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Ophthalmic Professional

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Opening Lines

Ophthalmic Professional September 1, 2023 Vol 12, Issue September/October 2023 Page(s): 5

Recent FDA-approved drugs

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. XDEMVY is expected to be available by prescription by the end of August 2023. 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 in 833 patients, 415 of which received XDEMVY. Efficacy was demonstrated by a significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than two collarettes per upper lid) in each study by Day 43, with some patients seeing improvement as early as 2 weeks.

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. The FDA approval was based on these Phase 3 clinical trials: GATHER1 and GATHER2. In each registrational trial, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with IZERVAY over a 12-month period compared to sham. Slowing of disease progression was observed as early as 6 months with up to a 35% reduction in the first year of treatment. At time of approval, IZERVAY was anticipated to be available by early September.

CORRECTION

In the July/August Ophthalmic Professional article, “It’s all about training,” two numbers were inadvertently transposed in Figure 7 (P.11). The figures should read: 68% of ophthalmic professionals report their practices use live media (in-person meetings, seminars, etc.) for professional education/training, and 87% report their practices use online media (webinars, online courses, etc.) for such training. Ophthalmic Professional regrets the error.

In Brief

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.

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.

Eyenuk received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy. The regulatory clearance of the EyeArt v2.2.0 system makes it the first AI system that is FDA-cleared for use with multiple retinal cameras by different manufacturers.

Bausch + Lomb entered into a definitive agreement with Novartis under which Bausch + Lomb will acquire XIIDRA (lifitegrast ophthalmic solution) 5%, a non-steroid eyedrop to treat the signs and symptoms of DED focusing on inflammation associated with dry eye. As part of the transaction, Bausch + Lomb will also acquire libvatrep and AcuStream technology. The transaction was approved by the board of directors at each of the respective companies and is expected to close by the end of 2023.

RetinalGeniX Technologies was granted a patent for its Patient Home Monitoring and Integrated Physician Alert System for Ocular Anatomy. The invention relates to a home monitoring device deployed in the patient’s residence, from which an alert can be sent to a remotely located physician, who can then perform a pre-diagnostic evaluation remotely to assess whether an in-person medical diagnosis is warranted.

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 selectively stain the epiretinal membrane (ERM) and internal limiting membrane (ILM).

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