Veeral Sheth, MD, MBA, FASRS, FACS

New Insight: Restoring Sight with Nanoscope's MCO-010, with Ashish Patel, PhD, MBA

In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Ashish Patel, PhD, MBA, senior vice president of sales and marketing at Nanoscope Therapeutics, Inc., to discuss the scientific foundation, clinical evidence, and commercial trajectory of Nanoscope Therapeutics’ emerging optogenetic platform. Sheth and Patel focus on its lead program, MCO-010. Patel begins by outlining his path from academic rhodopsin research to leadership roles in major ophthalmology drug launches across Novartis and Bayer, culminating in his move to early-stage biotech and ultimately to Nanoscope. This background frames the conversation on how a decade of gene-therapy experience informs the development of first-in-class optogenetic treatments for advanced retinal degenerations.

Patel describes Nanoscope as a company uniquely positioned at the forefront of vision-restoration therapeutics, driven by founders who originated the underlying optogenetic technology. He emphasizes the profound unmet need among patients with retinitis pigmentosa (RP), Stargardt disease, and potentially geographic atrophy (GA), where photoreceptor loss leaves patients with severe functional blindness and no restorative treatment options. Unlike mutation-specific gene therapies such as RPE65-targeted Luxturna—applicable to only a small fraction of the RP population—optogenetics offers a gene-agnostic, disease-agnostic strategy. MCO-010 delivers a highly sensitive, broadband opsin to bipolar cells, converting them into surrogate photoreceptors capable of supporting functional vision without requiring external goggles or narrow-spectrum light stimulation.

The discussion highlights extensive clinical data across multiple studies. In an early phase 1/2 open-label RP trial, all treated patients achieved meaningful visual improvements that have been maintained for more than five years with no serious treatment-related safety events. The pivotal RESTORE phase 2b/3 trial demonstrated statistically significant mean gains of approximately three lines of vision (0.3 logMAR) versus sham after a single intravitreal injection—an administration route far simpler than subretinal gene-therapy surgery. 3-year follow-up data presented at AAO confirms durable efficacy. Parallel findings in the STARLIGHT phase 2 Stargardt trial showed an average 12-letter gain in patients treated at the macular disease stage, underscoring the platform’s potential across phenotypes of photoreceptor degeneration.

Patel details Nanoscope’s regulatory progress, including Fast Track and Orphan designations from the US Food and Drug Administration (FDA), a successful pre-BLA meeting, and an active rolling BLA submission for RP. With anticipated priority review, MCO-10 could reach the US market as early as next year. Looking ahead, Nanoscope plans a phase 3 Stargardt program (STARGAZE) and a phase 2 GA trial (Genesis), positioning optogenetics as a transformative platform for restoring functional vision in conditions long considered irreversible.

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Veeral Sheth, MD, is joined by the senior vice president of sales and marketing at Nanoscope Therapeutics to discuss the company's trajectory and the MCO-010 program.

New Insight: Restoring Sight With Nanoscope's MCO-010, With Ashish Patel, PhD, MBA

Faricimab Succeeds in AVONELLE-X and SALWEEN Trials for nAMD, With Veeral Sheth, MD

Positive results from the AVONELLE-X and SALWEEN studies of faricimab (Vabysmo) have reinforced the safety, efficacy, and durability over 4 years in 

neovascular age-related macular degeneration (nAMD)

 and over 1 year in polypoidal choroidal vasculopathy (PCV), respectively.

AVONELLE-X was a 2-year open-label extension of the 2-year phase 3 TENAYA and LUCERNE studies of faricimab in nAMD. The trial evaluated the long-term safety and tolerability of faricimab 6 mg, administered via intravitreal injection and at a personalized treatment interval (PTI).

