Veeral Sheth, MD, MBA, FASRS, FACS

New Insight: Exploring ENCELTO for MacTel with Rich Small, CEO of Neurotech

In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Rich Small, chief executive officer of Neurotech, about the recent 

 approval of revakinagene taroretcel-lwey (ENCELTO), a groundbreaking encapsulated cell therapy for 

This approval marked the first and only FDA–approved treatment for MacTel, a neurodegenerative disease of the retina that can cause progressive and irreversible vision loss.

“Today marks an extraordinary milestone for patients, the retina community, and Neurotech,” Small said in a statement. “I would like to express my gratitude to clinical study participants, clinical investigators and their teams, and the entire Neurotech organization who have helped make this a reality.”

Speaking with Sheth, Small recounted the long journey of Neurotech, which began in 2007, emphasizing the perseverance required to bring ENCELTO to market. He detailed his transition from Chief Financial Officer to CEO in 2016 and highlighted his team’s commitment, many of whom have been with the company for over a decade.

The conversation explored the scientific foundation of ENCELTO, which uses genetically modified cells to release neurotrophic factors that protect photoreceptors in the retina. Unlike previous treatments that relied on best corrected visual acuity (BCVA) as a clinical endpoint, ENCELTO’s approval was enabled by advancements in imaging technology that allowed for direct measurement of photoreceptor health. Small explained how Neurotech was pivotal in shifting FDA standards to accept these structural endpoints, paving the way for future therapies targeting slow-progressing retinal diseases.

Sheth and Small discussed the ideal patient profile for ENCELTO, noting that early intervention is key to preserving vision in MacTel patients. Small describes the treatment’s durability, citing cases where implants remained viable for approximately 14 years. He also outlined the surgical implantation process, emphasizing its straightforward nature and the company’s focus on proper physician training.

With ENCELTO’s approval secured, Small indicated the next step is widespread adoption, introducing 

 as a patient service hub designed to streamline diagnosis, treatment, and access to care.

Sheth underscored the significance of this approval, noting that for the first time, clinicians have an option for patients who previously had no treatment alternatives. Reflecting on the impact of perseverance in biotech innovation, and the hope ENCELTO brings to patients, Small expressed pride in Neurotech’s achievement and excitement about delivering this novel therapy to those in need.

Every episode of New Insight is available on HCPLive.com. Watch full episodes on our YouTube channel and listen wherever you get your podcasts.

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Veeral Sheth, MD, is joined by the CEO of Neurotech to discuss the historic approval of revakinagene taroretcel (ENCELTO) for macular telangiectasia type 2.

New Insight: A Deep Dive into the Oculis Pipeline with Riad Sherif, MD

 Riad Sherif's Journey from Physician to CEO


 Challenges of Balancing Medical and Business Roles


 Oculis' Portfolio and Recent Developments


, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, spoke with Riad Sherif, MD, CEO of Oculis, about the company's groundbreaking advancements in 

Sherif shared his journey from physician to industry leader, detailing his experiences at Sanofi, Novartis, and Alcon before transitioning to venture investment and eventually leading Oculis. He highlighted how his medical background informs his leadership approach, emphasizing a patient-first philosophy that drives innovation and sustainable growth in drug development.

The discussion delved into Oculis' clinical pipeline, particularly OCS-05, a neuroprotective agent demonstrating promising results in acute optic neuritis. The Phase 2 ACUITY trial showed that OCS-05 preserved retinal ganglion cells (RGCs), reduced axonal loss, and improved low-contrast visual acuity. Importantly, patients receiving OCS-05 experienced significantly fewer multiple sclerosis relapses, suggesting broader neuroprotective potential. Administered intravenously alongside corticosteroids, the therapy could represent a paradigm shift in preserving vision in acute optic neuritis and beyond.

Sheth and Sherif also explored Oculis' lead candidate, OCS-01, a topical treatment for diabetic macular edema (DME) that uses an OPTIREACH® formulation of high-concentration dexamethasone to penetrate the retina. With two ongoing Phase 3 trials (DIAMOND 1 and 2), OCS-01 has the potential to offer a non-invasive alternative or adjunct to intravitreal injections, expanding treatment options for patients with DME. Additionally, Oculis' OCS-02, a TNF inhibitor for dry eye disease (DED), integrates a biomarker-driven precision medicine approach, ensuring targeted therapy for responders and potentially revolutionizing dry eye treatment.

Sherif provided insight into Oculis' international operations, highlighting its dual listings in the US and Iceland, the latter a strategic decision to engage Icelandic investors and maintain strong ties to the company’s research roots. He underscored the importance of assembling a high-caliber, mission-driven team to ensure successful execution in an unpredictable scientific landscape.

Looking ahead, Sherif noted that Oculis is focused on executing its clinical programs, particularly finalizing patient randomization in the DIAMOND trials, advancing precision medicine for inflammation, and expanding indications for OCS-05 in neuroprotection. In particular, he envisioned OCS-05 as a potential game-changer addressing significant unmet needs in ophthalmology by preserving vision and improving the quality of life for patients facing vision-threatening diseases.

