Eyes on New Product Development

• Avedro reached agreement on a phase 3 study of their Photrexa Viscous^® (riboflavin 5′-phosphate in 20% dextran ophthalmic solution) for the treatment of progressive keratoconus using an “epithelium-on” procedure. The current approved procedure for Photextra^® is “epithelium-off” (March 2018).

• Genentech received U.S. Food and Drug Administration (FDA) approval for a prefilled syringe of Lucentis^® (ranibizumab) for the treatment of all forms of diabetic retinopathy (March 2018).

• Ocugen announced results of a phase 2 study of OCU310 (a fixed dose combination of brimonidine and loteprednol etabonate) for the treatment of dry eye disease (March 2018).

• Opthea started enrollment in a phase 2b study of its OPT-302 VEGF-C/D “trap” therapy in patients with wet AMD. The treatment is in conjunction with Lucentis (ranibizumab, April 2018).

• pSivida announced that the FDA accepted its New Drug Application for its intravitreal fluocinolone acetonide implant for the treatment of uveitis (March 2018). The firm also announced that it acquired Icon Bioscience, which recently received approval for an intraocular (anterior chamber) dexamethasone for the treatment of postoperative inflammation, DexyCu™, and renamed itself EyePoint Pharmaceuticals (April 2018).

• Regeneron announced results of a phase 3 study of Eylea^® (aflibercept) for the treatment of severe nonproliferative diabetic retinopathy (March 2018).

• Ophthea dosed the first patients in Europe and Israel with its OPT-302 in a phase 2b study in patients with wet AMD, according to a press release.

• The Pediatric Eye Disease Investigator Group has started a 2-year, controlled clinical trial to evaluate the efficacy and safety of 0.01% topical ocular atropine to slow the progression of myopia, a topic reviewed in this issue. ¹

• Thombogenics announced results of a phase 1/2 study of its THR-001 human placental growth factor antibody in the treatment of diabetic macular edema (April 2018).

• Nicox and Bausch + Lomb renegotiated their financial terms on the recently approved Vyzulta^® (latanoprostene bunod; March 2018).

• The impact of recent drug pricing transparency law in California on current drug prices is variable and largely unknown (March 2018).