On the Fast Track to Innovation at OIS@ASRS
Fresh out of Asia, we’ve landed in Chicago to chase down the hottest innovations in retina.
In the race for positive patient outcomes, innovation is paramount – and there’s no better place to track current and upcoming treatments and therapies than at the Ophthalmology Innovation Summit (OIS), where we are now an Official Media Partner. So, the pit crew at PIE Magazine sped across the Pacific and skidded into Chicago (in full race gear, of course) to look under the hood and bring you key insights from some of the top drivers in the industry at OIS@ASRS.
Take me to your leader . . .
Leaders in artificial intelligence (AI), that is. Nah, we’re not talking about science fiction, like robots with feelings, we’re talking about the AI that could revolutionize the way ophthalmologists screen and diagnose patients.
“AI, to me, is a novel advance going forward. Ophthalmology – and retina in particular— is uniquely situated for AI . . . and the impact is going to be huge. We have incredibly large data sets, both curated and not, and our platforms, fundus photography, OCT, etc., are immensely focused on the ability to change the interpretative pattern of the disease,” said Timothy Murray, MD, AI panel moderator and founding director and CEO of Miami Ocular Oncology & Retina (MOOR).
Driving in the AI fast lane was Daruis Moshfeghi, MD, the co-founder of Pr3vent – a company using AI and deep learning to provide vision screening for up to 4 million babies in the U.S. annually. As Dr. Moshfeghi noted, screening that many babies would take a lot of doctors . . . or just one good algorithm. Using AI to save the sight of newborns? Sounds like a champion in our book.
Also in the race is Tracery Ophthalmics – a biomarker-driven, AI-powered, technology stack for precision drug development. The company has three core technologies: TraceryOI (Ophthalmic Imaging technology); TraceryIBB (novel & known Image-Based Biomarkers); and TraceryAI (AI system for Software as a Medical Device or SaMD). President & CEO Shelley Boyd, MD, noted: “In ophthalmology, we rely on images and image-based biomarkers . . . and this is true for some of the biggest healthcare challenges we face. Biomarkers are measures of disease, of health, of treatment efficacy and of safety. They drive clinical decision with the promise of personalized medicine.”
The pit crew from Carl Zeiss Meditec (ZEISS) has their own vision for artificial intelligence, and that to enhance the doctor’s ability to provide care – not to replace doctors. Often doctors are slowed down by data overload, which impacts their ability to support an ever-increasing workload. This results in a higher risk that anomalies go undetected. Therefore, ZEISS is developing an AI-based algorithm to reduce the time the doctor spends scanning through large OCT data cubes by automatically detecting the b-scans of interest.
Niranchana Manivannan, PhD, senior staff scientist, clinical research & analytics development for ZEISS explained: “So, what happens, instead of clinicians going through all 128 b-scans, the feature automatically highlights the scans of interest so clinicians can start from that particular point . . . and that would improve the workflow. Clinicians would have more time to spend with patients and see more patients.”
A pit stop with the crew . . . we may dress outlandishly, but we take innovations in retina very seriously.
Fine-tuning Treatments
Longer-lasting anti-VEGF agents were among the innovations speeding down the pipeline at OIS@ASRS. Below, we get the 411 on some of these proposed treatments . . .
Opthea is working on OPT-302, a novel biologic that binds and neutralizes VEGF-C/-D. According to Megan Baldwin, PhD, CEO & Managing Director, OPT-302 has demonstrated a favorable safety profile in combination with both ranibizumab and aflibercept and there’s evidence of a dose response for OPT-302 combination treatment on gains in BCVA.
AXT107 from AsclepiX Therapeutics is a best-in-class agent that inhibits VEGF and activates Tie2 as a monotherapy. CEO Wendy Perrow says that with AXT107, potentially only one intravitreal injection per year is needed . . . which would dramatically reduce the treatment burden.
Allegro Ophthalmics has two drugs in the pipeline IVT risuteganib and ALG-1007 for topical use in dry eye disease (DED). President & CEO Vicken Karageozian, MD says that risuteganib is being studied in dry AMD and DME – and it met its primary endpoint with statistical significance in U.S. Phase 2 intermediate dry AMD clinical trial. In addition, for ALG-1007, a second, larger Ex-US exploratory Phase 2 study in DED is ongoing with results slated for late 2019.
