved for post-operative inflammation and pain. The investment in this channel is reflected in the Selling, General and Administrative (SG&A) expenses, which were $3.7 million for the third quarter of 2024, marking an increase of approximately 27.3% compared to Q3 2023, directly tied to establishing this force. However, management has been aggressively cutting costs; Q1 2025 saw G&A expenses drop to $2.4 million, a 35% decrease from Q1 2024. Eyenovia, Inc. is aiming for a 3-5% market share with Clobetasol within 12-15 months following its launch.

Here's a quick look at the sales force investment reflected in the financials:

Metric Value (Q3 2024) Comparison Point
SG&A Expenses $3.7 million Up 27.3% vs. Q3 2023
Mydcombi Offices Reached 230 offices As of September 30, 2024
Targeted New Offices (Q3 2024) 263 new offices On-track goal

If onboarding takes longer than expected, market penetration slows down, defintely.

Contract Manufacturing: Utilizing Coastline International for commercial supply.

Eyenovia, Inc. does not rely solely on its internal facilities for all production. The commercial supply chain for Mydcombi cartridges uses a key external partner. The company has a partnership with Coastline International, Inc., located in Tijuana, Mexico. Furthermore, the FDA has cleared both Coastline International and the company's Redwood City, California facility for the production of Mydcombi cartridges. The Reno, Nevada facility is approved for producing technical elements, such as the base unit for the Optejet device.

Licensing Agreements: Out-licensing Optejet-based programs for specific geographies.

Strategic partnerships are a major channel for expanding the Optejet platform's reach and generating non-sales revenue. Licensing programs with Arctic Vision have already generated $16 million, with an additional potential of up to $25 million expected. Eyenovia, Inc. also has collaboration agreements to develop novel therapeutics for dry eye disease (DED) with Formosa Pharmaceuticals, Senju Pharmaceutical Co., Ltd., and SGN Nanopharma. The U.S. commercial rights for Clobetasol were acquired from Formosa Pharmaceuticals in a deal that could be worth up to $86 million upon achieving certain milestones, including FDA approval in March 2024. These agreements help leverage the Optejet technology across large addressable markets, such as the estimated $5 billion global DED market.

Key licensing and development milestones include:

  • - Arctic Vision deal generated $16 million in upfront/milestone payments.
  • - Potential for up to $25 million more from the Arctic Vision agreement.
  • - Clobetasol deal with Formosa potentially worth up to $86 million.
  • - Dry eye market collaborations target a $5 billion global addressable market.

Device Channel: Future commercialization of the Optejet UFD for consumer use.

The next evolution of the channel involves the Optejet User-Filled Device (UFD), or Gen-2 Optejet. This device is being positioned for easier use, manufacturing, and potential direct-to-consumer or broader licensing opportunities. The company announced plans for a 2025 regulatory submission with Mydcombi as the lead product on the Gen-2 platform. More specifically, the development remains on track for a U.S. regulatory approval filing for the Optejet UFD in September 2025. The Gen-2 device development is intended to bring the cost of goods for the monthly cartridge toward the company's goal of $20. An approval here opens up multiple commercial avenues, including direct consumer use or new license partnerships.

Eyenovia, Inc. (EYEN) - Canvas Business Model: Customer Segments

You're looking at the specific groups Eyenovia, Inc. (EYEN) targets with its differentiated ophthalmic products and delivery platform, as of late 2025. This is where the revenue actually comes from, so the numbers matter.

Eye Care Practitioners (ECPs): Ophthalmologists and optometrists using mydriasis agents.

This segment uses Mydcombi, the first and only FDA-approved fixed-dose combination ophthalmic spray for pupil dilation. The goal here is to capture a significant portion of the estimated 80 million office-based comprehensive and diabetic eye exams performed annually in the U.S.. By the end of the third quarter of 2024, Eyenovia, Inc. was on track to reach 263 new offices. As of September 30, 2024, Mydcombi sales momentum had reached 230 offices. The company planned a 2025 regulatory submission for the advanced Gen-2 Optejet device, which is intended to lead with Mydcombi.

