Bausch + Lomb Launches enVista Aspire™ Intermediate Optimized Monofocal and Toric Intraocular Lenses in the European Union
Bausch + Lomb (NYSE/TSX: BLCO) has announced the commercial launch of enVista Aspire monofocal and toric intraocular lenses (IOLs) in the European Union following CE Mark approval. The enVista Aspire combines Intermediate Optimized optics for broader depth of focus with the established enVista platform benefits.
The product features include glistening-free optic material and StableFlex Technology for controlled unfolding. The toric version offers treatment for astigmatism during cataract surgery with a +0.90 cylinder design and AccuSet haptic design for rotational stability.
The IOLs are indicated for primary implantation in adult patients for visual correction of aphakia following cataract lens removal, with the toric version specifically addressing corneal astigmatism. The device uses an optical modification of the posterior aspheric surface to create a small continuous increase in IOL power within the central 1.5 mm diameter.
Bausch + Lomb (NYSE/TSX: BLCO) ha annunciato il lancio commerciale delle lenti intraoculari monofocali e toriche enVista Aspire nell'Unione Europea a seguito dell'approvazione del marchio CE. L'enVista Aspire combina ottiche ottimizzate per l'intermedio per una maggiore profondità di messa a fuoco con i vantaggi già consolidati della piattaforma enVista.
Le caratteristiche del prodotto includono un materiale ottico privo di riflessi e la tecnologia StableFlex per un'apertura controllata. La versione torica offre un trattamento per l'astigmatismo durante l'intervento di cataratta con un design a cilindro +0,90 e un design haptico AccuSet per la stabilità rotazionale.
Le IOL sono indicate per l'impianto primario in pazienti adulti per la correzione visiva dell'afachia a seguito della rimozione del cristallino catarattoso, con la versione torica che affronta specificamente l'astigmatismo corneale. Il dispositivo utilizza una modifica ottica della superficie asferica posteriore per creare un piccolo aumento continuo della potenza della IOL all'interno del diametro centrale di 1,5 mm.
Bausch + Lomb (NYSE/TSX: BLCO) ha anunciado el lanzamiento comercial de las lentes intraoculares monofocales y tóricas enVista Aspire en la Unión Europea tras la aprobación de la marca CE. El enVista Aspire combina ópticas optimizadas para intermedios con una mayor profundidad de enfoque, junto con los beneficios establecidos de la plataforma enVista.
Las características del producto incluyen material óptico sin destellos y tecnología StableFlex para un despliegue controlado. La versión tóricos ofrece tratamiento para el astigmatismo durante la cirugía de cataratas, con un diseño de cilindro de +0.90 y un diseño háptico AccuSet para estabilidad rotacional.
Las IOL están indicadas para la implantación primaria en pacientes adultos para la corrección visual de afacia tras la extracción del cristalino cataratoso, con la versión tóricos dirigida específicamente al astigmatismo corneal. El dispositivo utiliza una modificación óptica de la superficie asférica posterior para crear un pequeño aumento continuo de potencia de la IOL dentro del diámetro central de 1.5 mm.
바우쉬 + 롬 (NYSE/TSX: BLCO)은 CE 마크 승인을 받은 후 유럽 연합에서 엔비스타 아스파이어 단초점 및 토릭 인트라오큘러 렌즈(IOL)의 상업적 출시를 발표했습니다. 엔비스타 아스파이어는 더 넓은 초점 깊이를 위해 중간 최적화된 광학을 결합하여 이미 확립된 엔비스타 플랫폼의 이점을 더합니다.
제품 특징으로는 반짝임 없는 광학 재료와 제어된 펼침을 위한 StableFlex 기술이 포함되어 있습니다. 토릭 버전은 백내장 수술 시 +0.90 실린더 디자인과 회전 안정성을 위한 AccuSet 촉각 디자인으로 난시 치료를 제공합니다.