Patients eligible for AVONELLE-X had to have completed either the TENAYA or LUCERNE trial and displayed a difference of <10% in corneal endothelial cell density at screening between both eyes. Patients were excluded if they were pregnant or breastfeeding, had other ocular diseases conferring reasonable suspicion of a disease contraindicating faricimab, had a history of severe allergic reaction or anaphylactic reaction to a biologic agent of the faricimab injections, or were required to continuously use a medication or treatment prohibited by the investigators.

 sat down with Veeral Sheth, MD, director of clinical research at the University of Retina and Macula Associates and clinical assistant professor at the University of Illinois, to discuss the results of these groundbreaking trials. Sheth noted the positive vision outcomes of AVONELLE-X, spotlighting the overall maintenance of vision quality.

“One piece of data I thought was really good coming out of this extension is that, when patients were at 20/40 vision or better at year 1, after treating those patients and fast-forwarding to now, at the end of year 4, 75% of those patients maintain 20/40 or better vision,” Sheth told 

. “This is incredible because that’s something you can immediately translate into how we talk to our patients who come in newly diagnosed.”

SALWEEN was a single-arm, open-label phase 3b/4 study of faricimab in patients with PCV in Asia. It consists of a 28-day screening period and 3 treatment periods: a treatment initiation period (Day 1-Week 12), an individualized constant treatment interval period (Week 20-Week 44/48), and a PTI period (Week 44/48-Week 104). Patients first received 4 doses of faricimab 6 mg, injected in the study eye every 4 weeks. Patients would then receive faricimab 6 mg injections into the study eye at variable intervals, every 4, 8, 12, 16, or 20 weeks.

Patients included in SALWEEN experienced a gain of 8.9 letters in best-corrected visual acuity (BCVA) from baseline, averaged over weeks 40, 44, and 48. At year 1, >50% of patients were assigned to extended 5-month dosing. Additionally, faricimab resolved PCV-related lesions in >60% of patients and led to inactivation of polypoidal lesions in 86% of eyes. Faricimab also exhibited a safety profile consistent with its known safety profile in nAMD.

Sheth highlighted excellent vision outcomes and significant dose extension in SALWEEN, which is a common theme among upcoming ophthalmology treatments in recent years.

“PCV is traditionally more difficult to treat and control and get resolution than typical or standard neovascular AMD,” Sheth said. “These patients did very well in terms of disease control, in terms of vision outcomes, and a majority of patients were actually able to get out to 24-week dosing intervals.”

Roche. New data for Roche’s Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD). September 4, 2025. Accessed October 21, 2025. 

https://www.roche.com/media/releases/med-cor-2025-09-05

Hoffmann-La Roche. A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (AVONELLE-X). ClinicalTrials.gov identifier: NCT04777201. Updated December 11, 2024. Accessed October 21, 2025. 

https://www.clinicaltrials.gov/study/NCT04777201?term=NCT04777201&rank=1

A study evaluating the effectiveness and safety of Faricimab (RO6867461) in participants with polypoidal choroidal vasculopathy. http://isrctn.com/. Published online September 22, 2022. 

Videos

Sheth discusses the positive results in nAMD and PCV, highlighting faricimab’s capacity for dose extension and maintaining vision.

New Insight: The eSight Go with Roland Mattern, eSight Director of Marketing

In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Roland Mattern, director of marketing for eSight, about the development and clinical potential of the eSight Go – a fifth-generation wearable low-vision device designed to enhance central visual function in patients with conditions such as macular degeneration, diabetic retinopathy, and Stargardt’s disease.

Mattern recounted the story of eSight, which began as an engineer’s effort to help his sisters living with Stargardt’s disease. That original version evolved into a sophisticated device that uses a high-resolution camera, dual microdisplays, and proprietary software to project enhanced images onto the user’s functional retinal tissue. The eSight Go offers improved resolution, reduced lag, longer battery life, and a streamlined structure, preserving peripheral vision and optimizing cosmetic appearance.

The conversation explained the importance of mobility and independence in low-vision rehabilitation. Mattern underscored the importance of preserving peripheral vision for spatial navigation while using the enhanced central image only when needed. This hybrid approach enables users to perform daily activities, from reading and facial recognition to cooking and commuting, without relying solely on caregivers.

