In this episode of the OIS Podcast, host Dr. Firas Rahhal, along with expert panelists, Dr. Robert Bhisitkul, Dr. Alan Franklin and Dr. Paul Karpecki at OIS XIII, takes listeners on a deep dive into the transformative landscape of oral therapies in retina treatment, challenging the conventional approach dominated by eye injections. Tune in as they explore the groundbreaking realm of oral treatments and shed light on their novelty in retinal care.

The discussions are comprehensive, covering key aspects such as:

•  Novelty in Retina Treatment
•  Three-Step Improvement and Long-Term Vision Protection
•  Optimism for Prevention and Early Intervention
•  Clinical Trial Parameters and Market Potential
•  Diverse Mechanisms in Focus

Don't miss out on this enlightening episode that explores the dynamic landscape of oral therapies, offering a fresh perspective on their potential to revolutionize the field of ophthalmology. Stay informed and engaged with OIS XIII discussions, as experts discuss the exciting possibilities that oral therapies bring to the forefront of retinal treatment.

ViaLase, a clinical stage medical technology company located in Aliso Viejo, CA is focused on disrupting the conventional glaucoma treatment paradigm with the introduction of a truly noninvasive image-guided femtosecond laser treatment that enhances glaucoma patient care.

With a leadership team that has vast experience developing, designing, manufacturing, and commercializing the first femtosecond lasers for ophthalmic surgery for refractive and cataract patients, ViaLase is now bringing that expertise and innovation to glaucoma patients.

In this episode, Chief Commercialization Officer, Shawn O’Neil chats with OIS host Dr. Rob Rothman and discusses his successful product launches and instrumental contributions to ViaLase's commercialization strategy, their unique reimbursement strategy, the treatment's durability over time, enhancing its long-term impact, and much more.

Tune in and see how ViaLase plans to bring this revolutionary treatment to glaucoma patients across the globe.

Resources
ViaLase: https://www.vialase.com
Sean O’Neil: LinkedIn
Robert Rothman, MD ois.net/robert-rothman-md

Opthea, an Australian based biopharmaceutical company is dedicated to transforming retinal disease treatments and elevating patients' vision and quality of life. Join Firas Rahal, MD, in a captivating episode as he engages with Opthea's Founder and Chief Innovation Officer, Megan Baldwin, PhD.

Explore the compelling journey from oncology to ophthalmology, unraveling strategic decisions, navigating competitive landscapes, and achieving triumphs in clinical trials. Dr. Baldwin unfolds her remarkable career trajectory, from a PhD at the University of Melbourne to pivotal roles at Genentech and the Ludwig Institute for Cancer Research.

Tune in for exclusive insights, including:

• Opthea's strategic approach to revolutionizing eye care
• Clinical Trials: A deep dive into their success and impact
• Comparison with Other Drugs: Differentiating factors and unique contributions
• Future Directions: Exploring new horizons and clinical opportunities
• Commercialization Timeline: Anticipated milestones and FDA approval strategies

Listen now for a compelling journey through Opthea's vision as they continue to shape the landscape of ophthalmological advancements.

Opthea: Opthea.com
Megan Baldwin, PhD: LinkedIn
Firas Rahal, MD ois.net/robert-rothman-md

Harrow isn’t a household name (yet), but eye care professionals have trusted its products for over a decade.

The Nashville-based company produces Dexycu, an intraocular steroid; Iopidine for intraocular pressure control; and most recently, five Novartis products that Harrow acquired in December 2022.

Rob Rothman, MD, caught up with Harrow founder and CEO Mark Baum to find out how he grew the company from worse than nothing—he acquired, restructured, and reorganized a company in bankruptcy in 2011—to a publicly traded organization with an enterprise value of $750 million.

Baum describes Harrow as a “consortium of entrepreneurs.” That consortium includes:

• Eton Pharmaceuticals, developing products to treat rare disease
• Surface Ophthalmics, developing preservative-free products to treat dry eye disease and post-operative pain
• Melt Pharmaceuticals, which produces MKO Melt, an FDA-approved analgesic

Harrow built its business off compounded medications. By meeting needs of physicians in that way, it grew from zero to over 10,000 customers in a relatively short time.

