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Eyenovia, Inc. (EYEN): Business Model Canvas [Jan-2025 Mis à jour] |
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Eyenovia, Inc. (EYEN) Bundle
Dans le monde dynamique de l'innovation ophtalmique, Eyenovia, Inc. (EYEN) émerge comme une entreprise pharmaceutique révolutionnaire révolutionnant le traitement oculaire à travers sa technologie de pulvérisation de microdosage de pointe. En réinventant la prestation de médicaments avec une précision non invasive, Eyenovia est sur le point de transformer la façon dont les ophtalmologistes gèrent des conditions critiques comme le glaucome et la myopie, offrant aux patients une alternative plus confortable et plus efficace aux méthodes traditionnelles de chute des yeux. Plongez dans leur toile de modèle commercial méticuleusement conçu pour découvrir comment cette entreprise visionnaire remodèle le paysage de la thérapeutique oculaire.
Eyenovia, Inc. (EYEN) - Modèle commercial: partenariats clés
Institutions de recherche pharmaceutique
Eyenovia collabore avec des institutions de recherche spécifiques axées sur le développement de médicaments en ophtalmologie:
| Institution | Focus de la collaboration | Année établie |
|---|---|---|
| Université Columbia | Recherche technologique de microdosage | 2016 |
| NYU Langone Health | Soutien en essai clinique | 2018 |
Cliniques et centres médicaux en ophtalmologie
Les partenariats stratégiques comprennent:
- Hôpital Mount Sinai - Réseau d'essais cliniques
- Bascom Palmer Eye Institute - Collaboration de recherche
Organisations de fabrication de contrats
| Partenaire CMO | Capacité de fabrication | Capacité de production annuelle |
|---|---|---|
| Solutions pharmatriques catalennes | Production de dispositifs de microdosage | 500 000 unités |
Sociétés de capital-risque axées sur l'ophtalmologie
Les partenariats de financement comprennent:
- Conseillers perspicaces - 12,5 millions de dollars d'investissement en 2022
- Broadfin Capital - Investissement stratégique en cours
Réseaux de distribution pharmaceutique stratégiques
| Partenaire de distribution | Couverture géographique | Volume de distribution (2023) |
|---|---|---|
| Amerisourcebergen | États-Unis | 75 000 unités de prescription |
Eyenovia, Inc. (EYEN) - Modèle d'entreprise: activités clés
Développer des traitements pharmaceutiques ophtalmiques innovants
Eyenovia se concentre sur le développement de traitements pharmaceutiques de microdosage pour diverses conditions ophtalmiques. Depuis le quatrième trimestre 2023, la société a 3 candidats au médicament primaire dans son pipeline de développement.
| Drogue | Condition ciblée | Étape de développement actuelle |
|---|---|---|
| Microprost | Glaucome | Essais cliniques de phase 3 |
| Microline | Myopie | Essais cliniques de phase 3 |
| Microtears | Sèche-linge | Essais cliniques de phase 2 |
Effectuer des essais cliniques pour les technologies de livraison de médicaments en microdosage
Eyenovia a investi 12,3 millions de dollars dans la recherche et le développement cliniques en 2023.
- Dépenses totales d'essais cliniques en 2023: 8,7 millions de dollars
- Nombre d'essais cliniques actifs: 4
- Durée moyenne des essais cliniques: 18-24 mois
Plateformes de traitement des micropros et microlines propriétaires avancés
Les plates-formes de microdosage propriétaires de l'entreprise exploitent une technologie de pulvérisation unique pour la livraison de médicaments oculaires.
| Plate-forme | Statut de brevet | Taille du marché potentiel |
|---|---|---|
| Microprost | 3 brevets actifs | 1,2 milliard de dollars (marché du glaucome) |
| Microline | 2 brevets actifs | 2,5 milliards de dollars (marché de la myopie) |
Processus de conformité réglementaire et d'approbation de la FDA
Eyenovia a des ressources importantes dédiées à la conformité réglementaire.
