• Orasis Pharmaceuticals announced today the FDA approved QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is a prescription eyedrop that can be used daily, or as needed, up to twice per day. QLOSI demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision, the company says. QLOSI is a preservative-free formulation of pilocarpine, an established eye-care therapeutic, designed to achieve an optimal balance between efficacy, safety and comfort. The FDA approval is based on results from the Phase 3 NEAR-1 and NEAR-2 clinical trials. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity and no loss of 1-line or more in distance visual acuity. QLOSI is expected to be commercially available in the United States in the first half of 2024.

• Bausch + Lomb announced the launch of the enVista Aspire monofocal and toric IOLs with Intermediate Optimized optics in the United States. enVista Aspire combines novel optics, which are designed for a broader depth of focus, with the benefits of the enVista platform to address the patient’s vision needs in today’s digital world. enVista Aspire optics allow for a range of vision beyond one focal point. Like enVista MX60E, enVista Aspire offers a glistening-free optic material and controlled, efficient unfolding through Bausch + Lomb’s proprietary StableFlex Technology, which aids optic recovery. enVista Aspire Toric IOLs provide an option for treatment of astigmatism during cataract surgery. The AccuSet haptic design allows for rotational stability, an important attribute for toric lenses.

• Heidelberg Engineering announced FDA clearance of its ANTERION platform that combines biometry, IOL power calculation with corneal topography and tomography, anterior chamber metrics, and high-resolution imaging. Additional proprietary features such as patented eye tracking and composite imaging technologies help deliver sharp image quality, allowing physicians to perform anterior segment examinations and acquire measurements via high-resolution swept-source OCT images. The platform features an Imaging App that focuses on the high-resolution visualization of the anterior segment and delivers OCT images. ANTERION's functionality also features apps designed to meet a variety of clinical needs. The Cataract App combines key measurements for cataract surgery planning, including integrated monofocal and toric IOL calculators; the Cornea App provides a comprehensive set of corneal measurements for the evaluation of a patient’s individual corneal geometry; and the Metrics App features swept-source OCT images with the anterior chamber displayed in a radial view.

• Aviceda Therapeutics reported positive data of its lead ophthalmic clinical asset, AVD-104, a novel glycomimetic nanoparticle. The Phase 2/3 SIGLEC trial is currently underway evaluating patients with geographic atrophy (GA) secondary to AMD. Updated data showed continued safety of AVD-104, with no drug-related adverse events or serious adverse events at 3 months in cohorts 1 and 2, 2 months in cohort 3, and 1 month in cohort 4. No evidence of any significant dose-limiting toxicity has been observed, locally or systemically. Notably, no drug-related ocular inflammation, retinal vasculitis, choroidal neovascularization, infection or optic nerve abnormalities were observed in any eyes. In addition, AVD-104 demonstrated an excellent safety profile in an ongoing 9-month repeat-dose toxicology study in non-human primates, with no significant safety signals observed with the three tested doses. For more, see the study results here.

• Baxter International announced the launch of digital image capture capability for eye exams using its existing Welch AllynPanOptic Plus Ophthalmoscope. The iExaminer Pro System is designed to help advance health-care professionals’ ability to examine and diagnose the eye health of patients. The PanOptic Plus Ophthalmoscope with iExaminer Pro System adds the ability to connect a smart device to capture images for further examination and enables clinicians to move quickly from an optical exam to adding digital image capture. When used with the iExaminer Pro App, clinicians can securely save and share eye images for tracking and trending and initiate more informed consultations with specialists. The new offering is now available in the United States. 

• SpliceBio announced the signing of an exclusive collaboration and licensing agreement with Spark Therapeutics to utilize SpliceBio's proprietary Protein Splicing platform to develop a gene therapy for an undisclosed inherited retinal disease. Under the terms of the agreement, SpliceBio and Spark will conduct a research collaboration utilizing SpliceBio's proprietary Protein Splicing platform, which offers the potential to address diseases that currently cannot be treated with gene therapies because the necessary gene is too large to be delivered by adeno-associated virus vectors. Spark will have exclusive worldwide rights to develop, manufacture and commercialize a gene therapy arising from this research collaboration targeting an undisclosed inherited retinal disease. SpliceBio will be eligible to receive upfront, opt-in and milestone payments up to $216 million and royalties on net sales.

• The FDA noted “substantive review issues” in connection with the new drug application for Aldeyra Therapeutics’ reproxalap for the treatment of the signs and symptoms of dry eye disease. In a Securities and Exchange Commission filing on Monday, Aldeyra noted minutes from a late-cycle review meeting in which the FDA stated “[i]t does not appear that you have data to support the clinical relevance of the ocular signs to support your dry eye indication.” In subsequent communications between Aldeyra and the FDA, Aldeyra submitted responses to the FDA that Aldeyra believes to be sufficient to mitigate the identified issues, but the FDA, according to the SEC filings, “has not directly opined on the sufficiency of the information submitted, has no legal obligation to review the information submitted by Aldeyra, and has indicated that Aldeyra needs to conduct an additional clinical trial to satisfy efficacy requirements.” Aldeyra said in the SEC filing that its ability to generate revenue will depend on the successful development, regulatory approval and commercialization of reproxalap. “If Aldeyra is unable to successfully obtain FDA approval, or FDA approval is delayed or limited, Aldeyra’s ability to generate revenue will be significantly delayed,” the company noted.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.