WHAT’S NEW IN CORNEA

Cellusion Inc. and Minaris Regenerative Medicine announced Letter of Intent of the manufacturing of CLS001 for a corneal endothelial cell regenerative therapy in the United States. Cellusion and Minaris will develop the manufacturing process of Cellusion’s leading program, CLS001, a novel regenerative medicine for bullous keratopathy treatment.

Eversight announced the availability of Descemet’s membrane endothelial keratoplasty (DMEK) tissue preloaded in EndoGlide. Preloaded DMEK EndoGlide utilizes an endothelium-in or trifold loading method. Using an anterior chamber maintainer for infusion, the graft is pulled into the eye with specialized forceps through a 2.65-mm incision.

Glaukos Corp. commenced subject enrollment in a second Phase 3 confirmatory pivotal trial for Epioxa (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus. Glaukos is targeting enrollment completion by the end of 2023.

HCP Cureblindness acquired the SightLife International Program. SightLife International and HCP Cureblindness will look for opportunities to partner with SightLife US and Lions Eye Institute for Transplant and Research to support technical training for eye bank personnel and surgeons globally, as well as provide corneal tissue to areas where eye bank development is not feasible.

The FDA granted Fast Track designation for Kala Pharmaceuticals’ human mesenchymal stem cell secretome therapy (KPI-012) for the treatment of persistent corneal epithelial defect (PCED).

Kuria Therapeutics completed a pre-IND interaction with the FDA and received positive feedback on its development program for KTX-1161 for corneal endothelial disease. KTX-1161 is a topical ophthalmic solution formulation of SCO-116. Kuria is developing KTX-1161 to treat patients with diseases of the corneal endothelium.

Tarsus Pharmaceuticals’ new drug application was accepted by the FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis, with a Prescription Drug User Fee Act target action date of Aug. 25, 2023.

WaveFront Dynamics announced the commercial launch of its aberrometry measurement system, the WaveDyn Vision Analyzer. The system captures a video of the eye’s dynamic optical system over time rather than producing a single measurement.

IN THE NEWS

Johnson & Johnson Vision’s ELITA Femtosecond Laser received FDA 510(k) clearance for the creation of LASIK flaps. ELITA provides low energy per pulse, fast laser repetition rate and small spot size (1 µm), smooth stromal bed and sub-micron precision.

The FDA approved Eyenovia Inc.’s Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. This represents the first approved fixed-dose combination of tropicamide and phenylephrine in the United States.

Alcon’s open-platform NGENUITY 1.5 Digital 3D Visualization System is now available in the United States. NGENUITY 1.5 provides sharp visualization with usability, color, contrast and magnification enhancements. It also offers connectivity to ARGOS Biometer diagnostic images.

The FDA approved the CT LUCIA 621P Monofocal aspheric, single-piece C-loop IOL from ZEISS Medical Technology. The IOL features the ZEISS Optic Asphericity Concept, designed to compensate for a range of spherical aberrations and optimize visual outcomes in the event of potential decentration/lens misalignments.

Centricity Vision received 510(k) clearance from the FDA for the ZEPTOLink IOL Positioning System. The platform integrates the ZEPTO precision pulse capsulotomy technology with any phaco system to streamline cataract surgery. ZEPTOLink uses suction and irrigation provided by the phaco system.

Norlase received FDA 510(k) clearance for the ECHO Green Pattern Laser photocoagulator, a portable scanning laser photocoagulator utilizing microelectromechanical systems technology. The laser and scanner are completely integrated into a single delivery device that attaches to compatible slit lamps.

Lumibird Medical launched two additional variants within its Nd:YAG/SLT laser range: the Ultra Q Reflex Neo and Tango Neo. A fully integrated Q-switched Nd:YAG laser for anterior-segment YAG and glaucoma indications, Ultra Q Reflex Neo features second-generation Reflex technology with True Coaxial Illumination. Tango Neo has an improved general user interface.

Nova Eye Medical was granted FDA 510(k) clearance for its iTrack Advance canaloplasty device. iTrack Advance has been cleared for microcatheterization and viscodilation to reduce IOP in adult patients with primary open-angle glaucoma.

Bausch + Lomb and Heidelberg Engineering introduced the SeeLuma Fully Digital Surgical Visualization Platform. Bausch + Lomb also announced the US launch of the StableVisc device and the TotalVisc Viscoelastic System.

Iridex Corp. announced the full US market launch of the next-generation Iridex PASCAL laser with MicroPulse. The platform combines fast and precise pattern scanning capabilities in a smaller integrated laser platform and includes three tissue-sparing technology options.

NIDEK launched NT-1/1e non-contact tonometer models, an addition to the same series that includes the NT-1p. The NT-1/1e tonometers were developed without the pachymetry function to address market demand. The NT-1e enables manual measurement with high operability.

Astellas Pharma and Iveric Bio have entered into a definitive agreement under which Astellas through Berry Merger Sub has agreed to acquire 100% of the outstanding shares of Iveric Bio for $40 per share in cash for a total equity value of approximately $5.9 billion. Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas.

Horizon Therapeutics announced the FDA has approved an update to the Indications and Usage section of the Tepezza label to specify its use for the treatment of “Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.”

The FDA accepted for Priority Review Aldeyra Therapeutics’ NDA for ADX-2191 (methotrexate injection, USP), an investigational drug candidate for the treatment of primary vitreoretinal lymphoma.

The FDA cleared the IND application for Aviceda Therapeutics’ AVD-104, enabling the company to proceed with initiating Phase 2 clinical trials of its lead intravitreal ocular asset for the treatment of geographic atrophy secondary to AMD.

Harrow announced the CMS-approved transitional pass-through reimbursement status for IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%, which is indicated for ocular surface anesthesia.