Looking ahead, Baum wants to build Harrow’s portfolio and its brand recognition, all while abiding by the company’s mission: to give patients access to affordable ophthalmic medications.

Listen to the podcast today to discover:

• More about Baum’s career path, including his background as a lawyer and investor, his move into business, and the event that prompted him to reorganize and restructure what is now Harrow.
• Harrow’s corporate philosophy and why Baum considers the company a consortium of entrepreneurs.
• How Harrow grew from zero to over 10,000 customers in a few years.
• The secret to Harrow’s success, including how it profits from smaller, but no less important, assets.
• What’s next for Harrow, including the upcoming launch of Vevye, a dry eye drop based on Novaliq’s proprietary EyeSol water-free technology.
• How Harrow plans to grow within the next five years, and whether that includes developing its own products.

Resources

Harrow:                       harrow.com

Mark Baum:                marklbaum.com and on LinkedIn

Rob Rothman, MD      ois.net/robert-rothman-md

Endogena Therapeutics has developed a novel approach to regenerative medicine that’s not only scientifically compelling, but practical.

Endogena’s technology unlocks the body’s own stem cells for controlled tissue repair by small molecules. Its products use a dosing schedule that could move easily into the system already in place for intravitreal injections.

CEO Matthias Steger, PhD, MBA, sat down with retina specialist Firas Rahhal, MD, to discuss the Endogena approach in depth. They also discuss the compelling results seen so far in both animal models and in patients.

The company’s lead candidate is being developed to treat retinitis pigmentosa. The product has received Orphan Drug and Fast Track Designation from the FDA and is moving through Phase IIa clinical trials. Dr. Steger says the company expects to have data to share in early 2024. It’s also submitting an investigational new drug (IND) application for an age-related macular degeneration treatment later this month.

Listen to the podcast today to discover:

• The “serendipitous discoveries” that moved Dr. Steger’s career from applied science to financial analyst to regenerative medicine start-up cofounder.
• The stem cell approach that Dr. Steger and team are applying to Endogena products and how it differs from implanted stem cell programs.
• How Endogena applies its novel drug discovery approach to neurodegenerative retinal disease by rebuilding photoreceptors.
• The type and location of retinal stem cells used for Endogena treatments.
• The types of molecules used to stimulate or induce an effect from the stem cells.
• The incredible results the technology produced in mice—regenerating the outer retinal layer “nearly back to normal” and regenerating the rods and cones.
• The dosing schedule for the RP product and what happens after dosing is complete.
• How Endogena plans to fund its current and upcoming programs. Where has the funding come from to date? And for upcoming clinical trials?

Resources

Endogena Therapeutics          https://endogena.com

Firas Rahhal, MD                     https://ois.net/firas-m-rahhal-md

“You can see and feel a buzz within the company right now,” said Andrew Stewart, President, Global Pharmaceuticals and International Consumer, at Bausch + Lomb.

Bausch + Lomb’s current momentum stems not only from new leadership, but also from recent collaborations, partnerships, and acquisitions.

Stewart and Yehia Hashad, MD, Executive Vice President of Research & Development and Chief Medical Officer, join host Paul Karpecki, OD, to discuss these activities. Miebo, the first-in-class dry eye asset for the treatment of evaporative dry eye, tops the list.

Looking ahead, Stewart and Dr. Hashad said the company is lasering its focus to tackle more unmet medical needs in eye care. The company intends to build on its legacy of innovation in drug delivery, in MOAs, and in developing new molecular entities.

What’s next for the most recognized name in eye care?

Topics discussed include:

• Why Stewart shifted into commercial from R&D, and why Dr. Hashad moved from clinical practice to R&D.
• How Bausch + Lomb leadership is looking at the future for a company with a 170-year legacy.
• Bausch + Lomb’s holistic approach to dry eye disease and treatment.
• The company’s thinking behind acquiring the rights from Novaliq to pursue development of what is now Miebo.
• The importance of addressing unmet needs with respect to the Bausch pipeline.
• What excites Dr. Hashad and Stewart about the company right now.
• Where they would like to see Bausch + Lomb in the next three to five years, including for Miebo, for ocular surface disease treatments, and for eye care.

