IN THE NEWS

Tarsus Pharmaceuticals announced the FDA approval of XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. XDEMVY, formerly known as TP-03, is the first FDA-approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. The FDA approval is based on results from two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), designed to evaluate the safety and efficacy of XDEMVY.

The FDA approved IZERVAY (avacincaptad pegol intravitreal solution) from Iveric Bio, an Astellas company, for the treatment of geographic atrophy (GA) secondary to AMD. IZERVAY, a new complement C5 inhibitor, is the first approved GA treatment with a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials. In each trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with IZERVAY compared to sham.

DORC received notification from the FDA that its application for Orphan Drug Designation for a dual combination of Trypan Blue and Brilliant Blue G Ophthalmic Solutions has been granted. The proposed indication for the combination ophthalmic solution of 0.15% Trypan Blue and 0.025% Brilliant Blue G is to stain the epiretinal membrane and internal limiting membrane. This is intended to be injected onto the retinal surface, enabling both the epiretinal membrane and internal limiting membrane to be clearly stained to facilitate removal.

RetinalGeniX Technologies was granted a patent for its Patient Home Monitoring and Integrated Physician Alert System for Ocular Anatomy. The device is deployed in the patient’s home, from which an alert can be sent to a remotely located physician, who can then perform a pre-diagnostic evaluation to assess whether an in-person medical diagnosis is warranted. The system may significantly aid in the early diagnosis of systemic disease through high-resolution remote retinal imaging and in-home real-time monitoring.

Oculis Holding AG announced positive topline results from its Phase 3 OPTIMIZE trial with OCS-01 eyedrops, a novel, once-daily, high concentration, preservative-free, topical OPTIREACH formulation of dexamethasone for the treatment of inflammation and pain following ocular surgery. The trial met both hierarchical primary efficacy endpoints — the absence of inflammation at Day 15 and the absence of pain at Day 4, with robust statistical significance. The results emphasize the potential of OCS-01 to be effective in both front and back of eye diseases.

Glaukos Corp. entered into a collaboration and marketing agreement with Radius XR, whereby Glaukos will become the exclusive sales agent to market, promote and solicit orders for the Radius XR wearable patient engagement and diagnostic system within the United States. Radius will continue to lead development and commercialization efforts for Radius XR. The platform is designed to enable efficient detection of eye disease and management and treatment of sight-threatening conditions.

Harrow announced an agreement under which it will acquire the US commercial rights for VEVYE (cyclosporine ophthalmic solution) 0.1%, a patented, nonpreserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol water-free technology. VEVYE is the first FDA-approved cyclosporine-based product indicated for the treatment of both signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks.

Harrow also announced agreements with affiliates of Santen Pharmaceutical Co. under which Harrow will acquire certain US commercial rights for the following branded products from Santen: FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, NATACYN (natamycin ophthalmic suspension) 5%, TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, ZERVIATE (cetirizine ophthalmic solution) 0.24% and FRESHKOTE.

RetinAI Medical AG and Retina Consultants of America (RCA) announced a strategic partnership to develop an extensive and AI-insight driven Real World Evidence US-based database in ophthalmology. This partnership will leverage RetinAI’s digital health technologies and RCA’s network of clinics to analyze real-world health clinical and imaging data. The result will be a comprehensive resource that provides valuable insights into health outcomes, medication adherence and the effectiveness of various treatment protocols.