Over the next two weeks, the team at NGM Biopharmaceuticals Inc. will be digging through the data from its phase II trial of complement 3 inhibitor NGM-621 in patients with geographic atrophy (GA) secondary to age-related macular degeneration, following reports of a top-line miss Oct. 17 and a severe reaction from investors, who sent shares (NASDAQ:NGM) plummeting 70.5% to close at $3.41.
Kriya Therapeutics Inc. has presented preclinical data on their novel candidate, KT-A261, an adeno-associated viral vector serotype 2 (AAV2) encoded to express adalimumab, administered as a single intravitreal injection to improve ocular concentrations of adalimumab, for the potential treatment of noninfectious uveitis (NIU).
Glaucoma is an eye disease that damages the optic nerve, with the main cause being ocular hypertension due to high resistance to the outflow of aqueous humor.
Surrozen Inc.’s back-end-loaded deal with Boehringer Ingelheim GmbH for the preclinical frizzled class receptor 4 agonist SZN-413 takes aim at vascular function in retinal diseases. The arrangement brings an up-front payment to South San Francisco-based Surrozen of $12.5 million, plus up to $586.5 million in potential development, regulatory and commercial milestone rewards, along with mid-single-digit to low-double-digit royalties on sales. After an initial period of joint research, Boehringer, of Ingelheim, Germany, will take over development and commercial responsibilities.
Trefoil Therapeutics Inc. has reported promising data from a phase II trial suggesting its engineered version of fibroblast growth factor 1, TTHX-1114, may speed and improve recovery of patients with Fuchs endothelial corneal dystrophy who are undergoing a surgical procedure called Descemet stripping only.
A Surrozen Inc. research team has reported preclinical data for the novel frizzled class receptor 4 (FZD4) agonist, SZN-413, being evaluated for the treatment of diabetic retinopathy. In vitro studies using the Norrin mimetic (SZN-413-p) revealed that SZN-413-p induced Wnt/β-catenin signaling and upregulated blood-brain barrier/blood-retina barrier gene expressions in endothelial cells.
The U.S. FDA approved Santen Pharmaceutical Co. Ltd.’s and UBE Industries Ltd.’s Omlonti (omidenepag isopropyl) ophthalmic solution for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. It is the second FDA-approved product from Japan-based Santen in the last 15 months for patients in the U.S. with vision conditions.
It took resolving issues from two complete response letters for Fennec Pharmaceuticals Inc. to finally land U.S. FDA approval of Pedmark. The injectable formulation of sodium thiosulfate is for reducing the risk of platinum-induced ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors. Approval of the NDA arrived Sept. 20, three days before its Sept. 23 PDUFA date.
Ocular gene therapy firm Sparingvision SA raised €75 million (US$75 million) in a series B round to fund its transition to clinical development. The company is about to move its lead program, the mutation-agnostic gene therapy SPVN-06, into a phase I trial in retinitis pigmentosa (RP). “We are in the middle of the regulatory submission process,” CEO Stéphane Boissel told BioWorld.
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