• Bausch + Lomb and Modulight Corp. announced the FDA approved the ML6710i photodynamic laser for equivalent use with Bausch + Lomb’s VISUDYNE (verteporfin for injection) photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization, or the creation of abnormal choroidal blood vessels, due to AMD. ML6710i is a transportable ophthalmic laser that is controlled intuitively from an iPad mobile application. The laser’s beam shaping unit, which can be fit into all common slit lamps used for eye examinations, is formed into a circular, uniform spot to enable efficient treatment delivery of VISUDYNE. ML6710i is expected to be available for eye-care professionals during the first half of 2023.

• The FDA cleared HuidaGene’s investigational new drug application for the planned multi-national clinical trial of HG004, a novel ophthalmic injection for the treatment of patients suffering from RPE65 mutation-associated inherited retinal dystrophies. Based on the head-to-head preclinical comparison study of HG004 and adeno-associated virus serotype 2 (AAV2) at the same dose, the recovery of the retinal functions was increased by 67.6% (HG004) and 35.8% (AAV2 products) when compared to the wild-type mice in the RPE65 knockout murine model at Week 17 after a single injection. HG004 demonstrated better transduction efficiency of the retinal pigment epithelium compared with AAV2 and has the potential to lower the total vector doses. 

• HOYA Vision Care and NIDEK Co. announced a partnership that offers HOYA’s physician partners access to NIDEK’s optical products, services and instruments through local distributors.  The companies say the agreement enhances a physician’s ability to offer the latest in eye and vision examination equipment, visual comfort and performance to their patients. The agreement is effective immediately.

• Harrow issued a permanent, product-specific J-code for IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%, a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation containing no preservatives for ocular surface anesthesia. Under the Healthcare Common Procedure Coding System, the IHEEZO J‑code (J2403) will become effective April 1, 2023. 

• Clearside Biomedical announced positive results from the Extension Study of its OASIS Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector in neovascular AMD participants. These results include the final 6-month data from all participants in the Extension Study and augment the previously reported 3-month results and interim extension data. Suprachoroidal CLS-AX resulted in favorable safety data, durability and biologic effect over 6 months in the treatment-experienced anti-VEGF sub-responders. Additionally, 67% of study participants went at least 6 months without needing additional treatment, and a 77%-85% reduction in treatment burden was observed compared to the average monthly injections in the 6 months before CLS-AX administration. For more, see the study results from the Phase 1/2a trial here and the Extension Study results here.

• Frontera Therapeutics dosed the first patient in a clinical trial of its gene therapy product, FT-003, at the Ophthalmology Hospital of Tianjin Medical University in Tianjin, China. FT-003 is being studied for the treatment of neovascular or wet AMD and is Frontera’s second gene therapy product candidate to enter the clinic. FT-003 is designed as a one-time treatment. 

• Glaucoma Research Foundation (GRF) President and CEO Thomas M. Brunner announced Santen Pharmaceutical will receive GRF’s highest honor, the Catalyst Award, at the Glaucoma 360 Annual Gala in San Francisco. Santen is being recognized for its steadfast commitment to bringing innovation to the field of glaucoma.

• As part of February’s AMD and Low Vision Awareness Month, Prevent Blindness is offering free resources to the public to help educate and empower individuals, and their care partners, to make informed decisions about their vision and eye health. The “AMD Learning Center” and the free GuideMe app are designed for those who have been recently diagnosed with AMD — fact sheets and shareable graphics in English and Spanish are also available for free download. Additionally, resources are available for individuals with geographic atrophy in English and Spanish, including a downloadable fact sheet, a series of shareable social media graphics and a dedicated webpage. Also recently launched is the redesigned resource, “Living Well With Low Vision.”

• Dr. Reddy's Laboratories announced the launch of Dr. Reddy's Difluprednate Ophthalmic Emulsion 0.05%, a therapeutic generic equivalent to difluprednate ophthalmic emulsion 0.05% (Durezol, Novartis) in the US market, following the approval by the FDA. Durezol is a topical corticosteroid that is indicated for the treatment of inflammation and pain associated with ocular surgery and for the treatment of endogenous anterior uveitis.

• Dr. Rahil Chaudhary, an ophthalmologist and the managing director of Eye7 Eye Hospitals in New Delhi, set a Guinness World Record of 250 Contoura Vision (Alcon) laser eye surgery patients in one day, according to the Indian newspaper Yugmarg. The newspaper reports that Dr. Chaudhary also holds records for fastest laser eye surgery in India (1 minute 21 seconds), the most LASIK surgeries performed in India, the most ICL procedures performed in India and the most AI laser cataract surgeries performed in India.

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.