Here's a look at some of the latest news regarding ophthalmic drugs and therapies from the past week.
- Aerie Pharmaceuticals, Inc. has received notification from the U.S. FDA that the FDA has completed its initial 60–day review of the Rhopressa™ NDA (new drug application) and determined that the application is sufficiently complete to permit a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Rhopressa NDA is set for February 28, 2018.
- ONL Therapeutics, Inc. has closed a $4.25 million Series A round of fundraising. Proceeds from the fundraising, combined with the recently announced $1 million grant from the National Eye Institute, will reportedly primarily be used to finalize preclinical development of ONL1204 — the company's lead therapeutic candidate — in preparation for clinical trials as a potential treatment for retinal detachment.
- Pharmaleads announced positive efficacy and safety results of PL265 — a novel Dual ENKephalinase Inhibitor (DENKI) — in a preclinical study for ocular pain at the Association for Research in Vision and Ophthalmology (ARVO) 2017 Annual Meeting last week. The study was reportedly conducted in collaboration with The Vision Institute in Paris, France, and assessed the anti-nociceptive effect of PL265 in experimental models of ocular pain/dry eye syndrome.
- Isarna Therapeutics reported positive Phase I safety and efficacy data for its lead candidate ISTH0036 — a locked nucleic acid-modified antisense oligonucleotide — in advanced-stage glaucoma patients at ARVO 2017. Overall, the treatment was reportedly safe and well tolerated at all dose levels, and the post-operative intraocular pressure course provided preliminary evidence for a beneficial effect of ISTH0036 at the two highest dose levels.
- Aldeyra Therapeutics, Inc. presented the results of a Phase 2 clinical trial of topical ocular ADX-102 — a first-in-class aldehyde trap — at ARVO 2017. Data from the trial reportedly demonstrated ADX-102 activity comparable to standard-of-care topical ocular corticosteroids in reducing anterior chamber cell count in patients with active noninfectious anterior uveitis (NAU).
- And Ocular Services on Demand LLC, a consortium of experts in vision science working to accelerate the identification and development of new ophthalmic therapies and devices, recently announced the availability of a new 16-hour continuing education series that focuses on the basic science that underlies ocular drug and device development. Topics covered reportedly include comparative ocular functional morphology, ocular physiology and pharmacology, ocular immunology, electrodiagnostics, clinical assessment and use of scoring systems, advanced imaging techniques and ocular pathology.
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