이 IOL은 백내장 렌즈 제거 후 아파키아의 시각적 교정을 위해 성인 환자에게 주입용으로 사용되며, 토릭 버전은 특히 각막 난시에 대해 다룹니다. 이 장치는 후면 비구면 표면의 광학 수정을 통해 중앙 직경 1.5mm 내에서 IOL의 힘을 지속적으로 소량 증가시키는 방식을 사용합니다.
Bausch + Lomb (NYSE/TSX: BLCO) a annoncé le lancement commercial des lenses intraoculaires monofocaux et toriques enVista Aspire dans l'Union Européenne suite à l'approbation du marquage CE. L'enVista Aspire combine une optique optimisée pour l'intermédiaire offrant une profondeur de champ plus large avec les avantages établis de la plateforme enVista.
Les caractéristiques du produit incluent un matériau optique sans reflets et la technologie StableFlex pour un déploiement contrôlé. La version torique offre un traitement pour l'astigmatisme lors de la chirurgie de la cataracte avec un design de cylindre de +0,90 et un design haptique AccuSet pour la stabilité rotationnelle.
Les IOL sont indiquées pour une implantation primaire chez les patients adultes pour la correction visuelle de l'afachie suite à l'ablation du cristallin cataracté, la version torique s'attaquant spécifiquement à l'astigmatisme cornéen. L'appareil utilise une modification optique de la surface asphérique postérieure pour créer une légère augmentation continue de la puissance de l'IOL dans le diamètre central de 1,5 mm.
Bausch + Lomb (NYSE/TSX: BLCO) hat die kommerzielle Einführung der enVista Aspire monofokalen und torischen intraokularen Linsen (IOLs) in der Europäischen Union nach Erhalt der CE-Kennzeichnung angekündigt. Die enVista Aspire kombiniert zwischenoptimierte Optiken für einen größeren Schärfentiefe mit den etablierten Vorteilen der enVista-Plattform.
Zu den Produkteigenschaften gehören ein glanzfreies optisches Material und die StableFlex-Technologie für kontrolliertes Entfalten. Die torische Version bietet eine Behandlung für Astigmatismus während der Kataraktoperation mit einem +0,90 Zylinderdesign und einem AccuSet-Design zur Gewährleistung der Rotationsstabilität.
Die IOLs sind für die primäre Implantation bei erwachsenen Patienten zur visuellen Korrektur von Aphakie nach der Entfernung der Kataraktlinse vorgesehen, wobei die torische Version speziell auf das hornhautbedingte Astigmatismus abzielt. Das Gerät nutzt eine optische Modifikation der hinteren asphärischen Oberfläche, um innerhalb des zentralen Durchmessers von 1,5 mm eine kontinuierlich kleine Erhöhung der IOL-Leistung zu erzeugen.
- Received CE Mark approval for European market expansion
- Product offers enhanced features including glistening-free optic material
- Toric version provides additional treatment options for astigmatism patients
- Clinical trials have not demonstrated meaningful extension of depth of focus
- Safety and effectiveness of the Aspire IOL optical design not clinically evaluated
Insights
The launch of enVista Aspire IOLs in the EU represents a notable advancement in intraocular lens technology. The platform's Intermediate Optimized optics offers enhanced depth of focus compared to conventional monofocal IOLs, specifically targeting modern digital lifestyle visual needs. The glistening-free optic material and StableFlex Technology address key surgical and post-operative concerns.
The toric variant's ability to treat sub-1 diopter astigmatism with the AccuSet haptic design fills an important market gap. However, the precautions noting lack of clinical evaluation for depth of focus effects, contrast sensitivity and visual disturbances warrant careful patient selection. The EU market expansion could drive meaningful revenue growth, considering the aging population and increasing cataract surgery volumes in the region.
From a market perspective, this EU launch strengthens Bausch + Lomb's competitive position in the $4.5 billion global IOL market. The timing is strategic as Europe faces an aging demographic surge, with cataract surgery rates projected to increase significantly over the next decade. The product's differentiated features targeting digital lifestyle needs align with current market demands and could command premium pricing.
