NDA submitted to FDA for once-daily glaucoma drop

Visiox Pharma submitted an NDA to the FDA for its once-daily brimonidine drop, which if approved, would be the first once-a-day brimonidine treatment on the market for glaucoma. PDP-716 is designed with the company’s TearAct delivery technology for consistent sustained release. According to the company’s press release, the NDA submission is supported by data that demonstrated an IOP reduction for ocular hypertension and open-angle glaucoma with use of this drug.

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Positive Phase 3 data for novel preservative-free latanoprost delivery method

TearClear announced that primary and secondary endpoints were met in its Phase 3 pivotal trial for TC-002 (latanoprost), which is stored in conventional, multi-dose bottles but delivered onto the eye without preservatives. The company’s press release explained that while TC-002 contains the preservative benzalkonium chloride (BAK), which helps maintain sterility and drug stability but has been implicated for causing ocular surface issues, the BAK is removed as the drug is delivered to the eye. TearClear plans to file an IND with the FDA in the first quarter of 2023. It has already filed an IND with the FDA for TC-003 (brimonidine/timolol), which the company noted has been cleared for beginning a clinical trial. The company has plans for additional IND applications for other glaucoma medications as well.

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Phase 4 DME safety study reduces need for treatments

Alimera Sciences announced data from its Phase 4 safety study, which showed that patients with DME treated with ILUVIEN (fluocinolone acetonide intravitreal implant) needed fewer supplemental treatments. According to the press release, this implant, which delivers continuous therapy for up to 36 months, reduced the need for anti-VEGF, corticosteroid, and laser therapy. It reduced the total number of therapies administered to patients with DME by 46%, and 25% of eyes were supplemental treatment-free through the 36-month period, the press release stated. There was also an average increase in visual acuity among patients treated with ILUVIEN and a decrease in retinal thickness. This study was conducted at 41 U.S. sites and included 202 eyes of 159 patients with DME who had previously received corticosteroid treatment without a significant rise in IOP.

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New data from Phase 3 trial for investigational Acanthamoeba keratitis treatment

SIFI has issued new data from its Phase 3 study of AKANTIOR (polyhexanide) for treatment of Acanthamoeba keratitis. The new data compared the Phase 3 trial with a retrospective study, showing that when correcting for risk and other potentially confounding factors, the clinical resolution rate with AKANTIOR treatment was 86.7%, the company’s press release reported. The control arm (an unlicensed combination of PHMB and propamidine) achieved a resolution rate of 55% in a retrospective, real-world study that this data was compared to. The potential for patients to reach full visual acuity restoration with AKANTIOR was also higher (62%) compared to the findings in the real-world study with the control treatment (28%). According to the company, the original Phase 3 results were issued in 2021, showing a clinical resolution rate of 84.8% with the treatment. The control arm achieved resolution 88.5% of the time. The company plans to file an NDA with the FDA in 2023. It also stated that it expects approval in Europe by mid-2023.

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New findings on visual potential for adults with Leber congenital amaurosis

Two studies are reporting new findings that could impact the understanding of the visual potential for adults with Leber congenital amaurosis (LCA). One, using rodent models, found that synthetic retinoids (which are already used to restore vision in children with LCA) could restore central visual pathway signaling in adults. The researchers from the University of California, Irvine, said in a press release that this is a paradigm shift that “could aid in the development of retinoid therapies to more completely rescue the central visual pathway of adults with this condition.” A different study from researchers at the Scheie Eye Institute at the University of Pennsylvania reported on a gene therapy that was used to treat adults with LCA caused by mutations in the GUCY2D gene. The university’s press release stated that patients’ treated eyes showed “large increases … of visual functions mediated by rod-type photoreceptor cells.” The press release called out two patients in particular who received higher doses of the gene therapy. These patients were noted to have severe rod-based visual deficits with greatly impaired visual function in daylight and blindness at night. After gene therapy was administered to one eye in each of these patients, researchers observed that the treated eye “became thousands of times more light sensitive in low-light conditions, substantially correcting the original visual deficits,” according to the press release.

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ASCRS news and events

• 2023 ASCRS Annual Meeting: The call for abstract submissions for the 2023 ASCRS Annual Meeting closes today, October 14.
• National Sight Week: This week is the ASCRS Foundation’s National Sight Week (October 9–15).
• EyeWorld magazine: Find the latest quarterly issue of EyeWorld with a focus on “Back to basics” online now. Also take a look at recent EyeWorld Online Exclusives.

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Research highlights

• Ultra-thin DSAEK vs. DMEK for treatment of Fuchs and bullous keratopathy was evaluated in a systematic review and meta-analysis. The paper published in the American Journal of Ophthalmology included seven studies (out of 163 reviewed) that met inclusion and exclusion criteria. The authors found that BCVA improvement was higher in ultra-thin DSAEK compared to conventional DSAEK, but it was even better with DMEK. Complication rates were comparable, but the rebubbling rate after DMEK was higher.
• Initial experience with topical pegylated interferon alpha 2a (pegIFN-α-2a) for ocular surface squamous neoplasia (OSSN) was reported in a retrospective medical record review of eight eyes from eight patients. These patients were diagnosed with non-invasive OSSN, and pegIFN-α-2a, 20 μg/mL, was prescribed for application 4 times a day for at least 3 months. The treatment was well tolerated and did not result in discomfort or adverse side effects, the paper reported. Lesion size was reduced with complete resolution of lesions in all case. This research is published in the journal Cornea.

 

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Product news

• Santen announced Health Canada approval for Cationorm Plus artificial tears for dry eye and ocular allergy symptoms.

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