A Weltanschauung (World View) of OIS for…the World
For the first time, Asia-Pacific's ophthalmic industry along with Europe’s and the United States’, has access to key discussions from the Ophthalmology Innovation Summit (OIS)…immediately.
Just today, the OIS@AAO happened in Chicago, and we are bringing you insights not tomorrow or later this month…but today. It happened today and you have it today, with PIE Today. That’s right, “Today”: two great syllables with nearly all the immediacy of Now.
So, freshly over my Vietnam-to-USA jetlag, let’s get crackalackin'...
Highlights from “Masters of the Industry” at OIS
“I still want to know why the three of you can’t sit back on your couch,” wondered James Mazzo, Global President for Ophthalmology, Carl Zeiss Meditec AG – in what was perhaps the most important question of the day.
A number of the “Masters of the Industry” were lunging forward on their couch, while others were slouched.
While the mystery was never revealed, they did share some key insights. But if you prefer to go straight to the innovation, skip the Masters, and scroll toward the bottom.
'Masters of the Industry' session
David Endicott, CEO – Alcon: There’s a lot of need to be spending time on myopia - particularly the rate at which it is growing in Asia. It’s a lot about handheld devices. How we slow myopia or reverse it or see the opportunities to treat it [is critical]. We are really excited about refractive surgery. We are interested in prevention. We are really focused on retina. It is a very exciting time for development in the retina space. It’s also an important one where we will develop in the myopia space.
Tom Frinzi, Worldwide President, Surgical - Johnson & Johnson Vision: Industry does have today and certainly tomorrow has to have a global mindset. We launched Symfony outside the US in 2013. We all share a collective responsibility in terms of thinking globally particularly around unmet needs. Myopia is exploding not only in Asia-Pacific but around the world.
William Meury, Chief Commercial Officer – Allergan: The partnership between industry and eye care specialists is a 10 [out of 10]. It’s better than in other areas of medicine. Ophthalmologists have greater appreciation for innovation and are more receptive to innovating new products. They know how to work with industry in ways others do not. It is a great space to be in, and a lot easier than in other ones.
Ludwin Monz, PhD, President & CEO – Carl Zeiss Meditec AG: Artificial intelligence will be able to make a better diagnosis. The doctor will more become a data scientist. The doctor will use computer systems and not so much do analysis of data himself. It also will free up time for the physician. Automation will be very fast. The growing workload will eat that up. The biggest change I see is in the diagnostic field. Treatment planning will be better and automized very much. I do not believe digital technology will have a direct impact on surgery. The surgeon will still be in control.
David W. Parke, II, MD, CEO – American Academy of Ophthalmology (AAO): We are starting to note some things that are counterintuitive. We looked at the rate of endophthalmitis. We were told it goes up as you get older. That’s wrong. But it does go up in young adults. That leads to an investigation to get better outcomes. Typical ophthalmologists are being pressured from peers to payers to demonstrate outcomes. This is going to be an even more robust process in the future - and it’s all for the good.
Calvin Roberts, MD, SVP, Chief Medical Officer – Bausch + Lomb: I think doctors will sit in front of a computer and look at data monitors. You will need to check this data because this patient at home has gotten three readings not in the norm. The digital revolution will involve monitoring patients, generating data on them, and making decisions based on information generated on patients other than at the [doctor] office.
Steve Speares, Executive Director – American Society of Cataract & Refractive Surgery (ASCRS): Having spent part of my life in the back of the eye, one of the things remarkable to me is AMD patient advocacy groups. In other parts of ophthalmology, we don’t have strong patient advocacy groups, particularly in the area of glaucoma. Also, even in areas that may not seem related, we have to recognize there cannot be enough education and information as technologies are launched. 23% [of membership] are doing intravitreal injections at ASCRS.
The "Mozarts" from PIE Magazine.
