NEW YORK (Reuters Health) – Six-month follow-up data from a phase II trial of Cambridge Antibody Technology's ophthalmic agent CAT-152 suggest the injectable drug helps lower intraocular pressure (IOP) in patients who have undergone combined glaucoma and cataract surgery, the company said on Wednesday.
CAT-152 (lerdelimumab; human anti-TGF Beta 2 monoclonal antibody) is designed to prevent excessive post-operative scarring that "is the major reason why glaucoma surgery can fail to lower intraocular pressure in the long term," according to the firm.
At six months, resumption of longterm topical IOP-lowering medication was needed in 8% of the treatment group, compared with 15% of the placebo group, the company reported.
Cambridge Antibody hopes the new data, presented at the annual meeting of the American Academy of Ophthalmology, will help allay concerns raised by three-month results released in August.
The three-month data suggested that CAT-152 was safe and tolerable-the study's primary endpoint–but did not demonstrate efficacy. The six-month results show "a clearer trend towards a better longterm outcome in those patients treated with CAT-152 than was apparent in the three-month follow-up results," Cambridge Antibody's medical director, Dr. David Glover, said.
The phase II trial enrolled 56 patients undergoing both glaucoma and cataract surgery. Thirty-six subjects received CAT-152 and 20 received placebo in subconjunctival injections given immediately before and after surgery, as well as on the day after surgery and one week after surgery, the firm said.
The six-month data bear out CAT-152's safety, with no serious drug-related adverse events and no severe injection-site reactions reported, the firm said. There was also no evidence of increased inflammation in the eye's anterior chamber, it added.
Full results will include 12 months of follow-up data, a company spokesman told Reuters Health.
Cambridge Antibody's shares closed up 0.65 at 27.45 on the NASDAQ.
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