Today’s ODs have a robust armamentarium for treating just about anything that walks through the door, from the ubiquitous red eye to more nuanced conditions such as dry eye and glaucoma. Here’s a preview of what’s coming.
Dry Eye Pipeline
In addition to the usual suspects, clinicians can now consider Klarity-C (Imprimis), a compounded ophthalmic emulsion that contains cyclosporine 0.1% and chondroitin sulfate. Cequa (Sun Pharmaceuticals), which is cyclosporine 0.09% combined with a nanomicellular matrix vehicle to aid in drug penetration, should be available later this year.
These are all in Phase III FDA clinical trials: OCU-310 (Ocugen), CyclASol (Novaliq), T-1580 (Thea), RGN-250 (RegeneRx), Visomitin (Mitotech) and Moisview eye drops (HU-007, Huons).
Other promising drugs in Phase II trials: ADX 102 (Aldeyra); Cambium (Elate Ocular), an autologous serum–derived drop; Novaliq’s NOV03, which contains perfluorohexyloctane; the nasal spray OC-02 (Oyster Point); voclosporin (Aurinia); Lubris (Novartis), a protein-based product; the neurotrophic peptide BRM 421 (Brim Biotechnology); TOP1630 (Topi-Vert), a kinase inhibitor; and SHP-659 (formerly P-321, Shire), an epithelial sodium channel inhibitor.
The list for early-phase clinical trials is even more significant, and I look forward to sharing insights as their clinical results progress.
New Target for Glaucoma
The most exciting development for glaucoma is our ability to treat the trabecular meshwork (TM). The nitric oxide (NO) in Vyzulta (Bausch + Lomb) targets the TM but also affects the blood vessels, allowing for greater outflow. Rhopressa (Aerie) is a rho-kinase inhibitor that expands the TM. In 2019 we may see Rocklatan (Aerie), a Rhopressa/latanoprost combination that shows significant intraocular pressure (IOP)-lowering effects. Sun Pharmaceutical’s Xelpros, another recent approval, is BAK-free and is ideal for glaucoma patients with ocular surface disease.
As for compounding options, Imprimis is a nationwide provider of Simple Drops. The quad formulation is timolol 0.5%/brimonidine 0.15%/dorzolamide 2%/latanoprost .005% in a single preservative-free (PF) 5ml bottle. The triple drop of timolol 0.5%/brimonidine 0.15%/dorzolamide 2% comes in PF 10ml bottles. I recently prescribed triple and quad Simple Drops for a patient who was confused by his dosing and was struggling to reach his target IOP of 16mm Hg. The different bottle sizes help because he takes the triple drop (larger bottle) in the morning and the quad drop in the evening. His pressures are now consistently at 12mm Hg and 13mm Hg.
New anti-VEGF therapies may soon join Lucentis (Genentech), Eylea (Regeneron) and off-label Avastin (Genentech), according to retina specialist John Kitchens, MD. Brolucizumab (Novartis) should gain approval this year. This small molecule acts similarly to other therapies but has a higher molar equivalent and a greater binding affinity. Abicipar (Allergan), which may come in 2020, has similar durability to brolucizumab. Genentech has a Phase III trial of a port-delivery system that may reduce injection frequency and a bi-specific molecule targeting both VEGF and ANG-2.
Red Eye Relief
For years we’ve been telling patients to avoid vasoconstrictor drops—and with good reason. Drops that use oxymetazoline and naphazoline hydrochloride, primarily alpha-1 receptor agonists, affect the arterioles and constrict the eye’s oxygen supply, causing ischemia. The body’s response is vasodilation and tachyphylaxis, leading to overuse and potential corneal toxicity. They also have significant systemic side effects. Thus, patients who want a redness remover should use an alpha-2 receptor agonist such as Lumify (brimonidine 0.025%, Bausch + Lomb). Alpha-2 receptor agonists primarily constrict the venules, which removes the risk of ischemia.
We’ve never had so many new options in so a short time, and we must stay on top of the latest advancements to better manage our patients’ ocular conditions.
Note: Dr. Karpecki consults for a number of manufacturers with products relevant to this topic.