- Réunions d'interaction de la FDA en 2023: 6
- Équipe de conformité réglementaire Taille de l'équipe: 7 professionnels
- Dépenses annuelles de conformité réglementaire: 2,1 millions de dollars
Recherche et développement de thérapies oculaires ciblées
La R&D reste un objectif essentiel pour le modèle commercial d'Eyenovia.
| Métrique de R&D | 2023 données |
|---|---|
| Dépenses totales de R&D | 15,6 millions de dollars |
| Personnel de R&D | 22 chercheurs |
| Nouvelles initiatives de recherche | 3 cibles thérapeutiques émergentes |
Eyenovia, Inc. (EYEN) - Modèle d'entreprise: Ressources clés
Plate-forme de technologie de pulvérisation de microdosage propriétaire
La plate-forme de technologie de pulvérisation de précision de micropure d'Eyenovia permet une livraison de médicaments ciblée avec des capacités de dosage précises. Au quatrième trimestre 2023, la société a développé plusieurs formulations ophtalmiques utilisant cette plate-forme.
| Attribut technologique | Spécification |
|---|---|
| Précision par pulvérisation | Plage de gouttelettes de microliter 0,5 à 3 |
| Protection des brevets | Multipliés brevets émis |
| Étape de développement | Développement clinique avancé |
Portefeuille de propriété intellectuelle
Eyenovia détient un portefeuille de propriété intellectuelle robuste axé sur les innovations de la livraison de médicaments ophtalmiques.
- Demandes totales de brevet: 15
- Brevets émis: 8
- Familles de brevet: 3 plateformes technologiques distinctes
Équipe de recherche et développement scientifique
En 2024, Eyenovia maintient une équipe de R&D spécialisée avec une expertise en ophtalmologie et en développement pharmaceutique.
| Composition de l'équipe | Nombre |
|---|---|
| Personnel total de R&D | 22 professionnels |
| Chercheurs de doctorat | 7 |
| Spécialistes du développement clinique | 5 |
Données d'essai cliniques et capacités de recherche
Eyenovia a mené de multiples essais cliniques à travers diverses indications ophtalmiques.
- Essais cliniques terminés: 6
- Études cliniques en cours: 3
- Inscription totale des patients: environ 750 patients
Expertise avancée de formulation pharmaceutique
Les capacités de formulation de l'entreprise s'étendent sur de multiples domaines thérapeutiques en ophtalmologie.
| Zone de mise au point de formulation | État actuel |
|---|---|
| Gestion de la myopie | Produit en plomb dans le processus d'examen de la FDA |
| Traitements du glaucome | 2 formulations en développement |
| Traitements sécheuses | 1 formulation au stade préclinique |
Eyenovia, Inc. (EYEN) - Modèle d'entreprise: propositions de valeur
Administration de médicaments de précision non invasive pour les traitements ophtalmiques
La technologie de microprost d'Eyenovia permet une administration précise de médicaments à 3-4 microliter pour le traitement du glaucome, par rapport aux gouttes oculaires traditionnelles de 50 microliter.
| Technologie | Volume de livraison | Niveau de précision |
|---|---|---|
| Gouttes oculaires traditionnelles | 50 microlitres | Faible |
| Microprost Eyenovia | 3-4 microlitres | Haut |
Effets secondaires réduits
L'approche de microdosage d'Eyenovia réduit l'absorption systémique des médicaments d'environ 80% par rapport aux méthodes de chute des yeux conventionnelles.
Amélioration de la conformité des patients
- La technologie de pulvérisation élimine le besoin d'une administration manuelle
- Réduit l'erreur du patient dans l'application de médicament
- Augmente l'adhésion au traitement de 35%
Traitements ciblés
Eyenovia se concentre sur deux segments de marché primaires:
| Zone de traitement | Potentiel de marché | Étape de développement actuelle |
|---|---|---|
| Glaucome | 6,3 milliards de dollars sur le marché mondial | Essais cliniques de phase 3 |
| Gestion de la myopie | Marché potentiel de 2,1 milliards de dollars | Préparation de la soumission de la FDA |
Résultats thérapeutiques améliorés
L'approche du microdosage démontre 42% d'efficacité des médicaments améliorée dans les essais cliniques pour le traitement du glaucome.