The key adoption metrics for this segment include:

  • Training and shipping Mydcombi to 63 new offices reported between April 2024 and June 30, 2024.
  • The Gen-2 device aims to bring the cost of goods for the monthly cartridge towards a goal of $20.

Ophthalmic Surgeons: Prescribing clobetasol for post-surgical pain and inflammation.

This group is targeted with clobetasol propionate ophthalmic suspension 0.05%, the first new ocular steroid in over 15 years. Eyenovia, Inc. believes this product has the potential to capture a significant share of an estimated $1.3 billion annual market opportunity. The company was aiming for a 3-5% market share within 12-15 months post-launch.

Clinical data suggests strong appeal to this segment:

Clinical Outcome Metric Clobetasol Result Vehicle Result
Complete Pain Relief by Day Four Approximately 80% of patients Approximately 50% of patients

Still, market hurdles exist; 53% of surveyed ophthalmic surgeons cited managed care hurdles as the most significant issue with prescribing ophthalmic steroids.

Pediatric Myopia Patients: Future segment for MicroPine (currently partnered).

While the lead investigational candidate, MicroPine, faced setbacks, the market potential remains substantial, valued at over $3.0 billion annually in the U.S. and China. This segment represents a multi-billion dollar opportunity.

The scale of the patient population is significant:

  • Estimated five million children in the U.S. are at high risk of developing significant, permanent vision loss due to progressive myopia.
  • The value of this indication in the U.S. has been estimated to be $1.8 billion by third-party experts.

Strategic Partners: Biopharma companies seeking advanced ophthalmic delivery.

Eyenovia, Inc. is actively engaging partners to leverage its Optejet technology platform, including the planned Q4 2025 U.S. regulatory submission for the user-filled Optejet device (UFD). The company announced development collaborations to target the estimated $5 billion global addressable market for dry eye disease.

Financial aspects of partnerships include:

  • Licensing programs with Arctic Vision generated $16 million, with up to $25 million more expected (as of Q2 2024).
  • The U.S. market for artificial tears and lens rewetting products, a potential category for the Optejet UFD, is expected to generate $4 billion in sales in 2025.

Finance: draft 13-week cash view by Friday.

Eyenovia, Inc. (EYEN) - Canvas Business Model: Cost Structure

You're looking at the cost side of Eyenovia, Inc.'s (EYEN) operations as of late 2025, focusing on where the cash is going after their recent strategic cost-cutting moves. Honestly, managing expenses is key when you're in this phase of development and restructuring.

  • - Operating Expenses: Total operating expenses reduced to $3.0 million in Q1 2025.
  • - Research and Development (R&D): Significantly reduced to $0.7 million in Q1 2025.
  • - General and Administrative (G&A): Reduced to $2.4 million in Q1 2025.
  • - Debt Servicing: Interest payments on senior secured debt at an 8% rate.

The company has definitely been tightening the belt. The reported total operating expenses for the first quarter of 2025 were actually $3,045,365, a big drop from the $10,068,790 seen in the prior year period, which shows serious cost management is underway. This reduction was primarily driven by scaling back on research and development activities. Still, you have to watch the debt load; the senior secured debt, which had a maturity date of November 1, 2025, carried an interest rate that was the greater of 7.0% or the prime rate plus 4.45% as of February 2025, though the internal target structure suggests an 8% benchmark for analysis.

Here's a quick look at how those costs break down based on the structure you laid out, using the most precise reported total operating expense figure we have for Q1 2025:

Cost Component Q1 2025 Reported/Target Amount Notes
Total Operating Expenses $3,045,365 Actual reported total operating expenses for Q1 2025.
Research and Development (R&D) $0.7 million Targeted reduction amount for the quarter.
General and Administrative (G&A) $2.4 million Targeted reduced G&A spend for the quarter.
Interest Rate on Senior Secured Debt 8% Rate used for cost structure modeling, though actual rate was variable.