Dry Eye: As important as AMD
In other news, the staff of PIE Magazine broke into the OIS Breakout Session on the “Evolution of the Dry Eye Market.” Our media passes were not valid there, but our Mozart costumes were, and allowed us to sit among ophthalmology’s finest dry eye thinkers and observe.
Of course, we took everything with a grain of retina salt.
“Is dry eye disease different from AMD or glaucoma?” saidChristian Roesky, M.D., Ph.D., NOVALIQ. “Well, it impacts vision. That’s driving attention from investors and hope for patients.”
In other words, dry eye is just an important a disease as AMD, the panelists seemed to agree.
“In 2010, a room like this would have been populated with 4-5 people,” said Quinton Oswald, CEO, Notal Vision, who spoke to a packed meeting room. “The world has changed significantly.”
Caroline Blackie, OD, PhD, Medical Director, Ocular Surface Disease - Johnson & Johnson Vision, agreed. “In 2005 when TearScience was founded, we had a limited understanding of the health of the ocular surface and Meibomian gland dysfunction; that is unrecognizable when you think of that today. Dry eye today is a massive, overwhelming, huge patient population. It is shifting from a highly reactive space to a proactive approach. It determines whether patients can wear the contact lenses they want, or whether they can select the refractive or cataract surgery they want.”
Prey Gupta, MD, Clinical Medical Director, Duke University Eye Center, added: “I joined the faculty at Duke almost 10 years ago and nobody wanted to do dry eye. We just started to realize the visual impact dry eye has. With cataract surgery and refractive surgery, the ocular surface is very much tied to success with dry eye technologies. The potential impact dry eye has on a vast patient population is amazing.”
Even liberal Mozart is freaked out by all the ophthalmic revolutions at OIS.
Enough Yakety-Yak: Let’s Talk Technology
Continuing our PIE Magazine Issue 07 Cover Story theme, “If Mozart were instead an ophthalmologist today, what revolutionary tools and therapies would he use?” we…of course came to OIS dressed as Mozart (in fact 2 Mozarts – conservative and liberal Mozart – in the spirit of America’s great political divide) …and did continue to find revolutions.
Here are some of them:
Allegro’s lead investigational drug, Risuteganib (Luminate) is a broad-spectrum anti-integrin peptide likely to start phase 3 DME clinical trials in the first half of 2019. It is said to inhibit all four oxidative stress-induced pathways in DME. It “has the potential ability to treat the anti-VEGF inadequate responders,” said Vicken Karageozian, M.D., President & CEO, Allegro. “We have shown it can go toe-to-toe with anti-VEGF.”
Meanwhile, “We will really try to answer the question – can 6 month dosing be achieved with an intravitreal approach?” said Charles Semba, M.D., Chief Medical Officer, Graybug Vision. Graybug is focusing on an extended dosing duration in wet AMD, reducing the treatment burden for patients and physicians. The technology involves a bioabsorbable microparticle delivery to enable sustained drug delivery up to 12 months.
By the way, typing here at midnight and eating 7-11 sweet Sriracha style grilled chicken breast skewers – that’s the Asian in me that can’t leave Asia or its jetlag back home … and I just got Sriracha in my eye. Ahhh – where’s an ophthalmologist when you need one?!?! Retina subspecialty day is still hours away!!!
Hemera Biosciences is working on gene therapy called HMR59 targeting dry AMD (which is in Phase 1), wet AMD (also in phase 1), and diabetic eye disease (Phase 1-ready), said CEO Adam Rogers.
CEO Clark E. Tedford presents LumiThera updates at OIS.
LumiThera, alternatively, is focused completely on dry AMD – using a novel form of Photobiomodulation (PBM), successfully used in various therapeutic areas of the body currently. Already they have compelling clinical and pathological results from 3 clinical studies, and the drug is CE Mark approved in Europe. Specifically, the Valeda Light Delivery System is the first approved treatment for dry AMD using PBM. In one study (LIGHTSITE), 50% of PBM patients got a 5+ letter benefit in terms of a VA letter score. Statistically significant reductions in drusen volume also were seen at 1 year. The company established a distribution partnership with Optos for 12 EU and Scandinavian countries, said Clark E. Tedford, PhD, Co-founder, President & CEO.