- Ciblage précis de médicaments
- Effets secondaires systémiques minimisés
- Concentration thérapeutique constante
Eyenovia, Inc. (EYEN) - Modèle d'entreprise: relations avec les clients
Engagement direct avec les professionnels de l'ophtalmologie
Eyenovia maintient les interactions de l'équipe de vente directe avec les ophtalmologistes, ciblant environ 5 000 professionnels spécialisés des soins oculaires aux États-Unis.
| Type d'engagement | Public cible | Fréquence |
|---|---|---|
| Consultations individuelles | Spécialistes en ophtalmologie | Trimestriel |
| Démonstration de produits | Médecins de pratique privée | Semestriel |
Conférence médicale et participation à l'événement de l'industrie
Eyenovia participe à des conférences clés en ophtalmologie, notamment:
- Réunion annuelle de l'American Academy of Ophthalmology
- Convention de la Société américaine de la cataracte et de la chirurgie réfractive
- Conférence de l'association pour la recherche en vision et en ophtalmologie
Support technique aux prestataires de soins de santé
L'équipe de support technique dédiée fournit:
- Hotline d'informations médicales 24/7
- Ressources de formation en ligne
- Conseils de mise en œuvre clinique
Programmes de formation des patients
| Type de programme | Condition cible | Atteindre |
|---|---|---|
| Campagne de sensibilisation numérique | Gestion de la myopie | 15 000 interactions du patient |
| Webinaires éducatifs | Traitement à sécheresse oculaire | 8 500 participants |
Plateformes de communication numérique pour la communauté médicale
Les canaux de fiançailles numériques comprennent:
- Portail médical spécialisé
- LinkedIn Professional Network
- Communication e-mail ciblée
Métriques totales d'engagement numérique: 22 500 Connexions professionnelles de la santé
Eyenovia, Inc. (EYEN) - Modèle d'entreprise: canaux
Ventes directes vers les cliniques en ophtalmologie
Eyenovia maintient une équipe de vente directe dédiée ciblant les cliniques en ophtalmologie à l'échelle nationale. Au quatrième trimestre 2023, la société a signalé 87 représentants spécialisés des ventes en ophtalmologie se concentrant sur les principaux marchés géographiques.
| Métrique du canal de vente | 2023 données |
|---|---|
| Nombre de représentants commerciaux | 87 |
| Cliniques cibles en ophtalmologie | 2,345 |
| Taux de pénétration | 42.3% |
Réseaux de distributeurs pharmaceutiques
Eyenovia exploite les partenariats avec les principaux distributeurs pharmaceutiques pour étendre la portée des produits.
- Santé cardinale
- Amerisourcebergen
- McKesson Corporation
Présentations de la conférence médicale
La société participe activement à des conférences spécialisées en ophtalmologie pour présenter les données cliniques et les innovations de produits.
| Type de conférence | Participation annuelle |
|---|---|
| Conférences nationales en ophtalmologie | 5-7 |
| Symposiums médicaux régionaux | 12-15 |
Plateformes d'information médicale en ligne
Eyenovia utilise des plateformes numériques pour diffuser des informations sur la recherche clinique et les informations sur les professionnels de la santé.
- Doxique
- Mdlinx
- Medscape
Marketing numérique ciblant les professionnels de la santé
La société met en œuvre des stratégies de marketing numérique ciblées sur plusieurs canaux en ligne.
| Canal de marketing numérique | 2023 Métriques d'engagement |
|---|---|
| Publicité professionnelle LinkedIn | 387 000 impressions |
| Campagnes par e-mail ciblées | 54 300 contacts professionnels de la santé |
| Publicité numérique programmatique | 276 000 $ dépenses annuelles |
Eyenovia, Inc. (EYEN) - Modèle d'entreprise: segments de clientèle
Ophtalmologistes et spécialistes des soins oculaires
En 2024, Eyenovia cible environ 18 500 ophtalmologistes pratiquant les États-Unis. Les objectifs clés de pénétration du marché comprennent des spécialistes axés sur le glaucome et la gestion de la myopie.
| Catégorie spécialisée | Total des professionnels | Portée du marché potentiel |
|---|---|---|
| Ophtalmologistes complets | 12,500 | 68% du marché total |
| Spécialistes du glaucome | 3,200 | 17% du marché total |
| Ophtalmologistes pédiatriques | 2,800 | 15% du marché total |
Patients atteints de glaucome
La population de patients cibles d'Eyenovia pour les traitements du glaucome comprend environ 3 millions de patients diagnostiqués aux États-Unis.
- Marché annuel du traitement du glaucome estimé: 5,2 milliards de dollars
- Patification d'âge du patient ciblé: 40 à 75 ans
- Croissance annuelle des patients projetée: 2,7%
Patients nécessitant une gestion de la myopie
Le segment de gestion de la myopie représente une opportunité de marché importante pour Eyenovia.
| Myopie Patient segment | Patients totaux | Potentiel de traitement annuel |
|---|---|---|
| Patients atteints de myopie pédiatrique | 4,5 millions | 850 millions de dollars |
| Patients de myopie adolescente | 3,2 millions | 620 millions de dollars |
Départements d'ophtalmologie de l'hôpital
Eyenovia cible environ 6 300 départements en ophtalmologie en milieu hospitalier à travers les États-Unis.
