From Gene Therapy Trials to Ophthalmic Diagnostics — Robert Hoffmeister on Building Clinical VR

Before Robert Hoffmeister co founded Goodly Technologies, he spent several years developing regulated software for pharmaceutical industry and ended up selling his enterprise tote where he worked as director XR software engineering before  he went on  to develop,  for teh last two years on one of the most technically and regulatory demanding projects : building a Virtual Reality-based primary efficacy endpoint for a gene therapy company's Phase I clinical trials — and planning its role as the primary endpoint for Phase III registration studies.

The indication was Stargardt disease and Retinitis Pigmentosa — inherited retinal diseases for which no approved therapy currently exists. The gene therapy company I worked with is Munich-based and among the few in Europe advancing novel AAV-vector platforms into clinical ophthalmology.

FDA Engagement — The RDEA Program

This work was presented to the US Food and Drug Administration as part of the agency's Rare Disease Endpoint Advancement (RDEA) Pilot Program — established under PDUFA VII and the Food and Drug Omnibus Reform Act 2022. The program offers selected sponsors direct interaction with FDA reviewers to develop and validate novel efficacy endpoints for rare disease treatments.

The RDEA program is genuinely selective: the FDA accepts a maximum of three proposals per year globally. It exists because rare diseases often have no established regulatory precedent for how to measure treatment benefit — which is exactly the situation in inherited retinal diseases treated with gene therapy.

Participating in this process gave me a level of regulatory depth in Digital Health Technology (DHT) endpoints — usability requirements, measurement validity, cross-site reproducibility, FDA DHT guidance — that is directly foundational to what we are building with SeeCure.

 Why a VR Endpoint — and Why It Is Hard

In gene therapy trials for inherited retinal diseases, the central regulatory question is deceptively simple: did the therapy improve the patient's vision? Answering it robustly is not.

Standard visual acuity charts measure a narrow slice of visual function. Patients with Stargardt or RP experience vision loss across a much wider spectrum — peripheral field loss, contrast sensitivity, night vision, functional performance in real-world lighting. A primary endpoint that cannot capture these dimensions will not reflect the actual therapeutic benefit of the treatment.

VR allows us to create controlled, reproducible visual environments that measure functional vision in ways that paper charts simply cannot. The challenge is making that measurement clinically valid, reproducible across study sites, usable by the patient population, and — critically — acceptable to regulators.

The Connection to SeeCure

SeeCure is not a pivot from that work. It is the logical extension of it. The technology that enables a VR system to measure functional vision in a gene therapy trial is the same technology that enables a VR system to screen for glaucoma or macular degeneration in a care home — applied to a broader population, a less specialised operator, and a much larger addressable market.

The regulatory knowledge — what it takes to build a measurement tool that clinicians and regulators trust — is the most durable asset that experience created. That is what Goodly Technologies is built on.

Robert Hoffmeister is co-founder of Goodly Technologies GmbH and can be reached at robert.hoffmeister@goodly-technologies.com or via LinkedIn.