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Future looks optimistic for ophthalmology
According to a recent speech by Scott Gottlieb, MD, the current FDA commissioner, today’s FDA is committed to expediting development of breakthrough drugs and is in favor of more rapid and less costly development programs. Thanks to the efforts of Wiley Chambers, MD, Malvina Eydelman, MD, and their teams charged with approving new ophthalmic drugs and devices, 2017 and 2018 in the field of ophthalmology were banner years. While hematology, oncology, and rare and orphan drugs represented the highest number of approvals, ophthalmology was well represented.
If and when it occurs, the proposed reorganization on the drug side with a separate Division of Ophthalmology within the Office of Specialty Medicines will be a great benefit to those of us active in innovation in ophthalmology. Both the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery have been supportive of this reorganization, as have the strategics and many of we ophthalmologists active in our field. I hope we see this reorganization come to fruition in 2019.
On the drug side, we experienced an amazing past 2 years. The approval of Vyzulta (latanoprostene bunod 0.024%) from Bausch + Lomb and Rhopressa (netarsudil 0.02%) from Aerie Pharmaceuticals strengthened our medical armamentarium for glaucoma. The approval of a Rho kinase inhibitor represented the first new class of glaucoma drops approved in nearly 20 years.
The injectable bioerodible dexamethasone suspension 9% in 5 µL for injection into the anterior chamber after cataract surgery from EyePoint Pharmaceuticals, Dexycu, and its sister, Yutiq, containing 0.18 mg of fluocinolone acetonide for intravitreal injection to treat noninfectious posterior uveitis, both represent major and unique advances in our ability to manage intraocular inflammation. On the topical side, Inveltys (loteprednol etabonate suspension 1%, Kala Pharmaceuticals) provides our first twice-daily topical steroid for the treatment of pain and inflammation after cataract surgery.
Oxervate (cenegermin) ophthalmic solution from Dompé farmaceutici SpA is a human nerve growth factor for the treatment of neurotrophic keratitis and achieved expedited approval. Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics represented the first gene therapy approved to treat an inherited disease in ophthalmology, biallelic RPE65 mutation-associated retinal dystrophy. Reports suggest this is just the beginning in the field of gene therapy, as the FDA has more than 700 active applications for gene therapy, and ophthalmology is well represented.
Cequa from Sun Pharma, a preservative-free 0.09% cyclosporine drop, was added to our dry eye therapy options.
Research continued in the quest to develop new adjuncts for wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion, but no new candidates were approved. Several failures of once-promising candidates after expensive clinical trials shocked the retina community.
On the device side, several significant approvals also occurred recently. After more than a decade of study, the CustomFlex artificial iris (HumanOptics) was approved. On the IOL side, the RxSight Light Adjustable Lens and Light Delivery Device were approved as was the Bausch + Lomb enVista hydrophobic acrylic toric IOL. The Bausch + Lomb Ultra contact lenses also achieved approval.
In a banner year for glaucoma with two new drug approvals, the Glaukos iStent inject and Ivantis Hydrus microstent were both approved, expanding the MIGS category. In an unexpected setback, concerns regarding endothelial cell loss caused Alcon to voluntarily withdraw the CyPass micro-stent. The STAAR Visian toric ICL was approved, significantly expanding the options for the refractive surgeon.
In addition, artificial intelligence appeared on the scene with the approval of the IDx-DR system (IDx LLC) for the automatic detection and grading of diabetic retinopathy.
All in all, an amazing period for ophthalmology, with much optimism for the future as the pipeline is robust and our field continues to attract and support investment.
Disclosure: Lindstrom reports he consults for Bausch Health, Aerie, RxSight, Kala and Sun.