Resources

Miebo                         https://www.miebo.com

Andrew Stewart          https://www.bausch.com/about-bausch-lomb/leadership-team

Yehia Hashad, MD       https://www.bausch.com/about-bausch-lomb/leadership-team

Paul Karpecki, OD       https://ois.net/paul-karpecki-od

OIS Podcast host Carey Powers caught up with four ophthalmology execs and one principal investigator to talk about some of the most exciting developments in retina R&D.

Her guests include:

• Houman David Hemmati, MD, PhD, Cofounder and Chief Medical Officer of Optigo Biotherapeutics   
• Michael Tsipursky, MD, CEO and Cofounder of Revive Biotech
• Michael Singer, MD, Clinical Professor of Ophthalmology at University of Texas Health Science Center, Director of Clinical Research at Medical Center Ophthalmology Associates, and Principal Investigator for Unity Biotechnology’s BEHOLD trial
• Samarendra Mohanty, PhD, President and Cofounder; and Sulagna Bhattacharya, CEO and Cofounder of Nanoscope Therapeutics

Optigo is developing binders intended to extend the duration of top-performing intravitreal drugs without compromising efficacy. The company has already had promising results in clinical trials with aflibercept. What’s next?

Revive Biotech focuses on central retinal artery occlusion. Its products work by injecting oxygen-loaded nanobubbles into the eye intravitreally. Preclinical studies have advanced through proof of concept. Nanobubbles?

Dr. Singer is a principal investigator in Unity Biotechnology’s clinical trial for UBX-1325, a therapeutic in development to treat diabetic macular edema and wet AMD. If approved, the product could work as an adjunct to anti-VEGF therapies.

Nanoscope Therapeutics is developing gene therapies that focus on ambient light-sensitive molecules to treat inherited and acquired retinal diseases. Its lead product, MCO-010, is moving through Phase II trials. Why ambient light?

Tune in to hear today’s experts discuss:

• How Optigo plans to extend the duration of aflibercept
• The impact of extending duration activity on patients, physicians, and payers
• What Optigo plans to accomplish over the next 12 months
• What’s behind Revive Biotech’s proprietary technology and what makes it unique.
• The milestones it has completed so far with relation to clinical trials, intellectual property, and funding
• The new class of therapeutics being developed by Unity Biotechnology
• The data released so far on the UBX-1325 BEHOLD trial
• If approved, the impact of UBX-1325—an agent that may potentially extend the life of anti-VEGF therapies—on clinical practice
• The potential impact of Nanoscope Therapeutics’s MCO-010 on patient communities
• The feedback reported from clinical trial participants
• The critical milestones Nanoscope Therapeutics intends to achieve over the next year

[Listen Now]

OIS Podcast host Carey Powers speaks with four CEOs from leading retina-focus companies to talk about all things innovation. Her guests include:

•  Kerrie Brady, BPharm, President and CEO of OcuTerra
•  Rich Small, CEO of NeuroTech Pharmaceuticals
•  Kester Nahen, PhD, CEO of Notal Vision
•  Brad Doerschuk, President and CEO of InFocus Clinical

OcuTerra is developing OTT166, a novel small molecule designed to treat diabetic retinopathy.

The product is getting attention because it can deliver product to the retina via an eye drop application, said Kerrie Brady, BPharm, CEO of OcuTerra.

The company has completed enrollment for a Phase II trial in 225 patients with diabetic retinopathy. They hope to have topline results in early 2024.

Next up: Rich Small, CEO of NeuroTech Pharmaceuticals. The company’s Encapsulated Cell Therapy (ECT) technology enables continuous production of therapeutic proteins to the eye.

ECT is central to NT-501, a product being developed to treat macular telangiectasia (MacTel) as well as glaucoma.

Third in line: Kester Nahen, PhD, CEO of Notal Vision. Notal Vision provides remote patient monitoring services for patients with retinal diseases. Its teleconnected devices use AI and analytics to give physicians insight into retinal activity in between patient visits. The company is also developing a home OCT device that has received Breakthrough Device designation from the FDA.

Brad Doerschuk, CEO of InFocus Clinical, closes out the podcast by discussing the value of contracting with a specialist. He says InFocus is the first and only retina specialty CRO. The depth of ophthalmology expertise at the organization is hard to find, he says, and it enables the company to offer comprehensive, high-touch services to its clients.

