Santen Receives FDA Approval for Verkazia for Vernal Keratoconjunctivitis
Santen announced the FDA approved Verkazia (cyclosporine ophthalmic emulsion) 0.1% eye drops for the treatment of vernal keratoconjunctivitis in children and adults. Verkazia is a prescription-only, oil-in-water cationic emulsion that the company says provides improved ocular bioavailability of cyclosporine, which has been shown to be effective in the management of VKC. It works by inhibiting T-cell activation and reducing the level of immune cells and mediators that cause the allergic inflammation of the ocular surface seen in those affected by VKC. Read more.
Regenerative Patch Technologies Announces Results from Phase I/IIa Trial
Regenerative Patch Technologies announced results from its Phase I/IIa clinical trial of its CPCB-RPE1 implant for dry age-related macular degeneration. The CPCB-RPE1 implant, a bio-engineered scaffold supporting a layer of stem cell-derived retinal pigmented epithelial cells, was delivered to the worst eye of 15 subjects with geographic atrophy. All treated eyes had a best-corrected visual acuity of 20/200 or worse. At an average of 34 months post-implantation, 27 percent (4/15) showed a greater than five-letter improvement in BCVA, and 33 percent (5/15) remained stable with a BCVA within five letters of baseline. Read more.
Glaukos Completes Patient Enrollment in Phase III iDose TR Trials
Glaukos completed patient enrollment and randomization for its FDA New Drug Application Phase III clinical trials for the iDose TR sustained-release travoprost implant. The clinical program will compare the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates to topical timolol ophthalmic solution, 0.5% b.i.d., in reducing elevated intraocular pressure in subjects with open-angle glaucoma or ocular hypertension. Read more.
Atsena Receives FDA Orphan Drug Designation for Gene Therapy
Atsena Therapeutics announced the FDA granted orphan drug designation for its investigational gene therapy product for the treatment of GUCY2D-associated Leber’s congenital amaurosis. The safety and efficacy of the therapy are being evaluated in a Phase I/II clinical trial, which is currently enrolling patients. Read more.
Amydis Receives $3 Million Grant for Novel Amyloid Beta Retinal Tracer
Amydis announced an award of a $3 million grant from the National Institute of Aging at the National Institutes of Health. The two-year Commercialization Readiness Pilot Program award will provide additional funding toward a clinical trial to test Amydis’ small-molecule retinal tracer targeting the biomarker amyloid beta for the diagnosis of amyloid angiopathy. Read more.
Recycling of the Eye’s Light Sensors is Faulty in Progressive Blindness
University of Maryland School of Medicine researchers have found the process that removes the eye’s old photoreceptors is disrupted in age-related macular degeneration, according to the findings published June 23 in Nature Communications. The team compared healthy mouse eyes to those from a mouse engineered without the CIB2 protein, which is needed for vision, and found the CIB2 mutant mice weren’t getting rid of their old photoreceptors like healthy mouse eyes did. They identified several components in a photoreceptor recycling process, including mTORC1 proteins, that clean up cellular debris. The proteins were overactive in CIB2 mutant mice and in human eye tissue samples from individuals with AMD. The researchers say the findings suggest that drugs against mTORC1 might be effective treatments for the most common type of AMD. Read more.
Aurion Names Dr. Holland Chief Medical Advisor
Edward Holland, MD, was named chief medical advisor of Aurion Biotech. Dr. Holland will help advance the company’s lead candidate, cell therapy for the treatment of corneal endothelial disease, and help expand the company’s platform of therapies. Read more.
Second Sight Announces Closing of Public Offering
Second Sight Medical Products announced the closing of its previously announced underwritten public offering of 11,500,000 shares of its common stock at a public offering price of $5 per share. The company intends to use the net proceeds for development of the Orion device and general corporate purposes. Read more.
Dexycu to Get New Category III CPT Code
EyePoint Pharmaceuticals announced that the American Medical Association’s Current Procedural Terminology Editorial Panel accepted the addition of a new Category III CPT code, 0X78T, for the administration of a drug into the posterior chamber of the anterior segment of the eye, effective January 1, 2022, which EyePoint says provides an opportunity for a reimbursement pathway for the administration of Dexycu, the company’s single dose, sustained-release, intracameral steroid for the treatment of postoperative inflammation. Learn more.
Topical Presbyopia Treatment Set to Move to Phase III
Ocuphire Pharma announced that its VEGA-1 Phase II clinical trial of Nyxol in combination with low-dose pilocarpine (LDP) in presbyopes met its primary and many secondary endpoints. Specifically, 61 percent of subjects treated with Nyxol + LDP improved 15 letters or greater (≥ 3 lines) in photopic binocular near vision at one hour compared with 28 percent of subjects on placebo with statistical significance (p=0.003 with placebo-adjusted difference of 33 percent). Ocuphire now plans to move the drug into Phase III. Read more.