Update on safety review of geographic atrophy drug

Apellis Pharmaceuticals has provided an update on its review of rare safety events that were recently reported with its geographic atrophy drug, SYFOVRE (pegcetacoplan injection). In July, an alert from the American Society of Retina Specialists (ASRS) was emailed to its members informing them of reported occlusive and non-occlusive retinal vasculitis events after treatment with SYFOVRE, the first and only drug for geographic atrophy, approved by the FDA in February. In its update on its review of seven events reported after real-world treatment with SYFOVRE (more than 68,000 vials have been distributed to date), Apellis stated that there is no indication that the drug product or any manufacturing issues led to these events. The company’s press release also stated that there were no new safety findings in the clinical trial data after a secondary review (there were zero events reported in the clinical trials that followed more than 23,000 injections to date). The company further stated that there were no identified manufacturing-related issues impacting product quality, no quality or contaminants discovered, no association with a single manufacturing lot, and no indications of drug-related immunogenicity in clinical trial data. The company stated that it is continuing to work closely with the retina community in investigating these cases. In a separate press release, the company recently reported observing increased treatment effects with the drug between 24–30 months in a long-term extension study. Safety remained consistent with previously reported clinical trial data.

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IND application accepted by FDA for wet AMD gene therapy

Skyline Therapeutics announced that the FDA cleared its IND application for its one-time intravitreal gene therapy to treat neovascular/wet AMD. With this application acceptance, the company plans to begin a Phase 1/2a clinical trial for SKG0106. According to the company’s press release, SKG0106 is a “distinctively designed recombinant adeno-associated virus (rAAV)-mediated gene therapy for ocular disease. It encompasses a proprietary novel AAV capsid and a uniquely configured transgene genome encoding anti-VEGF protein.” Preclinical studies, according to the company, showed that the gene therapy could inhibit intraocular neovascularization with durability and a favorable safety profile.

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Phase 2 trial planned for investigational neuropathic corneal pain treatment

OKYO Pharma announced that it plans to begin a Phase 2 open-label trial for its investigational OK-101 therapy, assessing its safety and efficacy in patients with neuropathic corneal pain. This study, which plans to enroll 40 patients and is expected to begin in the fourth quarter of 2023, is the second Phase 2 trial for OK-101. The first began dosing patients in June of this year and is intended to assess safety and efficacy of the therapy for dry eye disease. OK-101 is described by the company as a “lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, which is typically found on immune cells of the eye responsible for the inflammatory response.”

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Interim Phase 2 data for sustained wet AMD treatment

EyePoint Pharmaceuticals announced interim masked safety data from its Phase 2 clinical trial of EYP-1901, which the company explained is a therapy that has the potential to provide sustained maintenance treatment to patients with wet AMD. According to the company’s press release, there continues to be no serious adverse ocular events and no drug-related systemic serious adverse events in the study. The therapy is intended to preserve vision and reduce treatment burden of frequent injections typically required for wet AMD. The company also reported baseline characteristics for this trial, comparing them to its Phase 1 trial; patients’ mean best BCVA is better in the Phase 2 trial (74 letters compared to 69 letters in Phase 1) and mean age in Phase 2 is 76 years old, compared to 77.4 years in Phase 1. Topline results from the Phase 2 trial are expected in December.

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ASCRS news and events

• ASCRS Summer Meeting: Save your seat at the ASCRS Summer Meeting in Nashville, Tennessee, August 11–13.
• ASCRS Podcast: The latest episode of Ophthalmology Quicksand Chronicles—Eureka Moments, featuring guest Steven Safran, MD, is online now.
• ASCRS Annual Meeting: The call for submissions for the 2024 ASCRS Annual Meeting is going on now through October 9. Find submission details here.

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Research highlights

• The influence of certain ocular parameters on accuracy of newer-generation IOL power calculation formulas were evaluated in a retrospective, single-center case series study published in the Journal of Cataract & Refractive Surgery. The study included Barrett Universal II, Castrop, Emmetropia Verifying Optical 2.0, Hill RBF 3.0, Kane, and PEARL-DGS formulas with and without optional biometric parameters. In 251 eyes from 251 patients, the researchers found that excluding lens thickness (an optional parameter) led to a statistically significant difference in absolute prediction error in several formulas. Not including horizontal corneal diameter did not affect absolute prediction error. The authors concluded that “when using multivariate formulas with an A-constant, including certain optional parameters is vital for optimal refractive results.”
• DMEK, DSAEK, and DSAEK with cataract surgery for patients with Fuchs were compared in a register-based study with propensity score matching. The study, published in the journal Ophthalmology, included 1,677 cases from the Swedish Corneal Transplant Register; procedures were performed between 2012 and 2019 and patients had 2 years of follow-up. The investigators wrote that “three comparable groups (DMEK, DSAEK, phaco/DSAEK) with 216 cases in each group were generated with propensity score matching based on preoperative visual acuity, age, sex, year of surgery and preoperative risk factors such as inflammation, vascularization, and glaucoma.” The authors found that visual acuity improved in most cases (90%) across all surgical options, but DMEK and phaco/DSAEK resulted in better visual acuity at 2 years postop. Phaco/DSAEK had a better graft survival rate. The authors wrote that there were strengths and weaknesses in each option, suggesting that procedures should be individualized.

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Product news

• The transfer of the NDA for VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) to Harrow is complete (commercial rights were purchased by the company in January). VIGAMOX is now available through Harrow.
• Verséa Ophthalmics entered into an exclusive commercialization agreement with Celularity to distribute Celularity’s BIOVANCE and BIOVANCE 3L Ocular products in the U.S.

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