LONDON – A year on from delivering positive phase IIb data, Oculis SA has raised $57 million in an oversubscribed series C, to take OCS-01, a topical nanoparticle formulation of dexamethasone, through two phase III trials.
Lexington, Mass.-based Aldeyra Therapeutics Inc.’s phase III win in the study called Invigorate with reproxalap for allergic conjunctivitis (AC) restarted speculation about odds of the drug, a small-molecule, immune-modulating covalent inhibitor of reactive aldehyde species (RASP), to treat dry eye disease (DED). “I do think there is potential read-through,” CEO Todd Brady said, especially with regard to the redness endpoint. A six-week safety study necessary before going to the FDA has not yet started, he told investors during a conference call. “That will require some discussions with the FDA, but I do not think, given the length of the trial, the safety study would impair our guidance of potentially filing NDAs by the end of this year.”
Stuart Therapeutics Inc., a company developing peptide therapeutics for ophthalmic disease, has completed an $11 million series A financing led by Infocus Capital Partners, an ophthalmology-focused life sciences venture capital fund, with significant participation by the Wisconsin Alumni Research Foundation, Mimo Capital and Biobrit.
At the end of March, JAMA Ophthalmology’s publication of first results from the NIH-sponsored, 328-patient trial with Regeneron Pharmaceuticals Inc.’s VEGF inhibitor, Eylea (aflibercept), in non-proliferative diabetic retinopathy bolstered investor hopes for wider use. But competitors loom for the compound, first approved in November 2011 for wet age-related macular degeneration.
Lianbio Co. Ltd. has inked a $200 million deal with Tarsus Pharmaceuticals Inc. for greater China rights to the phase IIb/III-stage candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), designed to treat Demodex blepharitis and Meibomian gland disease.
RNA therapy developer Proqr Therapeutics NV’s phase I/II study of adults with Usher syndrome and non-syndromic retinitis pigmentosa met all its key objectives, prompting the company to plan two parallel pivotal phase II/III studies that could start by year-end. The company wasted no time as it has already discussed next steps with the FDA to support the therapy’s registration “as soon as possible,” Aniz Girach, Proqr’s chief medical officer, told investors during a March 24 investor call.
Aura Biosciences Inc., a company developing a virus-like drug conjugate (VDC) for the potential treatment of a type of rare ocular cancer, has closed an oversubscribed $80 million financing.
HONG KONG –Uni-Bio Science Group Ltd. and Dotbio Pte. Ltd. formed a partnership to develop therapeutics for patients with retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal neovascularization.
PERTH, Australia – Sydney-based Azura Ophthalmics Ltd. has moved into a registration trial following positive phase II results for lead candidate AZR-MD-001 in Meibomian gland dysfunction, the leading cause of dry eye disease.
Chinese eye disease specialist Arctic Vision Biotechnology Co. Ltd. raised more than $100 million in a series B financing round. The clinical-stage company will use the funds to initiate a phase III trial for its core asset, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension), for uveitic macular edema in China this year.