Seen and Heard at the American Academy of Ophthalmology Annual Meeting

Update on Topcon-IBM Watson Health Collaboration

Selected to participate in IBM’s Watson Health medical imaging collaborative, Topcon has divulged few specifics, but at the AAO Technology Pavilion two key players in the initiative – Steve Tolle of IBM Watson Health and Lloyd Hildebrand, MD, FACS, CEO and chief medical officer of Inoveon Corp., the ifa systems AG subsidiary that’s structuring the collaboration on Topcon’s behalf – talked about the logistics and potential of cognitive computing in ophthalmology. Topcon last year acquired 50.1% of ifa systems, one of the leading IT providers for eye care.

The idea is to bring information stored in tens of millions of patient records to the physician at the point of patient contact, Tolle said. “What if I could present to you, as you treat a patient, data on thousands of patients with the same exact condition?” Tolle asked. “Not from graphics, but based on the same exact lesion, the same exact disease. What would you do with that information?”

Bringing the power of cognitive computing to ophthalmology via Watson involves three steps, Tolle said: “training” Watson to recognize the eye and its physiology and pathology, segmenting and classifying the data so it’s retrievable, and creating a platform to build on the knowledge base to aid in decision making. This involves Watson digesting massive amounts of data. “We’ve run 10 million images already through Watson, so Watson can now automatically detect what organ it’s looking at, and in some cases what condition the organ is in,” Tolle said.

“Voracious” is how Dr. Hildebrand described Watson’s appetite for data. “It can read 50 million documents in about 15 seconds,” he said “That means it can read the entire annual ophthalmic literature in less than a second.” IBM has not revealed a schedule for the Watson eye health initiative.

Valeant CEO Lays Out Strategy for Bausch + Lomb

Valeant CEO Joe Papa, who joined the company last spring after his predecessor J. Michael Pearson vacated the corner suite, met the ophthalmic media at a reception hosted by Bausch + Lomb. Papa talked about how eye care is one of Valeant’s four pillars – along with dermatology, gastrointestinal, and consumer products – and discussed trends that show eye care is well positioned for growth, most notably because people over age 60 utilize eye care at almost eight times the rate of their juniors, according to data from the Organisation for Economic Co-ordination and Development.

Papa also affirmed the company will follow the advice of the Patient Access and Pricing Committee, which he appointed when he took the job, and hold drug price increases to the single digits for the foreseeable future. “And we would not take an average price increase of more than what the historical rates were,” Papa added.

In the meantime, Valeant is still looking to “go after” innovation, in Papa’s words, despite its debt. He outlined three approaches to this: internal development, licensed technology, and business development and acquisition. At its booth in the AAO exhibit hall, B+L put on display a result of that strategy – the new Stellaris Elite phacovitrectomy platform. This evolved device incorporates features from the VersaVIT from Synergetics, which B+L acquired last year, further improved by the internal development team. B+L plans to launch Stellaris Elite in 2017.

Iridex Micropulse Therapy Draws Crowds

There was a steady flow of traffic in the AAO exhibit hall booth of Mountain View, CA-based Iridex, whose tissue-sparing micropulse glaucoma therapy has been gaining traction. It is performed using the Cyclo G6 system, which includes a dedicated laser along with a family of single-use probes. Since the introduction of the system in early 2015, Iridex has shipped approximately 400 lasers worldwide.

Several presentations at the Iridex booth addressed the need for new approaches to treat glaucoma, with current treatment options typically lacking either safety or efficacy. All surgeons noted that this technology offers an “ideal solution” for chronic disease management for several reasons, including that it is easy to learn, is efficient and repeatable, and leaves future treatment options open.

Rolando Toyos, MD, of Memphis, TN, gave one of the more interesting talks, titled “CycloG6 – An Alternative to Stents for Glaucoma.” Dr. Toyos discussed his excellent results with the Cyclo G6, noting that patients have experienced a 30% to 45% reduction in intraocular pressure (IOP) and a 50% to 60% decrease in the need for glaucoma drops.

He said that his region has a shortage of glaucoma specialists. Coupled with very poor medication compliance, he acknowledged, “We have been losing the war against vision loss.” Dr. Toyos strongly endorsed the Iridex laser, and tells his patients that this is a “more gentle, softer” treatment option.  He also positions this approach as an alternative to performing a minimally invasive glaucoma surgery (MIGS) procedure.

Affirmative Trial Results Accompany CyPass Launch

But MIGS did get a boost at AAO when Alcon launched the CyPass Micro-Stent for the US. This coincided with the release of data from two clinical trials reported at AAO: COMPASS, the largest study of MIGS to date, and the CYCLE study.