Every episode of New Insight is available on HCPLive.com. Watch full episodes on our

and listen wherever you get your podcasts. Please direct all podcast-related inquiries to producer Connor Iapoce (ciapoce@mjhlifesciences.com)!

Veeral Sheth, MD, is joined by the CEO of Oculis to discuss the company's ophthalmic pipeline, including OCS-01 for DME and OCS-05 for acute optic neuritis.

New Insight: A Look at Qlosi for Presbyopia with Elad Kedar, MBA

 Elad Kedar's Background and Company Growth

 Transition from Product Development to Team Building

In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, explored the approval and impending launch of Qlosi (pilocarpine HCL ophthalmic solution) 0.4%, a groundbreaking pharmacologic option for managing 

, with Elad Kedar, MBA, chief executive officer of Orasis Pharmaceuticals.

A condition that affects nearly all adults as they age, presbyopia is characterized by the gradual loss of near vision due to reduced lens elasticity. Sheth and Kedar highlighted the significance of finding non-invasive treatment options for this pervasive issue, given the limitations of traditional solutions like reading glasses or surgical interventions.

In October 2023, the US Food and Drug Administration (FDA) approved Qlosi, a preservative-free, low-dose eye drop for presbyopia, based on strong efficacy, safety, and tolerability data reported in the pivotal Phase 3 NEAR-1 and NEAR-2 clinical trials. On Day 8, patients treated with Qlosi achieved statistically significant ≥3-line gain in distance-corrected near visual acuity (DCNVA) and no loss of ≥1-line in distance visual acuity.

Sheth and Kedar delved into Qlosi’s innovative mechanism of action, emphasizing how it leverages a unique pharmacologic approach to improve near vision. By modulating pupil dynamics, Qlosi enhances the depth of focus, effectively allowing patients to perform near-vision tasks without additional aids. Together, Sheth and Kedar walked through the drug’s clinical development journey, highlighting his journey through the founding of Orasis and the company’s name in Greek, meaning “good vision or sight.”

The discussion included insights into the populations most likely to benefit from Qlosi and the practical considerations for prescribing. Sheth offered a nuanced take on how this therapy could fit into the broader landscape of presbyopia management, addressing questions about patient education, adherence, and expectations.

Sheth also shared his perspective on the potential impact of Qlosi on clinical practice, noting that its ease of use and non-invasive nature could appeal to both patients and providers. He reflected on how treatments like Qlosi are part of a broader trend toward personalized medicine, focusing on solutions that improve the quality of life for aging populations.

This episode concluded with a thoughtful look at future research directions and the impending launch of Qlosi. Expected soon, Kedar expressed an interest in sharing more details on the product and its position in the presbyopia treatment landscape once the drug comes to market.

Every episode of New Insight is available on HCPLive.com. Watch full episodes on our 

 and listen wherever you get your podcasts. Direct all podcast-related inquiries to show producer Connor Iapoce (ciapoce@mjhlifesciences.com) and keep an eye out for more from New Insight!

In this episode, Veeral Sheth, MD, is joined by the CEO of Orasis Pharmaceuticals to discuss Qlosi, a preservative-free, low-dose eye drop FDA-approved for presbyopia.

Veeral Sheth, MD, MBA discusses the 3 improvements needed for the future of treating patients with geographic atrophy. 

The Future of Geographic Atrophy Treatment

: I think with geographic atrophy, we're in the beginning stages of therapeutics. This is like inning number one of the last game of the World Series. We're finally at a point where we have a therapeutic, that does something, right? After years and years of looking for therapeutics, in clinical trials that just didn't pan out. As a clinician who's been involved in a lot of those clinical trials, I'm very excited about the fact that we got something past the finish line, but we know that this is the first step.

While we have something that's efficacious, it requires a heavy treatment burden, right? We can slow the disease down, but I would love to be able to slow the disease down with maybe a more durable agent, something that doesn't need to be given every month or two. That’s, I think, what patients are going to demand over time. We've seen that with our wet AMD and DME patients, and I think this is no different.

I think that in the future of treating geographic atrophy, we're really going to look for kind of three improvements. One is going to be efficacy – we need agents that are going to further slow down the damage being done, and maybe one day even reverse the damage, but that's even further down the road. But, better efficacy. Right now, we're talking 20 to 30% slowing down, maybe we get to 40 or 50%, maybe we get to 70 or 80%. I think it's something that we have to aim towards.

The second thing is durability. How can we achieve these types of endpoints, but with fewer injections, or maybe even alternate routes? Right now, there are people out there looking at gene therapy as an example. This is a perfect place for gene therapy because you can treat potentially one time and get a prolonged treatment effect from that. That’s one of the things that we're looking at, and potentially something that's not as far down the road.

Then, safety. The third thing we look for is safety. We want to make sure that whatever treatments we continue to push forward that they are as safe, if not safer than whatever kind of bar has been set. Right now the bar has been set by SYFOVRE and IZERVAY. We have got to continue to kind of push those three factors and come up with good solutions for patients. We've done it before with neovascular AMD and DME, and I have no doubt we're going to do that for geographic atrophy as well.

Veeral Sheth, MD, MBA, FASRS, FACS

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