Industry updates from Floretina ICOOR 2024
The annual meeting brought fourth announcements and insights from companies in the retina care space
Ophthalmic companies brought information from recent and ongoing trials to Floretina ICOOR 2024. Image credit: ©GVictoria – stock.adobe.com
One of the final retina meetings of 2024 brought clinicians and industry together in Florence, Italy. This year’s Floretina meeting and International Congress on OCT Angiography, En Face OCT and Advances in OCT (ICOOR) began on 5 December and concludes on the afternoon of Sunday, 8 December. According to meeting organisers, over 300 speakers and 2,900 attendees were expected for this year’s meeting, and the congress received support from 59 sponsoring partners.
Prior to and during the meeting, companies from the retina care industry released information about new data and presentations featured at Floretina ICOOR 2024. Find these insights and announcements compiled below.
This page may be updated as information is released.
7 December, 2024
Alkeus
Alkeus Pharmaceuticals, Inc. shared results from the Tolerability and Effects of ALK-001 on Stargardt diseasE (TEASE) studies. The four independent TEASE studies address use of oral gildeuretinol (ALK-001) in Stargardt disease.1 In the TEASE-1 study, gildeuretinol was well-tolerated and met its prespecified primary efficacy endpoint. Study findings demonstrated a 21.6% reduction in the growth rate of retinal atrophic lesions area (square root) (P < .001), and a 29.5% reduction for untransformed areas of retinal atrophic lesions against untreated patients.
The ongoing TEASE-2 trial is expected to read out topline data in 2025. The other TEASE trials are both open-label studies; TEASE-3 addresses patients with genetically confirmed, early-stage Stargardt disease who have not yet begun experiencing symptoms of vision loss, and TEASE-4 is an open-label extension study.
Annexon
Annexon shared key details from the Phase 2 ARCHER trial of its complement therapy ANX007. The trial evaluates ANX007 for prevention of visual acuity loss and preservation of photoreceptors in patients with dry age-related macular degeneration (AMD) and geographic atrophy (GA). In this presentation, Annexon noted, findings included patients with less advanced disease.2
As reported previously by Ophthalmology Times, ANX007, administered intravitreally, is a non-pegylated antigen-binding fragment designed to block C1q locally in the eye. In the ongoing trials, ANX007 has demonstrated significant vision protection in standard and low light conditions. The research findings also indicate “significant preservation of photoreceptors in the fovea region critical for visual acuity,” the company said.
Annexon is currently enrolling patients for a pivotal Phase 3 ARCHER II trial in GA, and expects to share data from that phase during the second half of 2026.
Opthea
Opthea Limited announced that its lead product candidate sozinibercept was featured in an oral presentation on emerging therapies for wet AMD at the meeting.3 The presentation by Adnan Tufail, MBBS, MD, FRCOphth, was titled "Beyond VEGF-A inhibition: Will blocking VEGF-C and VEGF-D lead to better outcomes?" Currently, sozinibercept is being evaluated in two pivotal Phase 3 clinical trials, COAST (NCT04757636) and ShORe (NCT04757610). Sozinibercept is being investigated for use in combination with anti-VEGF-A therapies to improve overall efficacy and enhance vision acuity gains compared to standard-of-care anti-VEGF-A agents alone.
9 December, 2024
AAVantgarde Bio
AAVantgarde Bio presented preliminary safety data4 from the LUCE-1 trial, a Phase 1/2 open label trial of AAVB-081. The gene therapy platform delivers MYO7A protein to patients with retinitis pigmentosa (RP) related to Usher Syndrome Type 1B (USH1B). Preliminary findings focused on two patients with RP and USH1B in a low-dose cohort. In the safety findings for both subjects, best corrected visual acuity returned to pre-treatment level within 2 weeks. Francesca Simonelli, MD, head of the ophthalmology unit at the University Hospital of Campania Luigi Vanvitelli in Naples, Italy, serves as principal investigator and supervised the subretinal gene therapy procedure. "These preliminary safety results are very encouraging, and we are progressing with the dose escalation in this study," Prof Simonelli said in a press release. "AAVB-081 shows a favourable safety profile, with no significant immune response and has potential for visual improvement, that I hope will help greatly improving the quality of life of these patients."