In reporting on COMPASS, Tsontcho Ianchulev, MD, presented 12-month results that showed intraocular pressure (IOP) reductions of 25.5% in cataract surgery patients who had phacoemulsification only and 31.7% in those who had phaco with CyPass implantation. In the CyPass group, 89% were on no medication for glaucoma a year later versus 52.3% in controls.

Steven Vold, MD, also reported on single-center, three-year results that showed 61% of patients who received the CyPass had IOP lower than 18 mm Hg without medication, and they were on an average of 0.3 medications at 36 months versus 1.5 at baseline for those who had phaco only. “Supraciliary microstent implantation combined with cataract surgery demonstrated safe and effective outcomes versus cataract surgery alone through 36 months,” Dr. Vold concluded.

AGTC Files IND for Second Gene Therapy for Achromatopsia

Applied Genetic Technologies Corp., otherwise known as AGTC, left AAO with big plans. A day after the meeting ended, AGTC filed an Investigational New Drug application (IND) with the FDA to conduct a Phase I/II clinical trial of its gene therapy candidate for the treatment of achromatopsia caused by mutations in the CNGA3 gene. AGTC already has a Phase I/II clinical trial of its gene therapy platform for achromatopsia caused by mutations in the CNGB3 gene in the works.

Achromatopsia, an inherited retinal disease characterized by visual acuity and extreme light sensitivity, results from mutations in one of several genes. About 75% of people with the disease have mutations in the CNGA3 or CNGB3 genes, the two genes AGTC’s platform are targeting. Approximately 10,000 people in the US and 17,000 people in Europe have achromatopsia.

Said AGTC president and CEO Sue Washer: “We believe this filing validates the flexibility and broad utility of our adeno-associated virus-based gene therapy platform to develop multiple gene-based therapies for rare, inherited ophthalmic diseases and this program will be the fourth ophthalmic gene therapy candidate we have advanced to human trials.”

Lucentis Prefilled Syringe Gets FDA Approval

With the availability of a Lucentis (ranibizumab) biosimilar in India and another in the US in a Phase I/II trial, Genentech has taken a step that may preserve its franchise as biosimilar competitors emerge: The company announced during AAO that the FDA had approved a Lucentis 0.5 mg prefilled syringe for treatment of age-related macular degeneration (AMD) and macular edema after retinal vein occlusion.

Other biopharma companies have taken similar steps to preserve their franchises as biosimilar agents advance through the pipeline. For example, last year Amgen launched Neulasta Onpro, an on-body system for injecting pegfilgrastim in patients the day after they’ve received chemotherapy.

The prefilled syringe, or PFS, contains Lucentis 0.5 mg. The idea is to eliminate several steps in the injection process, Genentech stated in a press release – disinfecting the vial, attaching a filter needle, using the needle to draw medicine from the vial, removing the filter needle from the syringe, and replacing it with an injection needle. With Lucentis PFS, physicians attach the injection needle to the syringe and adjust the dose prior to administration.

Envisia Releases Favorable Phase II Data of Glaucoma Agent

Another news item that broke during AAO was Envisia Therapeutics’ release of an interim analysis of Phase II data for its glaucoma agent ENV515 (travoprost XR). The results showed a 26% decline in intraocular pressure (IOP) from baseline over a nine-month period, comparable to existing agents.

The ongoing Phase II trial is a 12-month safety and efficacy evaluation that enrolled five glaucoma patients in the US. The pre-washout baseline for all patients in this cohort, treated pre-study with latanoprost (Xalatan, Pfizer) and bimatoprost (Lumigan, Allergan), was 19.7 mmHg, with a post-washout baseline of 26.1 mmHg for 8 a.m. IOP.

A single low dose of ENV515 decreased the mean 8 a.m. IOP by 6.7 ± 3.8 mmHg, or 26%, over nine months (mean of all 8 a.m. IOPs over nine months). The mean 8 a.m. IOP after a single low dose of ENV515 was 19.4 mmHg over the nine-month period.

The nine-month data showed ENV515 to be well tolerated with no serious adverse events, no changes in corneal endothelial cell counts, and no changes in corneal thickness. The most common adverse event was early-onset transient hyperemia related to the dosing procedure.

Envisia president Benjamin Yerxa said the company plans to begin enrollment in a new cohort of this Phase II trial by year-end to evaluate the high-dosage formulation of ENV515 compared with travoprost (Travatan Z, Alcon) with a duration greater than nine months.

– OIS Correspondent Larry Haimovitch contributed to this report.