Palatin Technologies, Inc. (NYSE: PTN) Announces Optimistic End-of-Phase 2 Conference with FDA on PL9643 for the Management of Dry Eye Disease

Palatin Technologies, Inc. (NYSE: PTN) today announced the conclusion of an End-of-Phase 2 (EOP2) conference with the U.S. Food and Drug Administration (FDA) for PL9643 for the management of dry eye disease (DED).

Conference latitude comprised all features of PL9643’s progress plan

The EOP2 conference possibility included all facets of PL9643’s development plan, with the FDA and Palatin accomplishing settlement on all essential rudiments of a critical Phase 3 scientific program. It included study enterprise, endpoints, intervening valuation, and patient population. 

In addition, a probable second Phase 3 study and long-term security study were deliberated to provision a New Drug Application (NDA). Palatin rests on track to introduce the Stage 3 program in DED patients during the fourth quarter of 2021, with statistics readout projected in the second half of the calendar year 2022. If the package headways as intended, an NDA proposal is directed for the second half of the calendar year 2023.

“As a working ophthalmologist, I am fortified by the statistics to date on the PL9643 package,” said Michael Raizman, M.D., Chief Medical Officer of Palatin. 

PL9643 is a novel melanocortin agonist, transported to the eye topically via eyedrops. Palatin beforehand announced optimistic fallouts in its Phase 2 study of PL9643 for the cure of DED. 

About Melanocortins and Irritation

 The melanocortin receptor (“MCr”) scheme affects nourishment intake, absorption, sexual function, irritation, and resistance system rejoinders. There are five melanocortin receptors, MC1r complete MC5r. Inflection of these receptors by using receptor-specific agonists, which trigger receptor purpose, or receptor-specific antagonists, which block receptor function, can have significant pharmacological effects.

Dry eye illness is a common demagogic disease that, left untouched, can become tremendously sore and lead to enduring injury to the cornea and vision. Dry eye illness affects the eye’s cornea and conjunctiva, resulting in annoyance, soreness, pain, and blurry vision.

Leave a Comment

Your email address will not be published.