Two-year results from Phase 3 study for GA therapy

Apellis Pharmaceuticals announced the 24-month results from its two Phase 3 studies evaluating the effect of one-time administration of pegcetacoplan on geographic atrophy (GA). According to the company’s press release, this treatment’s effect was accelerated between 18 and 24 months, showing a reduction of GA lesion growth compared to sham. More specifically, the DERBY trial showed a 19% monthly reduction in lesion growth and OAKS trial 22% monthly reduction. During months 18–24, lesion reduction was 36% and 24% in the DERBY and OAKS trial, respectively. With these results and a PDUFA date set for November 26, the company stated that pegcetacoplan, a targeted C3 therapy, could be the first treatment for GA within the U.S., if approved.

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BLA resubmission for bevacizumab

Outlook Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for bevacizumab (LYTENAVA) for treatment of wet AMD, providing additional information at the FDA’s request, according to the company’s press release. This product, if approved, would “provide retina patients with an on-label treatment option,” the company’s CEO said in a statement. Potential approval would be expected in 2023, and Outlook Therapeutics noted in its press release that it is moving forward with plans for a commercial launch.

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Strategic licensing for pharmacologic treatment for keratoconus

iVeena Delivery Systems announced a strategic licensing agreement with Glaukos to develop and commercialize IVMED-80, a pharmacologic treatment for keratoconus. According to the company’s press release, IVMED-80 is a topical eye drop that currently has an orphan drug designation. It upregulates lysyl oxidase to induce pharmacologic crosslinking within the cornea. A 6-month Phase 1/2a study found that this therapy had a significant reduction in baseline-adjusted Kmax of 1 D relative to placebo. According to the press release, Glaukos paid $10 million upfront and will assume all costs associated with the development and regulatory activities of IVMED-80 going forward. The terms of the agreement also include the potential for milestone payments and royalties to iVeena.

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Study: Gene therapy restores some cone function to otherwise colorblind children

Research from the University College London (UCL) published in the journal Brain describes an academic study running alongside a Phase 1/2 clinical trial for children with achromatopsia. According to a university news article about the research, these patients’ cone cells do not send signals to the brain, so researchers are trying to activate these otherwise dormant cells. There were 4 people ages 10–15 years old included in the studies, which took place at UCL and Moorfields Eye Hospital and involved MeiraGtx-Janssen Pharmaceuticals. The studies targeted two different genes involved in achromatopsia. The university’s article stated that two of the patients showed evidence of cone-mediated signals in the brain’s visual cortex from the treated eye 6–14 months after treatment, while no signals were detected prior to treatment. The signals were also similar to those of normally sighted study participants. The results are still being analyzed and will inform future studies.

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ASCRS news and events

• ASCRS Annual Meeting: The call for abstract submissions for the 2023 ASCRS Annual Meeting is open now through October 14.
• ASCRS Summer Meeting recap: Watch video interviews with faculty and attendees here.
• EyeWorld magazine: Articles from the September issue of EyeWorld are online, and more will be released in the coming weeks. To flip through the full issue, click here.

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Research highlights

• While observational studies during the height of the COVID-19 pandemic noted that wearing glasses might protect against transmissions of the virus, a cohort study’s findings on the topic published in the journal JAMA Ophthalmology are inconclusive. The study included 2,120 individuals, working in the first wave of the pandemic in Denmark and Sweden. Personal protective equipment was not recommended for the general population at the time. The authors found that while wearing glasses in Sweden seemed to result in a lower prevalence of COVID-19 infection among the workers in a rescue corps (8.1% vs. 12.6% of glasses wearers and non-glasses wearers, respectively), it did not have this effect in Denmark among rescue corps workers (2.5% vs. 2.2%). After the authors adjusted for confounding factors, the reduced COVID-19 infection among glasses wearers in Sweden was no longer prevalent.
• Long-term clinical outcomes and success rates of Bowman layer inlay transplantation for treatment of progressive keratoconus are reported in a study published in Cornea. The research included 35 eyes (29 patients) followed for up to 8 years. The mean logMAR for best contact lens-corrected visual acuity for the whole study set and two subgroups (group 1: preop Kmax >69 D [n=26 eyes]; group 2: preop Kmax <69 D [n=9 eyes]) did not change from the preop baseline. But best spectacle-corrected visual acuity improved in group 1. Group 1 showed an average Kmax reduction of 7 D in the first month postop, but no further changes were observed within the up to 8 years of follow-up. The authors reported no significant changes in group 2. Progression of keratoconus continued in 4 eyes, 3 in group one and 1 in group 2. The authors concluded that Bowman layer inlay transplantation stabilized keratoconus in most eyes, preserving contact lens tolerance for up to 8 years.

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