Sheth and Mattern explained why advanced visual aids like eSight often fall outside the awareness of retina specialists, despite high patient demand. Mattern explained eSight’s strategy to close this gap through conference presence, direct collaboration with practices, and a physician-friendly telehealth referral model. This approach includes free device trials and virtual coaching from experienced eSight Go users to help patients integrate the technology effectively and safely into their lives.

Mattern also noted the next steps for eSight and the eSight Go, highlighting scaling efforts such as clinical trials, peer education, and the expansion of a national sales force. Each of these advancements is aimed at broadening access to a device which could restore meaningful visual function and independence to patients traditionally underserved by conventional therapies.

Veeral Sheth, MD, is joined by the director of marketing of eSight to discuss the 5th generation eSight Go, a device to enhance central vision functions in patients with a variety of eye diseases.

Retinal Fluid and Visual Acuity After PDS Ranibizumab with Veeral Sheth, MD, MBA

2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

, Veeral Sheth, MD, MBA, director of clinical research at the University of Retina and Macula Associates and clinical assistant professor at the University of Illinois, presented a volumetric analysis of retinal fluids from the Archway phase 3 trial evaluating the Port Delivery System (PDS) with ranibizumab in patients with 

neovascular age-related macular degeneration

The post hoc analysis used a pre-trained deep learning model to segment subretinal and intraretinal fluid (SRF and IRF) on optical coherence tomography scans.

“What our model did was get rid of the noise, because with fluctuations, you get a lot of noise,” Sheth told 

. “And one of the key things is filtering out some of that noise. If you leave it to us just individually plot it out, it can be very labor-intensive, very cumbersome. This is where advancements in technology have really helped us. We can use these algorithms to get rid of the noise, and then we can really start looking at deviations in a slightly different way.”

In the phase 3 Archway trial, patients were randomized 3:2 between the PDS with ranibizumab 100 mg/mL, with established 24-week refills (PDS Q24W) and ranibizumab 0.5 mg intravitreal injection every 4 weeks (RBZ Q4W). Sheth’s study highlighted eyes with imaging data of quality adequate for volumetric analysis of retinal fluid. A variability metric robust to absent values and outliers was calculated for the central subfield thickness (CST), volume of SRF and IRF in the central subfield for each eye.

Sheth and colleagues found no significant difference in fluid fluctuation from baseline to week 96 across both treatment arms (PDS Q24W, RBZ Q4W, mean +/- [standard deviation] SD, CST (µm): 5.2 +/- 5.1, 4.9 +/- 6.5l; IRF (nL): 0.4 +/- 2.0, 0.5 +/- 2.6; SRF (nL): 2.1 +/- 3.8, 1.4 +/- 3.2, all 

When the team categorized by IRF fluctuation, best-corrected visual acuity (BCVA) was substantially higher (

 <.001) in eyes in the lowest quartile than in the highest (lowest vs highest IRF fluctuation quartile, mean +/-SD, BCVA (letters): 76 +/- 10.8, 68.0 +/- 17.0). However, when segmented by SRF fluctuation, median BCVA was not significantly different (

 >.05) in eyes in the lowest and highest quartile (lowest vs highest SRF fluctuation quartile, mean +/- SD, BCVA (letters): 72.9 +/- 14.3, 74.8 +/- 11.0).

Sheth and colleagues’ results showed that BCVA is significantly higher in eyes with less IRF fluctuation than with more.

“I think that really helps support some of the data, the building of a body of evidence that intraretinal fluid fluctuations or even residual intraretinal fluid really does matter, and has an impact on patients’ vision,” Sheth said. “I think we should look closely at intraretinal fluid in patients visit to visit and really look for treatments that address that variability or fluctuation in the intraretinal fluid.”

Sheth, V, et al. Volumetric analysis of retinal fluids in Archway phase 3 trial of the Port Delivery System with ranibizumab (PDS) in patients with nAMD. Abstract presented at Association for Research in Vision and Ophthalmology in Salt Lake City, UT, from May 3 - May 8, 2025.

A post hoc analysis of trial data reveals the effects of intraretinal fluid on best-corrected visual acuity in patients after port delivery system treatment for nAMD.

Veeral Sheth, MD, MBA, FASRS, FACS

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