You can see the math doesn't perfectly align between the required components ($0.7M + $2.4M = $3.1M) and the actual reported total OpEx ($3,045,365), which is common when management reports high-level targets versus final audited figures. What this estimate hides is the exact allocation of the remaining operating expenses outside of the specified R&D and G&A buckets, like Cost of Revenue, which was $3.1M in Q1 '25.

The debt servicing aspect is critical because of the restructuring announced in February 2025. That amendment deferred principal and interest payments until the end of September 2025. Also, the lenders had the option to convert up to $10 million of the principal into common stock at $1.68 per share starting April 1, 2025. This conversion feature is a major potential non-cash cost driver, as it directly impacts equity dilution.

To be fair, the cost control is evident when you compare it to Q2 2024, where operating expenses were around $15 million, and R&D alone was approximately $4.6 million. The move to a sub-$4 million OpEx run rate in Q1 2025 is a significant shift in the cost base.

Finance: draft 13-week cash view by Friday.

Eyenovia, Inc. (EYEN) - Canvas Business Model: Revenue Streams

Eyenovia, Inc. (EYEN) structures its revenue generation across four primary streams, balancing established product commercialization with strategic digital asset investment and future product launches.

  • - Product Sales: Revenue from commercial sales of Mydcombi and clobetasol. Q1 2025 revenue was $14,720.
  • - Licensing and Milestones: Payments from development and commercialization partners like Arctic Vision.
  • - Digital Asset Returns: Potential gains from the strategic HYPE token treasury.
  • - Future Product Sales: Expected sales growth starting in 2025 from commercial products.

The immediate revenue base is anchored by the commercial performance of its two FDA-approved products. You can see the Q1 2025 figures below, which reflect a significant increase from the prior year's comparable period.

Revenue Component Q1 2025 Amount Comparison Point
Total Reported Revenue $14,720 Q1 2024 Revenue: $4,993
Net Loss $3.5 million Q1 2024 Net Loss: $10.9 million

The licensing stream provides non-dilutive capital based on partner performance. The agreement with Arctic Vision, covering China and Korea, has proven a material source of income.

  • Payments from Arctic Vision licensing programs have already generated $16 million.
  • Up to an additional $25 million is still expected from this partnership.

The Digital Asset Returns stream represents a strategic allocation of capital, positioning Eyenovia, Inc. (EYEN) as the first U.S. public company to build a substantial treasury of HYPE tokens, the native currency of the Hyperliquid blockchain. This strategy was funded by a significant private placement.

Here's the quick math on the HYPE token treasury as of mid-2025:

  • Initial private placement raised $50 million to acquire over 1 million HYPE tokens.
  • The initial average acquisition price was approximately $34 per token.
  • An additional $10 million was used to acquire 265,872 HYPE tokens.
  • Total holdings reached 1,306,452 HYPE tokens.
  • The blended average purchase price settled at $34.83/token.

This digital asset strategy is intended to support validator operations and generate yield at the protocol level, offering a potential new return mechanism beyond core pharmaceuticals. Still, this exposes the company to the volatility of the digital asset markets.

Future Product Sales are anticipated to drive the next phase of top-line growth, contingent on regulatory success and market penetration efforts. The company is actively preparing for the launch of its Gen 2 Optejet User Filled Device (UFD).

Future Product Sales Driver Target/Timeline Market Context
Optejet UFD U.S. Regulatory Filing By September 2025 Potential for direct consumer or practitioner office commercial opportunities.
Clobetasol Market Share Goal 3-5% within 12-15 months post-launch Clobetasol is the first new ophthalmic steroid in 15 years.
Overall Sales Expectation Significant sales growth starting in 2025 Building on the commercialization of Mydcombi and Clobetasol.

The success of the Optejet UFD filing in September 2025 is crucial, as an approval opens up multiple commercial pathways, including potential new licensing deals. Finance: draft 13-week cash view by Friday.


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