‘A Very Interesting Time’ and Other Insights from OIS Virtual Public Company Showcase

In this time of virtual meetings, the Ophthalmology Innovation Summit (OIS) continues to deliver information and foster innovation. Last week’s OIS Virtual Public Company Showcase featured presentations of developing technologies, and gave attendees an opportunity to interact with the presenters and each other.

One of the cornerstones of OIS is the interaction between participants, to stimulate thinking and look for effective partnerships. William J. Link, PhD, managing partner, Flying L Partners, reflected this in his introductory comments saying, “As always, I encourage everyone to use this as an opportunity to network and connect with each other, both during and after the presentations.”

Although that’s arguably the element most missing in online meetings, the format of this virtual conference allowed for that important interaction. Chat windows enabled questions from the viewers to the presenters, as well as conversation between those attending. A list of participants was also available, with a messaging component for personal communication.

Overview of the Healthcare Public Market
Udit Patel, executive director, healthcare investment banking at Piper Sandler, gave an overview of the healthcare public market. “The public markets have gone through a very interesting time, to say the least,” he said, adding that the Fed’s quick and decisive response to the current situation was instrumental in jump-starting the recovery.

Patel said that in just over two months the market recovered to about 87% of its pre-pandemic peak. But, he added, we’re not in the clear; volatility remains at elevated levels. He’s “cautiously optimistic going into the second half of the year,” and explained that the broader markets are back on track, but potential headwinds, including the enduring COVID-19 pandemic and the upcoming presidential election, lie ahead.

OIS Index Performance
Michael Lachman, president of EyeQ Research, provided an update of the OIS Index, which tracks the performance of publicly traded companies in ophthalmology. In the first half of 2020, the largest positive drivers for the index were STAAR Surgical, Adverum Biotechnologies, Kala Pharmaceuticals, and Ocular Therapeutix. Lachman noted that Aerpio Pharmaceuticals was “another big gainer, but with a smaller impact on the index due to its lower weighting”; the company reported developments directly targeting treatment of COVID-19.

Lachman said that negative drivers, due to the impact of COVID-19, include Bausch Health, Aerie Pharmaceuticals, Carl Zeiss Meditec, and Glaukos.

Company Showcase
Oyster Point Pharma: President and CEO Jeffrey Nau, PhD, presented data from the company’s Phase III ONSET-2 clinical trial of the OC-01 nasal spray. With a novel route of administration and a novel mechanism of action, OC-01 stimulates the trigeminal nerve resulting in natural tear film production, and has a rapid onset of action. It’s preservative free, has demonstrated improvement in tear production, and has a favorable tolerability profile, with the most common adverse event being transient sneezing.

Dr. Nau explained that lacrimal gland dysfunction can lead to dry-eye disease. OC-01 nasal spray, delivered to both nostrils, sends a signal to the central nervous system to stimulate lacrimal gland function and reestablish tear-film homeostasis. Phase III results showed improvement in both signs and symptoms of dry-eye disease. The company plans to submit a New Drug Application to the US Food and Drug Administration in the second half of the year.

Aldeyra Therapeutics: CEO, President, and Director Todd Brady, MD, PhD, explained the company’s novel immunology-based approach to treatment of ocular disease. Instead of the traditional approach of activating or blocking a single target, which can lead to toxicity, Aldeyra is taking more of a “dimmer-switch” approach. This, Dr. Brady said, allows infinite control between on and off states, and modulation of multiple targets. He discussed the company’s “diverse pipeline spread across ocular and systemic diseases,” including two products in Phase III testing: reproxalap, in development for both dry-eye disease and allergic conjunctivitis; and ADX-2191 for proliferative vitreoretinopathy.

Eyenovia: Vice President Michael Rowe reported Eyenovia is focusing on areas where its technology may bring a particular medical benefit. Programs address progressive myopia (MicroPine), symptomatic treatment of presbyopia (MicroLine), and a unique fixed-combination mydriatic (MicroStat) that, if approved, would allow for touchless dilation. That, Rowe pointed out, may be of greater interest now due to COVID-19.

Eyenovia is enrolling patients for the Phase III CHAPERONE study for progressive myopia, and will begin presbyopia studies later this year, with an expectation to finish both by mid-2021. A New Drug Application (NDA) for MicroStat is planned for later this year.

These products are being developed for delivery with Eyenovia’s Optejet, which utilizes microdosing technology designed for optimal drug delivery, eliminating drug overflow that is common with eye drops.

Ocular Therapeutix: President and CEO Antony Mattessich reported on programs in the pipeline for retinal diseases, glaucoma, ocular surface disease, and post-surgical pain and inflammation. In addition to exploring other assets to add to its pipeline, the company is looking at whether combining its delivery technology with an existing therapeutic might yield a standard-of-care product. In retina, the key unmet need is durability, Mattessich said, and Ocular Therapeutix has two products that he said have the potential to set the standard for durability in anti-VEGF treatments: OTX-TKI, a sustained-release intravitreal implant; and OTX-AFS, a collaboration with Regeneron Pharmaceuticals for a sustained-release formulation of Eylea (aflibercept).

In glaucoma, Ocular Therapeutix is pursuing OTX-TIC, an intracameral injection of a travoprost implant designed to last at least six months. In dry eye, OTX-CSI is a cyclosporine intracanalicular insert designed to last three months, and OTX-DED is a dexamethasone-containing insert. For post-surgical pain and inflammation, Dextenza is an FDA-approved dexamethasone insert designed to be a hands-free alternative to eye drops.

EyePoint Pharmaceuticals: Chief Strategic Scientific Officer Jay Duker, MD, who’s also director of the New England Eye Center, reported on two commercial products: YUTIQ for chronic non-infectious uveitis; and DEXYCU, for inflammation following intraocular surgery. Both are based on EyePoint’s proprietary validated technologies, Durasert and Verisome.

The company’s advancing pipeline in ocular disease includes EYP-1901, a sustained-release anti-VEGF treatment initially tested for wet age-related macular degeneration (AMD), and YUTIQ-50, an intended six-month treatment for chronic non-infectious uveitis, among other programs. Dr. Duker also noted that EyePoint has a long-standing partnership with Alimera Sciences for Iluvien for macular edema.

Zoom-Like to the End
To close the day, Emmett T. Cunningham Jr., MD, PhD, MPH, senior managing director, Blackstone Life Sciences, moderated a Zoom-style panel discussion with all the presenters. Following the close, the chat and messaging functions were left open for an hour to allow networking to continue.