What’s up the sleeves of the companies’ that develop tools and therapies? Find out as four innovators reveal what’s in their pipeline for both 2021 and 2022 at the recently held OIS Anterior Innovation Showcase.
Dry eye disease and presbyopia seem to be the focus du jour apart from the competitive advances in lens and equipment technologies for surgical devices — and the heady pace does not look likely to slow down anytime soon if the following innovations are of any indication…
Bausch + Lomb: Lens Implant Intelligence Just Got Smarter
Even with over 150 years of innovation in the healthcare and eye care industry, Bausch + Lomb (New York, USA) is continuing to expand its already comprehensive portfolio of products. This covers the cataract and refractive market (Stellaris Elite and VICTUS); intraocular lenses (Crystalens, enVista and enVista Toric); as well as its whole range of ophthalmic instruments.
In the line-up for 2021, Bausch + Lomb has introduced the eyeTelligence software that enhances the connection for data from pre-surgery assessment to treatment planning and execution, to post-surgery evaluation — all of which helps improve surgeon’s efficacy and accuracy. The software is available exclusively on the Stellaris Elite vision enhancement system.
“With the surgical planning, data transmission and clinical systems analytics, this platform will offer the surgeon, the office and the operating room an increased level of control and insights,” said Chuck Hess, VP and general manager of U.S. Surgical at Bausch+Lomb.
Focusing on Range of Targets
Bringing more value to its Stellaris Elite system, the Vitesse Hypersonic Vitrectomy handpiece uses hypersonic technology to liquefy tissue in a highly-localized zone at the edge of the port. This provides consistent flow encased on a novel-single-lumen design, which can enable more effective vitreous removal.
Next, the SimplifEYE Preloaded Injector for the enVista system helps to ensure proper positioning, thus reducing the risk of lens damage with intuitive operation for procedural efficiency. It is currently only available in the U.S. with 1.25 diopter of cylinder power; this allows for correction down to 0.77 diopters at the corneal plane and provides the opportunity to correct astigmatism during cataract surgery.
Bausch + Lomb has also introduced its latest dispersive ophthalmic viscosurgical device (OVD) ClearVisc™ which features sorbitol as its protective element. Currently, the company has three products in the trial stage, including: a myopia trial using an excimer laser system (their Technolas Teneo range), a trial involving a trifocal version of the enVista IOL, and the new cohesive OVD product.
MGD and Myopia Control
With Novoliq’s NOV03 for dry eye associated with MGD as an asset, Bausch + Lomb’s VP of Medical and Clinical Affairs, Dr. Rob Kissling, said they are excited about fluorinated alkane, which potentially restores normal meibomian gland function while addressing the condition’s pathogenesis.
Further, contact lens wearers might get some relief with the launch of INFUSE/ULTRA daily silicone hydrogel (SIHy) in the U.S. and globally. It has potassium and glycerol in its packaging which reduces hyperosmotic stress and also promotes ocular surface homeostasis.
Bausch + Lomb is getting into medical myopia therapies that reduce pediatric myopia progression in children aged 3-12. Its phase 3 microdose atropine study investigates a delivery system designed for adoption by children and their parents.
Seeing that atropine can complement lens care solutions, they’ve also invested in the Arise™ Orthokeratology System, a cloud-based lens fitting software that streamlines the lens design process and enables eye care professionals to produce highly customizable orthokeratology lenses for myopia patients. Another innovation is the myopia control contact lens, a peripheral defocus model developed by BHVI (Brian Holden Vision Institute).
Allergan: Continuing Durysta’s Impact
After the launch of Durysta in 2020, Allergan is set to unveil a robust pipeline across 5 areas: retinal disease, glaucoma, refractive conditions, dry eye and ocular allergy.
Allergan VP of Global Therapeutic Area and Head of Ophthalmology, Dr. Michael Robinson, focused his presentation on Durysta, a biodegradable bimatoprost intracameral implant (10mcg). He pointed out its efficacy in the Artemis study, which showed IOP was controlled for 80% of patients with no additional treatment at one year after receiving three administrations of the drug. The Duke Eye Center also presented research by Dr. Daniel Stamer that showed how Durysta has a higher concentration of bimatoprost compared to eye drops. It is currently undergoing several clinical trials to allow for multiple re-administrations and approvals outside of the United States.
Eye Drops Adjust “Aperture” for Presbyopia Patients
Speaking of eye drops, excitement over their usage for presbyopia treatment takes center stage again as Allergan (an AbbVie company, Zurich, Switzerland) unveils its ongoing phase 3 investigations in the U.S. on AGN-190584, a once-daily drop which has potentials to improve near vision for a duration of up to 10 hours. It optimizes the pupil size range for presbyopia patients by inducing the iris to create a smaller pupil in order to expand the depth of focus of the eye. This is achieved through equilibrating the pH of the pilocarpine to match the ocular surface. Dr. Robinson said if the FDA approves this, it will be the first medical therapy for the treatment of presbyopia.
Johnson & Johnson’s IOL Pipeline and More
Drawing on its significant legacy of TECNIS® intraocular lenses (IOLs), Johnson & Johnson Vision’s presenting team headed by Senior Director of Global Strategic Marketing, Nancy Sabin, showcased its three new IOLs, all delivered in the new Toric II platform. The first one, TECNIS Eyehance, which was launched in early 2021, is the first monofocal IOL designed to provide a slight increase in depth of focus while delivering better image contrast in low light conditions. Next, the TECNIS Synergy IOL has already been released in international markets (not available in the U.S. as of yet). It has shown superior image contrast at 3 and 5mm pupil sizes, according to Senior Director of Global IOL R&D at Johnson & Johnson Vision, Patricia Piers.
