12-month Phase 1 trial data from sustained drug delivery option for anti-VEGF therapy

EyePoint Pharmaceuticals released 12-month data from its Phase 1 DAVIO clinical trial evaluating EYP-1901, a sustained delivery (with Durasert) of anti-VEGF therapy for wet AMD. The company stated that this technology would provide the potential for treatment every 6 months. The Phase 1, 12-month data showed no ocular or systemic serious adverse events related to the drug. Stable BCVA, central subfield thickness on OCT, and late increased need for additional anti-VEGF therapy were confirmed by the data. Thirty-five percent of eyes did not need additional anti-VEGF therapy at 12 months compared to 53% who did not need additional therapy at 6 months. The treatment burden reduction was maintained at 74% at 12 months compared to 79% at 6 months. EyePoint will begin dosing patients for its 12-month, Phase 2 clinical trial of EYP-1901 in the third quarter of 2022.

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Phase 1b results for possible topical treatment of corneal injuries

Xequel Bio announced positive Phase 1b results for its iNexin (aCT1 ophthalmic solution) for treatment of patients with corneal injury related to dry eye disease. The study found that iNexin was safe and well tolerated at the dosing tested with early efficacy signs observed, according to the company. This study was single center, randomized, double masked, and vehicle controlled. There were no treatment-related serious adverse events or dose-limiting toxicities, alongside improvements in signs and symptoms of dry eye within 2 weeks of treatment. With this data, the company states that it will advance to designing a Phase 2 clinical trial.

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Long-term safety and efficacy reinforced with 2-year clinical trial data of AMD therapy

Genentech announced new 2-year data from two studies that evaluated its Vabysmo (faricimad-svoa) therapy in wet AMD. The data, according to the company, reinforces the safety and efficacy of this therapy for patients with wet AMD with fewer anti-VEGF injections required over time. A few of the findings included that more than 60% of patients receiving Vabysmo could be treated every 4 months with similar vision gains to those receiving aflibercept every 2 months, nearly 80% of people receiving Vabysmo could be treated every 3 months or longer, and fewer injections were given with Vabysmo (median 10) compared to patients on aflibercept (15 median injections).

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FDA accepts NDA for GA therapy

Apellis Pharmaceuticals announced that the FDA accepted and granted Priority Review for its New Drug Application (NDA) for intravitreal pegcetacoplan as a potential therapy for geographic atrophy (GA) secondary to AMD. According to the company’s press release, this investigational, targeted C3 therapy in Phase 2 and Phase 3 studies has demonstrated reduced GA lesion growth in a broad, heterogeneous population of more than 1,500 patients on monthly or bi-monthly treatment plans. The Prescription Drug User Fee Act date is set for November 26, 2022.

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NDA submitted for investigational dry eye treatment

Bausch + Lomb and Novaliq announced their NDA submission to the FDA for NOV03 (perfluorohexyloctane), seeking approval for this drug as a treatment for the signs and symptoms of dry eye associated with MGD. According to the press release, NOV03 is a water-free, single component, preservative-free eye drop that Bausch + Lomb has the exclusive license to commercialize and develop within the U.S. and Canada.

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Company completes guidance meeting with FDA for dry eye drug

Stuart Therapeutics completed a Type C Guidance meeting with the FDA for its development of ST-100, a dry eye disease drug candidate. ST-100 has completed a Phase 2 clinical trial, and with this info, the company asked the FDA for guidance on the company’s plan for moving this candidate forward, the press release stated. According to the company, the FDA accepted the plan for a Phase 3 trial of ST-100, approving its endpoints and also its overall development plan. The company plans on starting a Phase 3 clinical trial with ST-100 in early 2023. The company describes ST-100 as a topical formulation of a patented Collagen Mimetic Peptide Platform (PolyCol) that is designed to repair damaged corneal epithelial and sub-epithelial tissues and protect corneal nerve structures.

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Companies partner to conduct Phase 3 trials for possible NK treatment

With only one FDA approved treatment for neurotrophic keratitis in the U.S. (Oxervate, Dompe), RegeneRx Biopharmaceuticals and HLB Therapeutics are partnering to conduct two Phase 3 clinical trials, beginning this fall in the U.S. and Europe. The trials will evaluate RGN-259, a sterile, preservative-free topical therapy with thymosin beta 4 as its active ingredient. The drug is designed to reduce damage and heal various indications, including dry eye and neurotrophic keratopathy (NK), according to the company. Its Phase 3 trials will focus on NK patients, but the company stated that it plans to apply for a Special Protocol Assessment from the FDA for an additional dry eye trial in October 2022.

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Partnership to develop gene therapy

Avista Therapeutics, a new company launched from the University of Pittsburg Medical Center, announced that it has partnered with Roche to develop AAV-based gene therapies for ocular diseases. According to the company’s press release, its therapies will target gene delivery to individual retinal cell types, addressing the “underlying biology of the diseases.”

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ASCRS news and events

• ASCRS Summer Meeting: Register for the ASCRS Summer Meeting to get a “Taste of ASCRS”—its focused, anterior segment CME and in-person experience—August 19–21, in Nashville, Tennessee.
• Ophthalmology Quicksand Chronicles: Episode 3 of this popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD, is now online.

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Research highlights

• Research published in the American Journal of Ophthalmology sought to evaluate IOL calculation formulas in eyes with silicone oil. The authors of this retrospective, consecutive case series, which included 90 eyes matching inclusion criteria, stated that there is a refractive index change due to the silicone oil fill, making axial length measurement and effective lens position prediction less precise. However, they found that modern IOL calculation formula use can improve predictability, but they said that it is still not as good as that in unoperated eyes. The median absolute prediction error was lowest, according to the study, with the Barrett-Universal II formula, followed by Kane, Hill-RBF, Holladay 2, SRK/T, Holladay 1, Haigis, and Hoffer Q.
• Patient perceptions of immediately sequential bilateral cataract surgery (ISBCS) were evaluated in an investigator-led questionnaire (with open-ended and closed-ended questions). The authors wrote that while surgeon attitudes toward ISBCS are known, “little is known about patient perceptions.” The study included cataract patients in the NHS, within which only 0.5% undergo ISBCS. This study, published in the journal Eye, was completed by 183 patients, 43% of whom were aware that ISBCS exists, mostly informed by clinic staff. The study reported “just over a third would choose ISBCS if given the choice” and they were more likely to accept it if it was recommended. Convenience of ISBCS was the most common motivator and perceived risk of complications the most common barrier, according to the authors. The authors concluded that “significantly more NHS patients would be willing to undergo ISBCS if given the choice” and “the reluctance of surgeons to recommend ISBCS and patient misunderstandings regarding the recovery period may be limiting its uptake.”

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