Eyeworld

C ORNEA 14 | EYEWORLD BONUS ISSUE | OCTOBER 2025 Relevant disclosures de Luise: None Sheppard: AbbVie, Alcon, Bausch + Lomb, Bio-Tissue, Claris Bio, Dompe, Mallinckrodt, Novaliq, Noveome Contact de Luise: vdeluisemd@gmail.com Sheppard: jsheppard@cvphealth.com continued from page 13 address that type first, Dr. de Luise said. "This strategy also makes sense given ongoing chal- lenges in trying to get insurance coverage for a patient to obtain a specific DED prescription, let alone two (or more) DED medications." Future products There are several dry eye medications in the pipeline that could potentially expand the abil- ity to individualize treatment of dry eye based on type, symptoms, and signs. (This is not an exhaustive list and does not represent all dry eye medications currently being researched.) Reproxalap (Aldeyra Therapeutics): Aldeyra announced in May that its RASP-inhibitor, reproxalap, achieved statistical significance against vehicle comparator in the primary outcome sign metric of patient-reported ocu- lar discomfort. Reproxalap is also efficacious for allergic conjunctivitis, making this the first agent to simultaneously treat both comorbid conditions other than steroids, Dr. Sheppard said. AZR-MD-001 (Azura Ophthalmics): This is a selenium sulfide keratolytic gel meant to be applied twice weekly to dissolve keratin and melt inspissated meibum. The Phase 3 study is looking at AZR-MD-001 in patients with clinical signs and symptoms of MGD, Dr. de Luise said, adding that there is no currently available FDA-approved medication labeled specifically for MGD. Lacripep (Tear Solutions): Lacripep is a stable, water-soluble, C-terminal synthetic peptide fragment derived from lacritin tear protein. Lacritin is a foundational ocular surface protein in normal tears that is diminished to absent in the tears of DED patients. Lacripep may also possess neuroregenerative properties and efficacy in neurotrophic keratopathy, a co- morbidity often seen in severe cases of DED, Dr. de Luise said, adding that Tear Solutions has completed DED patient enrollment in the setting of Sjogren's disease. OCS-02 (Oculis): This is the TNF-alpha inhibi- tor licaminlimab, which has anti-inflammatory and regenerative (anti-apoptotic) mechanisms of action, Dr. de Luise said. In the Phase 2b trial, OCS-02 demonstrated symptom im- provement as early as 2 weeks. PL9643 (Palatin Technologies): According to Dr. de Luise, this is a melanocortin receptor modulator with rapid onset of action and symptom resolution across multiple DED endpoints. The MELODY-1 trial has been completed, and the MELODY-2 and confirma- tory MELODY-3 clinical trials are planned. Dr. Sheppard noted that systemic administration of melanocortin receptor immune modula- tors is indicated for a wide variety of ocular inflammatory diseases, including severe kera- titis, uveitis, and scleritis. ST-001 vezocolmitide (Stuart Ophthalmics): This is a collagen mimetic peptide that Dr. de Luise said selectively repairs disease-dam- aged ocular surface collagen and reduces oxidative stress and inflammation. A Phase 2 trial showed rapid relief of symptoms and improvement in tear function within 28 days. TP-03 (Tarsus): The acaricide lotilaner is being evaluated for use in meibomian gland dysfunction in ERSA and RHEA trials. Dr. de Luise also mentioned Visomitin SkQ1 (Mitotech), a mitochondria-targeted antioxidant to treat dry eye disease by scavenging reactive oxygen species and inflammation; SURF-200 (betamethasone in Klarity vehicle, Surface Ophthalmics) for the treatment of acute dry eye disease; and GLK-301 (Glaukos), a topical ophthalmic pilocarpine-based cream for dry eye disease. Several other companies, such as Kala Phar- maceuticals (KPI-012), Claris Bio (CSB-001), and Krystal Biotech (KB801) are evaluating topical growth factors for neurotrophic keratop- athy, a complex corneal condition that can over- lap with the corneal changes in severe DED, Dr. de Luise said. The Claris Bio hepatocyte growth factor provides additional potential benefits including anti-fibrosis and anti-apoptosis in the context of ocular surface and corneal healing, Dr. Sheppard noted. "The DED pipeline has never been more robust, and along with the many DED medi- cations that have been FDA approved over the years, ophthalmologists have an ever-increasing toolkit of effective strategies to begin to indi- vidualize DED therapy and target DED by type, symptom, and severity," Dr. de Luise said. "Our therapeutic strategies have become far more sophisticated than the early days of this century when topical cyclosporine was the only approved medication for DED," Dr. Sheppard said. "We now have choices analo- gous to synergistic therapies for glaucoma or hypercholesterolemia."

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