Frosted, Square Haptic Designed IOLs
Next, Ms. Piers highlighted an important development: the TECNIS Toric II 1-Piece IOL with a new frosted and square haptic design that provides added friction in the capsular bag. This, she said, can reduce positive, edge-related dysphotopsia. “The TECNIS Toric II remains the same as its Toric I predecessor which corrects the spherical aberration of the eye on average, to zero. TECNIS Eyehance and Synergy will also have this toric design and will continue to carry the advantages of the TECNIS platform into the next generation of our innovations,” she said.
New Durometer Tubing System
Surgeons might welcome the innovation in fluidics management and ergonomics with Johnson & Johnson Vision’s Veritas Vision System. It features a dual durometer tubing system in the new pack. “It’s hard on the inside and soft on the outside,” said the Head of Surgical Vision R&D at Johnson & Johnson Vision, Dr. M.K. Raheja. “This allows easier handling of the system, while the softer inside allows better chamber control,” he explained. The system also features a new gas-forced infusion (GFI) feature and an updated venting algorithm.
Ergonomically, the industry’s first VERITAS Swivel handpiece has also been introduced, he said. The design will help surgeons handle the nucleus without tubing getting in the way. Not only that, there will be a remote control for the system and a modernized GUI (graphical user interface) with new color scheme and navigation.
Catalyst for Advances
For 2022, Johnson & Johnson Vision has set their sights on Catalys Launched earlier, the Catalys Innovation (6.0) astigmatism management system will utilize AI to improve pre-op and post-op outcomes. Apart from that, they’re working on the femtosecond laser lenticule refractive surgery which promises speedier surgeries. “We’re researching the phaco cadence NextGen system to really look into whole fluidics, post-occlusion surgery and chamber stability in a completely different sort of way to do it better,” Dr. Raheja said, adding they’re also looking at the next generation PC-IOL (posterior chamber intraocular lenses), newer IOL materials, lens platforms and improving its LipiFLow system.
Novartis: Dry Eye Rescue and Beyond
The company has just produced Xiidra® in the United States. “It’s an extraordinary revolution in the care of dry eye,” said Aileen Wrynn, program head of ocular surface disease at Novartis. “It’s the only Rx approved to treat both signs and symptoms of dry eye disease (DED). It relieves symptoms as early as two weeks after treatment initiation and has a very unique MOA, a first-in-class novel mechanism of action locking key drivers of inflammation in dry eye disease,” she shared.
However, Ms. Wrynn said dry eye is more than an irritation. “It is a vision disease. If left untreated in some patients, it may lead to permanent vision impairment. Increased screen use and even mask use in the time of COVID has contributed to an increase in dry eyes,” she said.
Enter ECF843, Novartis’ next generation multi-modal biologic to treat DED. It is a recombinant human form of endogenously expressed lubricin, a natural mucin-like glycoprotein present on the ocular surface in tears. It has anti-inflammatory, lubricating and anti-adhesive properties. In clinical data, it has shown to quickly improve signs and provide relief with excellent patient tolerability and safety.
Another area of innovation for Novartis is SAF213, a potential first-in-indication therapy for chronic ocular surface pain (COSP). This condition can result from recurrent corneal erosion, ocular surgery, mechanical injury and dry eye. The highly specific TRPV1 antagonist is undergoing its phase 2 trial.
Drops of Nearer Vision Hope
Seeing the niche in having no approved drug targeting the underlying causes of presbyopia, Novartis is attempting to fill the gap with UNR844, a topical ophthalmic. Mark Wuttke, global program head of refractive shared how the ester of lipoic acid and choline penetrates the cornea and is thought to reduce the disulfide bonds that may contribute to lens stiffness. Initial phase studies showed treatment with UNR844 improved near vision after 3 months with sustained results for 7 months. Novartis has also developed an app to help patients to track their vision; this helps patients to know when to contact their eye care providers to access their near vision to determine if they need another round of treatment, or another method of near vision correction.
Diligent, Digital Fun for Lazy Eyes
Mr. Wuttke also covered another exciting treatment on the horizon for children. Amblyopia, or “lazy eye” reduces visual acuity in the affected eye and patients tend to have poor 3D vision. The standard of care is to wear an eye patch, Wuttke said, adding that patching does not always result in good outcomes. “Besides the risk of recurrence within the first year of patching, it also spurs improvement in monocular vision of the affected eye; it may not improve 3D vision which depends on binocular vision.” Patching is also less effective in older children and for adults, there is no effective treatment.
In 2020, Novartis acquired a company that developed a game utilizing binocular dichoptic therapy that allows patients to treat their amblyopia in as little as 8 weeks. Subjects would play a game where some elements of the game were presented to one eye and some elements to the other.
The interactive “active therapy” has potential to modify underlying amblyopia disorder and restore stereopsis; it is currently undergoing investigation for adults and children without the need for patching. There are prospective potentials also for “passive therapy” involving movies and videos with this game.
“This year, we’re commencing a proof-of-concept study in children 4 to 7-years-old, followed by pivotal studies in both children and adults,” said Mr. Wuttke.
“In addition, Novartis is also developing novel digital tools to measure both stereopsis and to measure the progress of amblyopic patients to potentially guide and improve their therapy,” he said.
According to Mr. Wuttke, Novartis is collaborating with Dr. Robert Hess of McGill University who pioneered dichoptic therapy and Ubisoft, an international gaming company to develop this unique therapy.
Editor’s Note: The OIS Anterior Innovation Showcase: Corporate Pipeline Presentations was held on April 8, 2021. Reporting for this story took place during the event.