AMD is characterized by marked mitochondrial defects. As such, Stealth Biotherapeutics’ lead product candidate, elamipretide, stabilizes cristae architecture and electron transport chain structure during oxidative stress by binding to cardiolipin in the inner mitochondrial membrane. CEO Reenie McCarthy says that in ReCLAIM, a 40-patient Phase 1 trial, they found that elamipretide therapy improved regular and lowlight vision in drusen and geographic atrophy cohorts. The drug was well-tolerated and has the potential to improve vision and treat earlier-stage disease – which differentiates elamipretide from other approaches in development.
For Alkahest, Chief Strategy Officer Elizabeth Jeffords discussed an oral solution for treating nAMD: AKST4290. She noted that AKST4290 is safe and well-tolerated and in a recent study, treatment na?ve subjects, 83% of eyes had maintenance or improvement in BCVA with a mean change across all subjects of +7 letters gained; 21% of subjects gained ≥15 letters. She added that “this trial presents early, but intriguing data on the efficacy and safety of AKST4290 as an oral treatment for nAMD.”
Eyedaptic is helping to restore vision using augmented reality (AR) device, which effectively reconstructs the visual field. Founder and CEO Jay Cormier said: “We take in the images through the front-mounted camera and redisplay those in front of the eye. We picked a variety of tasks that included near, intermediate and distance. From a VA standpoint, we saw close to 20 letters gained on average, which I think makes this a good complement device to the drugs out there today and we’re seeing letters gained up to 30.”
In the same AR vein, Ocutrx CEO Michael Freeman presented his company’s device: the Oculenz AR, a wearable visual aid for advanced macular degeneration. “We just did our pre-pilot patient test and it was very successful,” he noted, explaining that all subjects increased functional vision in reading the logMAR eye chart, and paragraphs on the CNEC, as well as in recognizing features of familiar people.
Kodiak Sciences is designing ophthalmic Antibody Biopolymer Conjugates (ABCs) for increased durability and efficacy. Jason Ehrlich, MD, PhD, chief medical officer & chief development officer for Kodiak, highlighted KSI-301, an anti-VEGF ABC that optimizes both molecular weight & formulation strength. He explained that “KSI-301 is an anti-VEGF ABC with encouraging Phase 1a clinical study results. It’s well-tolerated at all dose levels with rapid-onset, high-magnitude responses sustained to 12 weeks.
We’re always interested in hearing from the drivers steering the industry.
Pit Stop with the Industry Leaders
With promising new therapies and treatments, along with innovation propelled by AI, there’s certainly a lot happening in retina. As we speed toward better patient outcomes, some key industry leaders expressed their wish-list for a Triple Crown win.
Chuck Hess, VP, and general manager of US Surgical forBausch + Lomb, says they’re very interested in learning more about these new treatment modalities – and that wet AMD uveitis is of special interest. “We tend to look at it from a device perspective – how do we get these treatments into the eye? A lot of we’ve been doing is trying to partner with other companies to develop devices that can actually facilitate implantation. For us it’s really multi-modality, it’s looking at what’s being done outside, but also leveraging our skill sets internally, to develop new products to aid in the treatment of these patients.”
At Alcon, Ravi Durvasula, PhD, retinal surgical instrumentation R&D, says that in the near term, Alcon is asking: How we can make our systems and instruments more effective? He says that in the longer term, Alcon is developing its next-generation cataract and vitreoretinal platforms. “We also see the need for enhanced visualization . . . one of the things that the surgeons really could benefit from is seeing better and seeing a lot more.”
Christopher Brittain, MRCOphth, MD, MBA, global head of ophthalmology and clinical development for Genentech says one of the largest unmet needs in retina is geographic atrophy: “For me, one of the largest goals we still have is to find a treatment for patients with geographic atrophy. On that side, we do have two ongoing Phase 2 studies. The second is really about prevention . . . I think the AI algorithms and novel targets will help us get to prevention strategy.”
So, there you have it! Certainly, the innovations seen at OIS@ASRS will help steer the future of treatment and patient outcomes in retina . . . so buckle up, it’s going to be a wild ride!