• Aldeyra Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for topical ocular reproxalap, an investigational new drug (IND) candidate for the treatment of signs and symptoms of dry eye disease (DED). If approved, reproxalap would be the first marketed reactive aldehyde species (RASP) modulator, representing a novel, systems-based pharmacology involving a family of small molecule targets that affect a broad array of protein mediators. In addition to DED, reproxalap is in late-stage development for allergic conjunctivitis.

• Kala Pharmaceuticals announced the submission of an IND application to the FDA for KPI-012 for the treatment of persistent corneal epithelial defect (PCED). Subject to acceptance of the IND by the FDA, Kala remains on track to initiate a Phase 2b clinical trial of KPI-012 for PCED in the fourth quarter of 2022. Topline safety and efficacy data from the trial is expected in the first quarter of 2024.

• STAAR Surgical opened the first company-operated EVO Experience Center, located at STAAR’s corporate headquarters in Lake Forest, Calif. The center is equipped with advanced visualization and communications technology, allowing for in-person and virtual training, medical education and practice development programs. The center features a surgical simulation room that includes STAAR’s Online Calculation & Ordering System, an OCULUS Pentacam AXL Wave, 3D visualization for EVO lens loading and delivery and a Collamer chamber that demonstrates the tensile mechanical properties of STAAR’s proprietary Collamer material.

• Lighthouse Guild, a not-for-profit vision and health-care organization, and Bionic Sight are entering into a partnership. Bionic Sight’s technology focuses on restoring sight to patients with advanced stage blindness due to retinal degenerative diseases, such as retinitis pigmentosa. The technology is based on discoveries by researcher and developer Sheila Nirenberg, PhD, the founder of Bionic Sight who unraveled the neural code of the retina. This technology will be used to develop a new approach for treating blindness.

• RetinAI Medical AG launched Discovery CORE with artificial intelligence (AI) for retinal fluid and layer segmentation. Discovery CORE and its AI models have been designed to accelerate data analysis and help clinical and academic researchers collaborate more efficiently in real time with their peers on medical and imaging datasets. The software measures retinal fluid volumes and layer thickness across OCT datasets automatically and integrates annotation tools and electronic case report forms, which enable new data insights to be collected across peer networks, keeping the information digitized, centralized and secure.

• Opus Genetics announced the FDA cleared its IND application for a Phase 1/2, first-in-human clinical trial of OPGx-001 in patients with Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene. OPGx-001 is an adeno-associated virus 8 vector to precisely deliver a functional LCA5 gene to retinal photoreceptors. There are no approved treatments for individuals with LCA5-related vision loss. The Phase 1/2 trial will evaluate the subretinal delivery of OPGx-001 in nine adult patients with LCA5. The objective of the trial is to evaluate safety and potential benefit.

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.