Other topics covered on today’s episode include:

•  The mechanism of action of OcuTerra’s OTT166
•  The opportunities that arise from a noninvasive local therapy and how this type of therapy could transform the standard of care.
•  How NeuroTech’s ECT platform delivers proteins to the back of the eye.
•  Details on NT-501’s Phase II and III studies.
•  What 10 years of real-world data revealed about patients that use Notal Vision’s ForeseeHome.
•  How Notal Vision’s Home OCT is helping clinical trial investigators.
•  How Home OCT aids long-term treatment.
•  What sets InFocus Clinical apart from other CROs that run ophthalmology studies.
•  The latest additions to InFocus Clinical’s partnership program

[Listen Now]

Resources

OcuTerra Therapeutics           ocuterratx.com

NeuroTech                              neurotechpharmaceuticals.com

Notal Vision                            notalvision.com

InFocus Clinical                       infocusclinical.com

Carey Powers:                          ois.net/carey-powers

For more on at-home OCT, give Episode #377 with Anat Loewenstein, MD, a listen. 
https://ois.net/the-latest-on-at-home-oct-with-anat-loewenstein-md

At-home OCT enables daily monitoring of patients with neovasular age-related macular degeneration (AMD) and other patients that need a lot of follow-ups.

With host Carey Powers, Dr. Anat Loewenstein dives into at-home OCT innovation, application, and adoption.

Dr. Loewenstein is Head of the Department of Ophthalmology and Vice Dean at Tel Aviv Medical Center. She’s also a fellowship-trained vitreoretinal surgeon and has been heavily involved in research related to early AMD detection.

Why all the fuss about at-home OCT? An at-home monitoring solution will potentially lessen the number of appointments for patients who don’t need them. More-frequent monitoring could also help catch disease changes sooner so doctors can facilitate treatment asap.

Listen to the podcast today to discover:

• How at-home OCT works and the role artificial intelligence (AI) plays in image analysis.
• The patient experience when using at-home OCT.
• How disease activity alerts are delivered from the at-home device to the physician.
• Once a physician receives an alert, steps to take to get the patient into the clinic right away.
• The status of products closest to FDA approval, such as Notal Home OCT from Notal Vision.
• Dr. Loewenstein’s thoughts on the global health implications of at-home OCT.

[Listen Now]

Resources

Anat Loewenstein: linkedin.com/in/anat-loewenstein-b48a595

Carey Powers: ois.net/carey-powers

Keith Valentine is the first and only visually impaired head of a national sight loss organization in the UK.

As the President and CEO of Vision Foundation, London’s leading sight loss charity, Valentine guides an organization that provides services for blind and visually impaired people countrywide. He also has plans to increase the organization’s research commitment.

In March 2023, Vision Foundation merged with Fight for Sight, the leading UK charity dedicated to stopping sight loss through pioneering research. Combined with Vision Foundation’s legacy as a service provider, the new organization intends to make a bigger impact on both science and services.

Valentine said out of all the sight loss funding currently available in the UK, the majority goes toward much-needed services. Only a small slice is available for research. Vision Foundation currently distributes about £2 million per year to fund research, and it’s one of the larger UK sight loss charities.

Valentine told host Rob Rothman, MD, the deficit of research funding “will be felt by the investor community and the scientific community. It will affect the sustainability of science in the UK and the ability to attract people to ophthalmology as a profession.”

Valentine intends to use what he learned in both the private and non-profit sectors to avert that deficit.

Listen to the podcast today to discover:

• More about Valentine’s background, including his transition from the private sector to nonprofit sight loss, and how his experience with retinitis pigmentosa influenced his career path.
• The structure and scope of the charitable sight loss sector in the UK, including its approach to funding.
• How Valentine’s experience as a start-up founder influences his role leading a nonprofit.
• How Valentine plans to accelerate Vision Foundation’s scientific investment.
• His thoughts on whether nonprofits could or should benefit financially from their scientific investments and what that would look like.
• The potential and risks involved for nonprofits that invest alongside venture capital firms to advance innovation.

[Listen Now]

Resources

Vision Foundation                   visionfoundation.org.uk

Keith Valentine:                       linkedin.com/in/keith-valentine-70281635

Robert Rothman, MD:            ois.net/robert-rothman-md