The expansion leverages existing U.S. market experience and established distribution networks, suggesting efficient market penetration potential. While the lack of clinical data on certain performance aspects poses some commercial risk, the proven enVista platform reputation provides a strong foundation for market acceptance.
“Surgeons around the world have long known the benefits of the enVista platform,” said Luc Bonnefoy, president, Surgical, Bausch + Lomb. “In the
Unlike conventional spherical monofocal IOLs and lower-order aspheric IOLs, the enVista Aspire monofocal optics allow for a range of vision beyond one focal point. Like enVista MX60E, enVista Aspire offers a glistening-free optic material and controlled, efficient unfolding through Bausch + Lomb’s proprietary StableFlex™ Technology, which aids optic recovery.
For patients with astigmatism, enVista Aspire Toric IOLs provide a proven option for treatment of their astigmatism during cataract surgery. Featuring a +0.90 cylinder design, the enVista toric IOL platform can treat less than one diopter of astigmatism at the corneal plane. The unique AccuSet haptic design enables exceptional rotational stability, an important attribute for toric lenses.
Indications and Important Safety Information for the enVista Aspire and enVista Aspire toric Hydrophobic Acrylic IOL
Indications: The enVista Aspire™ hydrophobic acrylic IOL (non-preloaded model EA) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia following removal of a cataractous lens.
The enVista Aspire toric IOL is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia and corneal astigmatism following the removal of a cataractous lens for improved uncorrected distance vision.
Device Description: The Aspire IOL uses an optical modification of the posterior aspheric surface to create a small continuous increase in IOL power within the central 1.5 mm diameter to slightly extend the depth of focus. However, clinically meaningful extension of the depth of focus has not been demonstrated in clinical trials.
Warnings
As with any surgical procedure, there is risk involved. Physicians considering IOL implantation under any of the following circumstances should weigh the potential risk/benefit ratio: (1) Recurrent severe anterior or posterior segment inflammation or uveitis; (2) Patients in whom the IOL may affect the ability to observe, diagnose, or treat posterior segment diseases; (3) Surgical difficulties at the time of cataract extraction, which might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss); (4) A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; (5) Circumstances that would result in damage to the endothelium during implantation; (6) Suspected microbial infection; (7) Patients in whom neither the posterior capsule nor zonules are intact enough to provide support.
Precautions
- Neither the safety and effectiveness, nor the effects of the Aspire IOL optical design on depth of focus, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have been evaluated clinically. MTF testing of the Aspire IOL optical design (used in model ETA) may aid the surgeon in understanding the theoretical image quality expected with the Aspire IOL compared to the enVista monofocal IOL MX60E. However, these do not fully assess all aspects of clinical difficulties under all conditions. Surgeons must weigh the potential benefits of the modified optical design of the Aspire IOL (model ETA) against the potential for risks associated with a degradation in vision quality and the lack of clinical data to characterize the impact of the Aspire IOL optical design on contrast sensitivity and subjective visual disturbance. These considerations may be especially relevant to patients with certain pre-existing ocular conditions (prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, optic nerve atrophy, etc.) or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc).
- The safety and effectiveness of the IOL have not been substantiated in patients with pre-existing ocular conditions and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting an IOL in a patient with one or more of these conditions. Physicians considering IOL implantation in such patients should explore the use of alternative methods of aphakic correction and consider IOL implantation only if alternatives are deemed unsatisfactory in meeting the needs of the patient.
- Patients with preoperative problems, such as corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. The physician must determine the benefits to be derived from IOL implantation when such conditions exist.
Adverse Events: As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon transient or persistent glaucoma, and secondary surgical intervention. Secondary surgical interventions include but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair.
ATTENTION: This is not all you need to know. Please refer to the Directions For Use labeling for a complete listing of indications, full risk and safety information, clinical study information, etc.
*Based on optical bench testing. MTF study in IS02 model cornea, comparison of MX60E and enVista Aspire.
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in
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