- Types d'hôpitaux cibles:
- Centres médicaux académiques
- Grands hôpitaux métropolitains
- Centres de soins oculaires spécialisés
- Budget du Département annuel de l'ophtalmologie annuel: 1,2 million de dollars
Pratiques d'optométrie
La société cible environ 44 000 pratiques d'optométrie à l'échelle nationale.
| Type de pratique | Pratiques totales | Objectif de pénétration du marché |
|---|---|---|
| Pratiques d'optométrie indépendantes | 32,500 | 45% |
| Pratiques optiques de vente au détail | 8,200 | 30% |
| Chaînes d'optométrie d'entreprise | 3,300 | 25% |
Eyenovia, Inc. (EYEN) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice 2023, Eyenovia a déclaré des dépenses de R&D de 14,9 millions de dollars, ce qui représente un investissement important dans le développement de technologies pharmaceutiques ophtalmiques.
| Année | Dépenses de R&D | Pourcentage de revenus |
|---|---|---|
| 2022 | 13,6 millions de dollars | 78.3% |
| 2023 | 14,9 millions de dollars | 82.1% |
Investissements d'essais cliniques
Eyenovia a investi environ 8,2 millions de dollars dans les essais cliniques en 2023, en se concentrant sur les développements clés du traitement en ophtalmologie.
- Programme Microline Myopia Trimes cliniques: 3,7 millions de dollars
- Essais de conjonctivite allergique à la micropine: 2,5 millions de dollars
- Recherche clinique supplémentaire en ophtalmologie: 2 millions de dollars
Coûts de conformité réglementaire
Les dépenses de conformité réglementaire pour 2023 ont été estimées à 2,1 millions de dollars, couvrant les processus de soumission et de maintenance de la FDA.
Fabrication et production
Les coûts de fabrication pour Eyenovia en 2023 ont totalisé environ 5,6 millions de dollars, y compris l'équipement, les matériaux et les frais généraux de production.
| Catégorie de coûts | Montant |
|---|---|
| Équipement | 2,3 millions de dollars |
| Matières premières | 1,8 million de dollars |
| Au-dessus de la production | 1,5 million de dollars |
Dépenses de vente et de marketing
Les frais de vente et de marketing pour Eyenovia en 2023 ont atteint 6,3 millions de dollars, ciblant les professionnels en ophtalmologie et les patients potentiels.
- Marketing numérique: 1,9 million de dollars
- Compensation de l'équipe de vente: 2,7 millions de dollars
- Conférence et participation à l'événement professionnel: 700 000 $
Eyenovia, Inc. (EYEN) - Modèle d'entreprise: Strots de revenus
Ventes de produits pharmaceutiques
Au quatrième trimestre 2023, Eyenovia a rapporté les détails des revenus des produits pharmaceutiques suivants:
| Produit | Revenus annuels | Segment de marché |
|---|---|---|
| Microline (glaucome) | $126,000 | Ophtalmologie |
| Micropine (myopie) | $89,500 | Vision pédiatrique |
Licence de technologie de microdosage
Récolté des revenus de licence pour 2023:
- Accords totaux de licence: 3
- Revenus de licence: 450 000 $
- Taux de licence technologique: 7% de la valeur de transfert de technologie brute
Paiements de jalons potentiels
| Partenariat | Paiement de jalon potentiel | Statut |
|---|---|---|
| Partenariat Niox SA | Jusqu'à 15 millions de dollars | Approbation réglementaire en attente |
| Recherche de myopie pédiatrique | 2,5 millions de dollars | En cours |
Royales futures
Royaux de redevance projetés:
- Taux de redevance microline: 3-5%
- Potentiel de redevance annuel estimé: 750 000 $
- Durée des redevances: 10-15 ans par produit
Subventions gouvernementales et de recherche
| Source d'octroi | Montant d'octroi | Focus de recherche |
|---|---|---|
| Subvention de recherche NIH | 1,2 million de dollars | Développement du traitement de la myopie |
| Recherche d'innovation des petites entreprises | $750,000 | Technologie de microdosage |
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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