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

Welcome back to New Insight with Veeral Sheth, MD!

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 US Food and Drug Administration (FDA) approval of revakinagene taroretcel-lwey (ENCELTO), a groundbreaking encapsulated cell therapy for macular telangiectasia type 2 (MacTel).

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 ENCELTO.com 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.

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