FDA approves presbyopia drop

Orasis Pharmaceuticals announced FDA approval of its drop, QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4%, for temporary treatment of presbyopia. This is the second FDA approved drop for this indication (the first being Vuity, Allergan). According to the Orasis press release, QLOSI, which is expected to be commercially available in the first half of 2024, can be used up to twice a day, if needed. The company reported that it demonstrated efficacy within 20 minutes of administration with an effect lasting for up to 8 hours. According to the company, this preservative-free formulation improves near vision (a 3 or more line gain) without impacting distance or night vision. The most common treatment-related adverse events were headache and instillation site pain, 6.8% and 5.8%, respectively; 1.3% reported moderate treatment-related adverse events.

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FDA approves expanded capabilities on anterior segment diagnostic platform

Heidelberg Engineering announced FDA clearance of additional capabilities on its ANTERION platform, which it described as an anterior segment diagnostic and practice workflow platform that combines biometry, IOL power calculation with corneal topography and tomography, anterior chamber metrics, and high-resolution imaging. The company reported that ANTERION received FDA approval in 2021, but more recently the FDA approved additional capabilities with the technology’s Cornea App, Metrics App, and Cataract App.

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Phase 4 data presented for dry eye disease drug

Sun Pharma announced the presentation of a Phase 4 investigator-led study that evaluated symptom improvement after CEQUA (cyclosporine ophthalmic solution) 0.09% use in patients whose dry eye disease was “uncontrolled” after at least 3 months of Restasis (cyclosporine ophthalmic emulsion, Allergan) 0.05% use. According to the data, CEQUA improved corneal fluorescein staining (CFS) after 12 weeks of twice-daily administration; improvement started at week 4. The study included 123 patients (110 of whom were female). Mean CFS score at baseline was 5.7; it improved significantly to 4.0 at week 4, 2.9 at week 8, and 2.7 at week 12. Symptom assessments also improved significantly. The press release reported no new safety signals, though 43.3% of patients reported a treatment-emergent adverse event. Most adverse events were mild (73.8%), and most common was instillation site irritation and site pain.

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Extension study for investigational wet AMD treatment demonstrates safety, efficacy

Clearside Biomedical announced presentation of results from its 3-month extension study of its original Phase 1/2a 3-month clinical trial of CLS-AX (axitinib injectable suspension) for neovascular AMD (wet AMD). The original 3-month trial involved a single dose of CLS-AX, administered via suprachoroidal injection. The extension study included “sub-responders with active disease at screening.” According to the company, the patients included in the trial were “heavily anti-VEGF treatment experienced with active disease at screening.” Among all cohorts, which received different doses of CLS-AX, there were no serious adverse or treatment-emergent adverse events. The cohorts that received higher doses and were involved through the extension study (for a total of 6 months) saw a 77–85% reduction in treatment burden compared to average monthly injections prior to the study. CLS-AX showed “signs of a biologic effect with stable mean BCVA and stable mean CST” out to 6 months, the press release noted. A Phase 2b clinical trial is enrolling and on target for enrollment completion by the third quarter of 2024.

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Reports suggest reproxalap NDA might not be approved

According to a report from the Securities and Exchange Commission (SEC), Aldeyra Therapeutics announced that it received minutes from “a late-cycle review meeting with the [FDA]” for its NDA for reproxalap for the treatment of signs and symptoms of dry eye disease. According to the SEC report, the FDA stated that the company “does not appear … [to] have data to support the clinical relevance of the ocular signs to support your dry eye indication.” Aldeyra, the SEC continued, submitted responses to the FDA, but the FDA has indicated that additional clinical trial data is needed. The SEC reported that the FDA “may not be in a position to approve the NDA for reproxalap” by the PDUFA target action date of November 23.

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Companies partner to develop gene therapy

SpliceBio and Spark Therapeutics announced their exclusive collaboration and licensing agreement to develop a gene therapy for an undisclosed inherited retinal disease, using SpliceBio’s Protein Splicing platform.

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ASCRS news and events

• ASCRS Live Webinar: “Complex Presbyopia IOLs,” a live educational event, will take place Tuesday, October 24 at 9:00 p.m. ET. Register now for this webinar.
• A Taste of ASCRS: This nine-section CME program recorded from the 2023 ASCRS Summer Meeting is now available on demand. Learn more about the program.

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Research highlights

• ASCRS published a clinical advisory on the optimal dosing of intracameral moxifloxacin based on current evidence. The review, published in the Journal of Cataract & Refractive Surgery, described two concentrations: ones that are 0.5% (5 mg/ML) as the topical drop Vigamox (Novartis) or from compounding pharmacies and 0.1% (1 mg/ML) in a compounded form. The advisory provided recommended dosing regimens and noted that the “correct dosing of IC moxifloxacin is important to maximize bactericidal efficacy and minimize ocular toxicity.”
• A retrospective cohort study published in the journal Ophthalmology assessed the risk factors for worse visual acuity outcomes after IOL exchange, as well as common postop complications. Using data from the IRIS Registry, 46,063 procedures (41,925 unique patients) were included. Visual acuity improved from a mean of 20/70 preop to a mean of 20/40 at 1 year postop. The authors reported that of the eyes that had both preop and postop visual acuity at 1 year reported, 60.5% had a visual acuity of 20/40 or better at 1 year. Having a worse than 20/40 visual acuity at 1 year postop was associated with older age, a higher baseline visual acuity, ethnicities of Black, African American, Hispanic, or Asian, being on Medicaid (vs. private insurance), smoking, and having a vitrectomy. The most common complication after IOL exchange was epiretinal membrane.

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Product news

• Bausch + Lomb launched the enVista Aspire monofocal and toric IOLs with Intermediate Optimized optics, which the company’s press release stated is “designed for a broader depth of focus” on a “glistening-free optic material.”

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