At OIS: Rarities and Thought Provokers
An eye drop with the potential to fix, albeit temporarily, presbyopia. An artificial endothelial cornea, ready for trial. A neurostimulation device for dry eye in which all 180 trial participants experienced a reduction in symptoms. Two Phase III trials – one on the horizon, for ocular graft versus host designation, the other, already in progress, to impede the advancement of myopia.
Other innovations like these, with clinical trials on their horizons, were also presented at OIS@AAO 2019 in San Francisco. In its 11th year, the Ophthalmic Innovation Summit continues to attract ever larger numbers of attendees; this year, the number topped 1,200. (For those who wish to see the presentations, download the OIS PowerPoints.)
Orasis Pharmaceuticals is testing an eyedrop that corrects presbyopia on a temporary basis. Its operating principle is to modulate the pupil size and therefore increase the depth of vision via a “pinhole effect.” In a Phase IIb study, the product met its primary and secondary endpoints: for the primary, it was a best corrected visual acuity gain of three lines from baseline. Company CEO Elad Kedar said the Phase III key endpoints have already been evaluated in the Phase IIb study.
EyeYon Medical, the multinational company that won the 2014 ESCRS and 2018 ASCRS Top Innovation prize for its artificial endothelial cornea, said its device is ready for trial. The product is designed to treat chronic corneal edema. Company CEO Nahum Ferera stated during a morning Breakout Session that results of the multicenter trial, in Europe and Israel, are expected about this time next year.
Olympic Pharmaceuticals announced results from its Tear 1 study for dry eye. Its neurostimulation device is applied to the side of the nose to stimulate the nasolacrimal reflex. CEO Michael Gertner said from the podium that all 108 trial participants showed improvement in their dry eye symptoms, beyond natural tear production. For example, on day 0 the total meibomian score was 12.1; by day 30, it was 18.8. The study’s primary endpoint was 30 days with a static regimen.
Ocugen has plans for a Phase III trial to test its small-molecule OCU300 (brimonidine 0.18% OcuNanoE) for the treatment of ocular graft versus host disease (oGVHD). Company CEO Shankar Musunuri said a small number of people who receive allogeneic bone marrow transplants develop an autoimmune disease in which the donor’s leukocytes, which normally attack foreign substances, attack the recipient’s ocular tissue, making it red and irritated, causing possible scarring, and can even threaten vision loss. The 84-day trial will enroll about 60 patients.
SightGlass Vision has rolled out its Phase III trial. CYPRESS (Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study for myopia prevention progression) has 255 young (6 to 10 years old) myopes enrolled in 14 sites across North America, said CMO Joe Rappon, MD. Dr. Rappon explained that the study has co-primary endpoints: a change from the baseline axial length and the cycloplegic autorefraction. The science behind the lens is based on work showing that retinal contrast-signaling abnormalities are partially responsible for myopia.
Allegro Ophthalmics’ risuteganib, an integrin-regulating compound, shows a reversal in vision loss in dry age-related macular degeneration (AMD) with a statistical significance from baseline, said company President and CEO Vicken Karageozian, MD, during an Innovation Showcase.
In Allegro’s Phase IIa intermediate dry AMD study, 25 patients were dosed with risuteganib 1.0 mg and compared with the 14 patients in the sham/crossover group. The primary endpoint was an 8+ letter best-corrected visual acuity gain at week 28 compared with sham at week 12. Of the patients, 48% gained at least 8 letters, Dr. Karageozian said, compared with 7.1% in the sham group.
As always in the afternoon of an OIS@AAO summit, subject matter experts discussed the present and peered into the future.
Healthcare Leaders’ Perspectives Panel Moderator James Mazzo, Global President Ophthalmic Devices, Carl Zeiss Meditec, said industry should stop saying that healthcare is “going digital” considering it has been investing in digital healthcare for a few years: more than $30 billion since 2013. He asked the panel members to discuss how they are strategically planning for the next decade of healthcare.
Michael Kaschke, PhD, President and CEO of ZEISS Group; Ashley McEvoy, EVP, Worldwide Chair, Medical Devices, Johnson & Johnson; Peter McDonnell, MD, Professor and Director, Wilmer Eye Institute, Johns Hopkins University School of Medicine; and David Pyott, former Chair and CEO, Allergan, said that as artificial intelligence takes over the more routine responsibilities that doctors have now, and as other technologies change, they’ll be able to focus more on patient interaction. The panel said the patient population will include more young patients. They will have higher expectations and want to be more involved with their treatment, which technology will allow. Virtual office visits could give more patients to access to healthcare.
In the Private Financing report, Jonathan Norris, Managing Director, Silicon Valley Bank, noted that billion-dollar exits in the last three years have driven strong healthcare fundraising, and that an active exit market has led to a steady increase in venture capital fundraising. He also said that crossover investors have created large pre-IPO values in biopharma, in part because they’re seeing that the markets are receptive to later-stage devices, and in general IPO pre-money valuations are up.
J.P. Peltier, Global Group Head, Healthcare Investment Banking at Piper Jaffray, said the public market’s last 126 months have been the longest running bull market in US history. Now, however, investors lack conviction as to what to do next; they are in limbo. The main reasons: the volatility of the US markets fed by the trade war with China and the upcoming presidential election.
He said that 2019 IPO activity remains strong and that the life sciences IPO market is shifting to earlier-stage companies. For 2019, 70% of life sciences IPO investors are crossover investors, and 36% are insiders.
Michael Lachman, President of EyeQ Research, updated attendees on the OIS Index. It’s been a rough six months, he said, as half the stocks in the index declined by at least 20%, with 8 of 35 down greater than 40%. He agreed with Peltier’s assessment of the market’s volatility.
Medical device stocks have done better than biotech stocks, Lachman said. Of the top 10 OIS Index stocks for the past three years, the three device stocks have outperformed all seven of the biopharma stocks.
As for the 2019 Winning Pitch challenges awardees: The ASCRS 2019 winner is Bala Ambati, MD, PhD, President, iVeena Delivery Systems, for the IVMED-80 eye drop, and Jeffrey G. Gross, MD, Managing Partner, BioGenware and founder of the Carolina Retina Center, for the Speculet, a newly designed speculum.
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