CEO Rich Small presents on Neurotech at OIS.
An exciting new therapy for MacTel is on the horizon. Renexus by Neurotech releases ciliary neurotrophic factor (CNTF), which is a neuroprotective agent demonstrated to slow photoreceptor cell death. The MacTel study is currently in Phase 3. A separate indication for Renexus to treat glaucoma is in Phase 2. There is no current treatment for MacTel.
Exciting indeed…Eine kleine Nachtmusik kind of exciting, which I could use right now paired with my Red Bull to get me through the writing night. Note to readers: It’s still daytime in Asia-Pacific, so PIE Today is no misnomer!
Eyedaptic has put an innovative twist on low vision aids. The company simulates natural vision with its US FDA Class I Exempt Device. The company’s solution is effective for the full field of vision, wearable for mobility, and employs AR for seamless integration.They use open market AR hardware and proprietary software to provide sufferers with AMD, for example, simulated natural vision.
AMPPLIFY particles penetrate through tear film mucines to optimize drug delivery to target eye tissues, according to Mark Iwicki, Chairman and CEO. It’s by Kala Pharmaceuticals.
'Evolution of the Dry Eye Market' panel.
Back to dry eye, the TearCare System by Sight Sciences is being spearheaded to provide localized heat instead of warm compresses. MGD, dry eye or blepharitis are all target indications. It includes a natural-blink design, ultra-precise Meibomian gland clearance, and features a first-of-its-kind smart system, said Chief Commercial Officer Shawn O’Neil.
Invensys Technology is a novel drug delivery platform that “turns the eye into a biofactory,” said Patricia Zilliox, CEO and President. What a cool word: biofactory! This involves the direct provision of plasmids into the ciliary muscle, using electrotransfection. The ciliary muscle cells then become a production site for therapeutic proteins encoded by plasmids, Ms. Zilliox said. The protein is secreted into the choiroid, vitreous and aqueous humor, reaching the back of the eye. The plasmid candidates are supposed to enable sustained therapeutic protein expression in the eye. The product is being explored for retinitis pigmentosa, non-infectious uveitis, dry AMD, wet AMD, DME, RVO and glaucoma.
iSTAR Medical is exploring the next generation MIGS device, which is made of anti-fibrotic medical grade silicone STAR material. The lead product is the MINIject, easy to implant in the supra-ciliary space, anti-fibrotic, soft, conforming to eye shape, safe, significant and sustained performance, and low post-operative pain management, said CEO Michael Vanbrabant. Positive 1-year data was presented for the first time at OIS. “The safety profile continues to look very promising,” said Mr. Vanbrabant. “ECD side effects are not expected due to material properties and proper placement in the anterior chamber. Performance data supports utility and patient acceptance being excellent for the vast majority of mild to moderate glaucoma patients.”
PowerVision Co-Founder Barry Cheskin made the case for his IOLs. “There is a strong and rapidly growing body of clinical evidence,” he said. FluidVision monocular and binocular implants are undergoing single center and multi center studies – with South Africa and Europe having implanted over 150 eyes. FluidVision 20/20 binocular implants, for example, are undergoing multi-center international studies – specifically randomized/controlled studies vs. monofocals (ORION study) and vs. trifocals (CLEAR study). More than 100 eyes have been studied in such a manner.
Omega Ophthalmics is advancing the idea of the 3D capsule, with the Gemini Refractive Capsule. This allows “no fibrosis around the lens position, fills the 3D space of a natural lens, and there are no issues with position of the lens. Capsule volume stays intact, allowing for future lens implantations. They call it “The Optical Real Estate Platform.” They are positioning it as a “disruptive change” but also a “new standard lens for cataract surgery,” according to the company's website. At its core, it provides a protective environment to house intraoperative technology in the eye.